NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Study Details
Study Description
Brief Summary
This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will compare the 2 currently recommended NGU treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone. Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last 7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2 urethral swabs, and have their urethra checked for discharge indicating infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study represents a clinical evaluation of the use of combination therapy for the initial treatment of non-gonococcal urethritis (NGU). This study will provide more current data on the comparison of cure rates between the 2 currently recommended therapies for NGU, doxycycline and azithromycin. Emerging clinical data has suggested that the latter may have become more efficacious for NGU as it is more effective in eradicating Mycoplasma (M.) genitalium from the genital tract than the former. Only in vitro data, limited as it is, suggests that doxycycline should be active against M. genitalium. The researchers hypothesize that cure rates for NGU will be significantly improved for both doxycycline and azithromycin using combination therapy with tinidazole. Important safety and tolerability data will be collected with regards to the use of combination therapy. Additionally, the study will provide data on the prevalence of the targeted pathogens in 4 geographic areas and on characteristics of men with NGU that may help to target populations who would benefit the most from combination therapy. The researchers hypothesize that currently recommended initial therapies for NGU are inadequate in at least certain populations due to lack of coverage for Trichomonas (T.) vaginalis. The researchers further hypothesize that between the 2 currently recommended regimens, azithromycin will result in a greater number of cures than doxycycline due to its greater efficacy in M. genitalium infected men. The primary study objectives are to: compare the clinical cure rates of doxycycline versus doxycycline with tinidazole; and azithromycin versus azithromycin with tinidazole for the treatment of NGU; and to evaluate the safety and tolerability of doxycycline/tinidazole and azithromycin/tinidazole in the treatment of NGU. Secondary study objectives are to: evaluate microbiological cure of Chlamydia (C.) trachomatis, T. vaginalis, M. genitalium in men treated with doxycycline versus doxycycline with tinidazole; and azithromycin versus azithromycin with tinidazole. Analysis will also include: (doxycycline plus doxycycline/tinidazole) versus (azithromycin plus azithromycin/tinidazole); for the clinical cure rates, analysis will also include: (doxycycline plus doxycycline/tinidazole) versus (azithromycin plus azithromycin/tinidazole); determine the prevalence of C. trachomatis, T. vaginalis, and M. genitalium in the study population of men with non-gonococcal urethritis; determine clinical, behavioral, and demographic predictors of the above organisms in men with non-gonococcal urethritis; and collect specimens for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis. Outcome measures include clinical failure, clinical cure, microbiological cure, and unevaluable cure assessed at the first and second follow-up visits. Study participants will include 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Subjects will be randomly assigned to 1 of 4 active treatment arms: 75 subjects doxycycline; 75 subjects doxycycline plus tinidazole; 75 subjects azithromycin; and 75 subjects azithromycin plus tinidazole.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Doxycycline Doxycycline 100 mg orally twice daily (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin orally single dose and placebo tinidazole. |
Other: Placebo
Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.
Drug: Doxycycline
100 mg orally, twice daily for 7 days.
|
| Experimental: Doxycycline + Tinidazole Doxycycline 100 mg orally twice daily for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm orally single dose (4 tablets at 500 mg each). |
Drug: Tinidazole
2 gm single dose (4 tablets orally at 500 mg each).
Other: Placebo
Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.
Drug: Doxycycline
100 mg orally, twice daily for 7 days.
|
| Experimental: Azithromycin Azithromycin 1 gram (gm) orally single dose (2 tablets at 500 milligrams (mg) each) plus doxycycline placebo twice daily for 7 days plus tinidazole placebo single dose. |
Other: Placebo
Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.
Drug: Azithromycin
1 gram (gm) (2 tablets orally at 500 milligrams (mg) each).
|
| Experimental: Azithromycin + Tinidazole Azithromycin 1 gm orally single dose (2 tablets at 500 mg each) plus doxycycline placebo twice daily for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
Drug: Tinidazole
2 gm single dose (4 tablets orally at 500 mg each).
Other: Placebo
Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.
Drug: Azithromycin
1 gram (gm) (2 tablets orally at 500 milligrams (mg) each).
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
- Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
- Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
At all study visits, unsolicited adverse events were recorded.
- Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
- Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
- Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit. Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs). Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)
Secondary Outcome Measures
- Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit. Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 PMNs per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs). Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)
- Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline.
- Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen).
- Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole [First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline.
- Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis [Baseline (enrollment visit)]
Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment)
- Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis [Baseline (enrollment visit)]
Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment)
- Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis [Baseline (enrollment)]
Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment)
- Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis [Baseline (enrollment visit)]
Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months.
- Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis [Baseline (enrollment visit)]
Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months.
- Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis [Baseline (enrollment visit)]
Logistic multiple regression with independent variable selection based on single variable models with p<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months.
- Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis [Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]
Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male, 16 to 45 years old.
-
Symptoms of non-gonococcal urethritis (NGU), including urethral discharge and/or dysuria for less than or equal to 14 days, or urethral discharge on exam.
-
Urethral smear with greater than or equal to 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields.
-
Willing to abstain from sexual intercourse or use condoms during the study.
-
Willingness to provide written consent.
Exclusion Criteria:
-
Presence of gonorrhea at baseline visit.
-
History of recurrent non-gonococcal urethritis (NGU) (3 or more episodes in the prior year) or history of recent NGU (within past 30 days).
-
Signs or symptoms of epididymitis or prostatitis.
-
Known allergy to or intolerance of tinidazole, tetracyclines, macrolides or metronidazole.
-
History of photosensitivity related to doxycycline use.
-
Received systemic antibiotics within 30 days of study enrollment.
-
Unwillingness to abstain from alcohol for 24 hours after enrollment.
-
Serious underlying infection, including known HIV or other primary or secondary immunosuppression.
-
Concomitant infection, which requires antimicrobial therapy.
-
History of mental illness, which would preclude responsible participation in the study.
-
Current drug abuse that might affect ability to follow the protocol.
-
Previously enrolled in this study.
-
Men who have sex with men, due to different microbiology of NGU.
-
Voided within the previous hour.
-
Ingested alcohol within the past 8 hours.
-
Subject requires concurrent lithium, anticoagulation therapy, or antabuse.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Hospital - Infectious Diseases | Birmingham | Alabama | United States | 35249-0001 |
| 2 | Delgado Personal Health Center | New Orleans | Louisiana | United States | 70112-3503 |
| 3 | Johns Hopkins Hospital - Emergency Medicine | Baltimore | Maryland | United States | 21287-0005 |
| 4 | University of North Carolina School of Medicine - Center for Infectious Diseases | Chapel Hill | North Carolina | United States | 27599-7030 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05-0120
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Period Title: Overall Study | ||||
| STARTED | 76 | 73 | 77 | 79 |
| COMPLETED | 56 | 49 | 51 | 53 |
| NOT COMPLETED | 20 | 24 | 26 | 26 |
Baseline Characteristics
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). | Total of all reporting groups |
| Overall Participants | 76 | 73 | 77 | 79 | 305 |
| Age (Count of Participants) | |||||
| <=18 years |
1
1.3%
|
1
1.4%
|
2
2.6%
|
3
3.8%
|
7
2.3%
|
| Between 18 and 65 years |
75
98.7%
|
72
98.6%
|
75
97.4%
|
76
96.2%
|
298
97.7%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
27.3
(7.0)
|
27.8
(6.8)
|
26.4
(6.7)
|
25.7
(7.2)
|
26.8
(6.9)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
76
100%
|
73
100%
|
77
100%
|
79
100%
|
305
100%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
76
100%
|
73
100%
|
77
100%
|
79
100%
|
305
100%
|
Outcome Measures
| Title | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea |
|---|---|
| Description | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 77 | 79 |
| Number [Participants] |
3
3.9%
|
4
5.5%
|
0
0%
|
4
5.1%
|
| Title | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting |
|---|---|
| Description | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 77 | 79 |
| Number [Participants] |
4
5.3%
|
2
2.7%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) |
|---|---|
| Description | Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit. Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 PMNs per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs). Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs) |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo |
| Arm/Group Title | Doxycycline + (Doxycycline + Tinidazole) | Azithromycin + (Azithromycin + Tinidazole) |
|---|---|---|
| Arm/Group Description | Doxycycline 100 mg PO BID (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin PO single dose and placebo tinidazole + (Doxycycline 100 mg PO BID for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm PO single dose (4 tablets at 500 mg each)). | Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each)) |
| Measure Participants | 149 | 156 |
| Number [Percentage of participants] |
49
64.5%
|
44
60.3%
|
| Title | Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole |
|---|---|
| Description | Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline. |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who were positive at baseline, returned for follow-up, and had evaluable test results. |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 34 | 24 | 26 | 25 |
| Number [Percentage of participants] |
89
117.1%
|
75
102.7%
|
66
85.7%
|
61
77.2%
|
| Title | Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole |
|---|---|
| Description | Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen). |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who were positive at baseline, returned for follow-up, and had evaluable test results. |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 9 | 9 | 7 | 5 |
| Number [Percentage of participants] |
55
72.4%
|
75
102.7%
|
56
72.7%
|
50
63.3%
|
| Title | Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole |
|---|---|
| Description | Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline. |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who were positive at baseline, returned for follow-up, and had evaluable test results. |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 21 | 18 | 22 | 23 |
| Number [Percentage of participants] |
23
30.3%
|
32
43.8%
|
52
67.5%
|
68
86.1%
|
| Title | Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis |
|---|---|
| Description | Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment) |
| Time Frame | Baseline (enrollment visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All study participants with evaluable baseline test results. |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 77 | 79 |
| Number [Percentage of participants] |
50
65.8%
|
38
52.1%
|
38
49.4%
|
46
58.2%
|
| Title | Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis |
|---|---|
| Description | Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment) |
| Time Frame | Baseline (enrollment visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All study participants with evaluable baseline test results. |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 77 | 79 |
| Number [Percentage of participants] |
14
18.4%
|
16
21.9%
|
12
15.6%
|
10
12.7%
|
| Title | Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis |
|---|---|
| Description | Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment) |
| Time Frame | Baseline (enrollment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All study participants with evaluable baseline test results. |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 76 | 79 |
| Number [Percentage of participants] |
29
38.2%
|
30
41.1%
|
32
41.6%
|
32
40.5%
|
| Title | Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis |
|---|---|
| Description | Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months. |
| Time Frame | Baseline (enrollment visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures. |
| Arm/Group Title | All Participants Analyzed |
|---|---|
| Arm/Group Description | |
| Measure Participants | 290 |
| Positive for Chlamydia Trachomatis at Baseline |
128
168.4%
|
| Negative for Chlamydia Trachomatis at Baseline |
162
213.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | A priori threshold for statistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.74 | |
| Confidence Interval |
(2-Sided) 95% 0.60 to 0.91 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for scant discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.780 |
| Comments | A priori threshold for statistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.87 | |
| Confidence Interval |
(2-Sided) 95% 0.33 to 2.30 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for moderate discharge amount (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.164 |
| Comments | A priori threshold for statistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.00 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 5.33 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for large amount of discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multvariable logistic regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.919 |
| Comments | A priori threshold for statistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.09 | |
| Confidence Interval |
(2-Sided) 95% 0.23 to 5.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.051 |
| Comments | A priori threshold for statistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.81 | |
| Confidence Interval |
(2-Sided) 95% 1.00 to 3.30 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for 1 or more new sex partners in the last 30 days (reference category is 0) is 1 versus the alternative that it is greater than or less than 1. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.076 |
| Comments | A priori threshold for statistical significance was p<0.05 | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 4.42 | |
| Confidence Interval |
(2-Sided) 95% 0.86 to 22.74 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for ever having sex with a prostitute or sex for money, drugs, or other things (reference category is no) is 1 versus the alternative that it is greater than or less than 1. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.075 |
| Comments | A priori threshold fors tatistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.38 | |
| Confidence Interval |
(2-Sided) 95% 0.13 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for visit due to sexually transmitted disease contact (reference category is no) is 1 versus the alternative that it is greater than or less than 1. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | A priori threshold for statistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.92 | |
| Confidence Interval |
(2-Sided) 95% 1.93 to 7.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis |
|---|---|
| Description | Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months. |
| Time Frame | Baseline (enrollment visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All study participants who met major eligibility criteria (per protocol) with evaluable baseline results. |
| Arm/Group Title | All Participants Analyzed |
|---|---|
| Arm/Group Description | |
| Measure Participants | 291 |
| Positive for Trichomonas Vaginalis at Baseline |
38
50%
|
| Negative for Trichomonas Vaginalis at Baseline |
253
332.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | A priori threshold for statistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.20 | |
| Confidence Interval |
(2-Sided) 95% 0.06 to 0.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for ever having sex with a prostitute or for money, drugs, or other things(reference category is no) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.074 |
| Comments | A priori threshold for statistical signficance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.39 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 6.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis |
|---|---|
| Description | Logistic multiple regression with independent variable selection based on single variable models with p<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months. |
| Time Frame | Baseline (enrollment visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All study participants who met major eligibility criteria (per protocol) with evaluable baseline results. |
| Arm/Group Title | All Participants Analyzed |
|---|---|
| Arm/Group Description | |
| Measure Participants | 292 |
| Positive for Mycoplasma Genitalium at Baseline |
90
118.4%
|
| Negative for Mycoplasma Genitalium at Baseline |
202
265.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Doxycycline |
|---|---|---|
| Comments | The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that the odds ratio is greater than or less than 1. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | A priori threshold for statistical significance was p<0.05. | |
| Method | Regression, Logistic | |
| Comments | No other independent variables were included in the model. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 0.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset |
|---|---|
| Description | At all study visits, unsolicited adverse events were recorded. |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 77 | 79 |
| Number [Participants] |
1
1.3%
|
1
1.4%
|
1
1.3%
|
0
0%
|
| Title | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain |
|---|---|
| Description | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 77 | 79 |
| Number [Participants] |
6
7.9%
|
5
6.8%
|
3
3.9%
|
5
6.3%
|
| Title | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea |
|---|---|
| Description | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 77 | 79 |
| Number [Participants] |
0
0%
|
3
4.1%
|
3
3.9%
|
7
8.9%
|
| Title | Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole |
|---|---|
| Description | Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit. Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs). Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs) |
| Time Frame | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent to treat: all subjects randomized who received at least one dose of study drug therapy or placebo |
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole |
|---|---|---|---|---|
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Measure Participants | 76 | 73 | 77 | 79 |
| Number [Percentage of participants] |
47
61.8%
|
51
69.9%
|
39
50.6%
|
48
60.8%
|
| Title | Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis |
|---|---|
| Description | Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis |
| Time Frame | Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were unsolicited. | |||||||
| Arm/Group Title | Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole | ||||
| Arm/Group Description | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). | ||||
All Cause Mortality |
||||||||
| Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/76 (0%) | 0/73 (0%) | 0/77 (0%) | 0/79 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Doxycycline | Doxycycline + Tinidazole | Azithromycin | Azithromycin + Tinidazole | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/76 (23.7%) | 25/73 (34.2%) | 11/77 (14.3%) | 24/79 (30.4%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 6/76 (7.9%) | 6 | 5/73 (6.8%) | 5 | 3/77 (3.9%) | 3 | 5/79 (6.3%) | 5 |
| Constipation | 1/76 (1.3%) | 1 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Diarrhea | 0/76 (0%) | 0 | 3/73 (4.1%) | 3 | 3/77 (3.9%) | 3 | 7/79 (8.9%) | 7 |
| Dry mouth | 1/76 (1.3%) | 1 | 1/73 (1.4%) | 1 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| Dyspepsia | 1/76 (1.3%) | 1 | 1/73 (1.4%) | 1 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| Nausea | 3/76 (3.9%) | 7 | 4/73 (5.5%) | 4 | 0/77 (0%) | 0 | 4/79 (5.1%) | 4 |
| Stomach upset/ stomach discomfort | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 1/77 (1.3%) | 1 | 0/79 (0%) | 0 |
| Vomiting | 4/76 (5.3%) | 4 | 2/73 (2.7%) | 2 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| General disorders | ||||||||
| Bloody discharge | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Fatigue | 0/76 (0%) | 0 | 1/73 (1.4%) | 1 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| Feeling hot | 0/76 (0%) | 0 | 1/73 (1.4%) | 1 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| Pain | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 1/77 (1.3%) | 1 | 0/79 (0%) | 0 |
| Infections and infestations | ||||||||
| Folliculitis | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 1/77 (1.3%) | 1 | 0/79 (0%) | 0 |
| Respiratory infection/ respiratory tract infection | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Sinus infection/ sinusitis | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Urinary tract infection | 0/76 (0%) | 0 | 1/73 (1.4%) | 1 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Limb injury | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Spider bite/ anthropod bite | 0/76 (0%) | 0 | 1/73 (1.4%) | 1 | 1/77 (1.3%) | 1 | 0/79 (0%) | 0 |
| Wrist sprain/ joint sprain | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Nervous system disorders | ||||||||
| Headache | 4/76 (5.3%) | 4 | 4/73 (5.5%) | 4 | 0/77 (0%) | 0 | 2/79 (2.5%) | 3 |
| Light headedness/ dizziness | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 2/79 (2.5%) | 2 |
| Somnolence | 1/76 (1.3%) | 1 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Taste abnormality/ disgeusia | 0/76 (0%) | 0 | 6/73 (8.2%) | 6 | 0/77 (0%) | 0 | 4/79 (5.1%) | 4 |
| Psychiatric disorders | ||||||||
| Insomnia | 1/76 (1.3%) | 1 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Urine abnormality | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 1/77 (1.3%) | 1 | 0/79 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Balanoposthitis | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Erectile dysfunction | 1/76 (1.3%) | 1 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| Genital Herpes | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 1/77 (1.3%) | 1 | 1/79 (1.3%) | 1 |
| Genital lesion | 1/76 (1.3%) | 1 | 1/73 (1.4%) | 1 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Genital pain | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Genital ulceration | 1/76 (1.3%) | 1 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Pruritus genital | 0/76 (0%) | 0 | 1/73 (1.4%) | 1 | 0/77 (0%) | 0 | 0/79 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Blister | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 1/77 (1.3%) | 1 | 0/79 (0%) | 0 |
| Pityriasis Rosea | 0/76 (0%) | 0 | 0/73 (0%) | 0 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
| Rash | 0/76 (0%) | 0 | 1/73 (1.4%) | 1 | 0/77 (0%) | 0 | 1/79 (1.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jane R. Schwebke, MD |
|---|---|
| Organization | University of Alabama at Birmingham |
| Phone | (205) 975-5665 |
| schwebke@uab.edu |
- 05-0120