Cefixime for Alternative Syphilis Treatment
Study Details
Study Description
Brief Summary
The goal of the study is to evaluate the efficacy of oral cefixime as an alternative treatment for syphilis infection.
One hundred adult patients (≥18 years old) with syphilis infection (positive Treponema Pallidum Particle Agglutination assay and RPR titer ≥ 1/8) will be recruited. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime.
During the study, participants will visit the clinic up to 5 times; at baseline visit, at 3, 6, 12 months after treatment initiation. Participants of the cefixime group will be required to visit the clinic 14 days after treatment initiation. In each visit, participants will be asked about current symptoms and do laboratory tests for syphilis (RPR). Subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 6 months will be considered a positive treatment response.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Syphilis is a major issue worldwide causing 5.6 million new cases of syphilis worldwide, of which over 900,000 are pregnant women. It is also responsible for congenital infections causing fetal loss or stillbirth or, in a live-born infant, neonatal death, prematurity and low birth weight. Penicillin is the currently used treatment. However, lack of penicillin and alternatives to treatment often hinder treatment and prevention efforts.
Cefixime is an FDA-approved, orally administered third-generation cephalosporin that is currently used for the treatment of a wide range of infections, including urinary tract infections. Our goal is to evaluate the efficacy and safety of oral cefixime as an alternative treatment for syphilis infection.
One hundred adult patients (≥18 years old) with syphilis infection will be recruited. Eligible participants will have laboratory-confirmed syphilis infection with a positive Treponema pallidum Particle Agglutination (TPPA) assay and RPR (Rapid Plasma Reagin ) titer ≥ 1/8. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime.
During the study, participants will visit the clinic 5 times; at baseline visit, demographic, clinical information and laboratory test results for syphilis will be recorded and treatment will start. Depending on the study group, the treatment plan will be oral Cefixime 400mg, twice per day for ten consecutive days or one dose of intramuscular Penicillin. Patients will be required to visit the clinic two weeks after treatment initiation to verify adverse effects. Follow up visits will occur at 3, 6 and 12 months after treatment initiation. In each visit, participants will be asked about current symptoms, interval sexual history, concomitant antibiotic use and possible adverse reactions. Subjects will also have a venipuncture blood specimen collected for syphilis testing (RPR). Subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 6 months will be considered a positive treatment response.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Benzathine Penicillin G Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients. |
Drug: Benzathine Penicillin G
The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection
|
Experimental: Cefixime Group Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication. The group will consist of 50 patients. |
Drug: Cefixime 400 milligram Oral Capsule [Suprax]
The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Treatment Response [3 or 6 months after treatment completion]
subjects who have a 4-fold decrease (from study entry Rapid plasma reagin) in Rapid plasma reagintiters from baseline at 3 or 6 months will be considered a positive treatment response.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or older and able to provide informed consent
-
Cases of primary, secondary or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment.
-
HIV infected individuals willing to participate in the study must have CD4 count ≥350 cells/μl within the last 4 weeks and be virally suppressed (i.e., viral load ≤ 200 copies/mL) for HIV for the 6 months prior to enrolment with the most recent results within the last 4 weeks. inclusion
-
Non-cephalosporin allergic
-
Able to travel to the clinic once a day or be available for phone calls or receive text messages for at least 7-10 days and willing to attend follow-up visits
-
Able to swallow pills
Exclusion Criteria:
-
Pregnancy or positive pregnancy test
-
Serofast RPR titer (prior titer 1:8 or greater)
-
Recent (less than 7 days) or concomitant antimicrobial therapy with activity against syphilis.
-
Cephalosporin allergy: previous episode of flushing, urticaria, angioedema, rhinitis, bronchospasm, and anaphylactic shock, rash after taking cephalosporin.
-
Penicillin allergy: previous episode of flushing, urticaria, angioedema, rhinitis, bronchospasm, and anaphylactic shock, rash after receiving Penicillin.
-
Has a medical condition or other factor that might affect their ability to follow the protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | AHF Westside | Beverly Hills | California | United States | 90211 |
2 | AHF Downtown Healthcare Center | Los Angeles | California | United States | 90015 |
3 | AHF Carl Bean | Los Angeles | California | United States | 90018 |
4 | AHF Hollywood Healthcare Center | Los Angeles | California | United States | 90027 |
5 | AHF Wellness on Western Center | Los Angeles | California | United States | 90027 |
6 | AHF Oakland Wellness Center | Oakland | California | United States | 94606 |
7 | AHF Healthcare Center Oakland | Oakland | California | United States | 94609 |
8 | AHF San Francisco | San Francisco | California | United States | 94114 |
9 | AHF Valley | Sherman Oaks | California | United States | 91403 |
10 | AHF Las Vegas Healthcare Center | Las Vegas | Nevada | United States | 89109 |
Sponsors and Collaborators
- University of California, Los Angeles
- AIDS Healthcare Foundation
Investigators
- Principal Investigator: Jeffrey D Klausner, MD MPH, University of California, Los Angeles
- Principal Investigator: David Tellalian, MD, AIDS Helthcare Foundation
Study Documents (Full-Text)
More Information
Publications
None provided.- 18-000665
- 20181796
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Benzathine Penicillin G | Cefixime Group |
---|---|---|
Arm/Group Description | Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients. Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection | Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication. The group will consist of 50 patients. Cefixime 400 milligram Oral Capsule [Suprax]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days |
Period Title: Overall Study | ||
STARTED | 31 | 27 |
COMPLETED | 31 | 27 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Benzathine Penicillin G | Cefixime Group | Total |
---|---|---|---|
Arm/Group Description | Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients. Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection | Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication. The group will consist of 50 patients. Cefixime 400 milligram Oral Capsule [Suprax]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days | Total of all reporting groups |
Overall Participants | 31 | 27 | 58 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
31
100%
|
26
96.3%
|
57
98.3%
|
>=65 years |
0
0%
|
1
3.7%
|
1
1.7%
|
Age (years) [Median (Inter-Quartile Range) ] | |||
Median (Inter-Quartile Range) [years] |
39
|
39
|
39
|
Sex: Female, Male (Count of Participants) | |||
Female |
0
0%
|
0
0%
|
0
0%
|
Male |
31
100%
|
27
100%
|
58
100%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
19
61.3%
|
18
66.7%
|
37
63.8%
|
Not Hispanic or Latino |
12
38.7%
|
9
33.3%
|
21
36.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Hispanic/Latinx, or Spanish Origin |
19
61.3%
|
18
66.7%
|
37
63.8%
|
Non-Hispanic African American |
5
16.1%
|
4
14.8%
|
9
15.5%
|
Non-Hispanic White |
6
19.4%
|
4
14.8%
|
10
17.2%
|
Non-Hispanic Asian/Hawaiian/Pacific Islander |
1
3.2%
|
1
3.7%
|
2
3.4%
|
Region of Enrollment (Count of Participants) | |||
United States |
31
100%
|
27
100%
|
58
100%
|
Outcome Measures
Title | Treatment Response |
---|---|
Description | subjects who have a 4-fold decrease (from study entry Rapid plasma reagin) in Rapid plasma reagintiters from baseline at 3 or 6 months will be considered a positive treatment response. |
Time Frame | 3 or 6 months after treatment completion |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Benzathine Penicillin G | Cefixime Group |
---|---|---|
Arm/Group Description | Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients. Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection | Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication. The group will consist of 50 patients. Cefixime 400 milligram Oral Capsule [Suprax]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days |
Measure Participants | 15 | 15 |
Count of Participants [Participants] |
14
45.2%
|
13
48.1%
|
Adverse Events
Time Frame | Adverse event data were collected throughout the duration of the study (12 months) starting from enrollment. Evaluation for adverse events occurred during follow ups; for the cefixime group we evaluated adverse events during the 10-day visit. Participants and study clinicians were instructed to report any occurrence to the study team for review. | |||
---|---|---|---|---|
Adverse Event Reporting Description | In case of an adverse event, participants were instructed to contact the study team. The team had provided necessary clinic and study team contact informaion | |||
Arm/Group Title | Benzathine Penicillin G | Cefixime Group | ||
Arm/Group Description | Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients. Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection | Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication. The group will consist of 50 patients. Cefixime 400 milligram Oral Capsule [Suprax]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days | ||
All Cause Mortality |
||||
Benzathine Penicillin G | Cefixime Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/31 (0%) | 0/27 (0%) | ||
Serious Adverse Events |
||||
Benzathine Penicillin G | Cefixime Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/31 (0%) | 1/27 (3.7%) | ||
Skin and subcutaneous tissue disorders | ||||
Mild Skin Rash | /31 (NaN) | 1/27 (3.7%) | 1 | |
Other (Not Including Serious) Adverse Events |
||||
Benzathine Penicillin G | Cefixime Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/31 (0%) | 0/27 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Jeffrey D Klausner MD MPH, Clinical Professor of Population and Public Health Sciences |
---|---|
Organization | University of Southern California |
Phone | 4158768901 |
jdklausner@med.usc.edu |
- 18-000665
- 20181796