Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT01825408
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics as part of maximal medical therapy for treating chronic sinusitis and thus preventing patients from having to have sinus surgery. The hypothesis is that in the context of maximal medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at successfully treating chronic sinusitis.

Condition or Disease	Intervention/Treatment	Phase
Sinusitis	Drug: Doxycycline; Drug: Azithromycin; Drug: Augmentin	Phase 4

Detailed Description

OVERVIEW This is a prospective randomized cohort study assessing duration of antibiotics (3 vs 6 weeks) as part of maximal medical therapy for chronic rhinosinusitis. Up to 100 subjects will be prospectively enrolled from patients visiting the Department of Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals.

INITIAL CLINIC VISIT At the time of a clinical visit, the attending otolaryngologists will identify their patients with chronic rhinosinusitis (CRS) who are appropriate for maximal medical treatment, including antibiotics. They will introduce the study to these patients and invite them to learn more about it.

If the patient is interested in learning more about the study, the study coordinators will be contacted to provide additional information and, if the patient would like to participate in the study, provide informed consent.

If the patient is a premenopausal woman, she will be asked if she is pregnant or breastfeeding.

If she is either of these, she will be excluded from the study. All remaining women will receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will be excluded from the study. Thus, for premenopausal female patients, a negative urine pregnancy test is necessary for inclusion in the study. These women will be informed that they should use an effective method of birth control during the study:

• Combined oral contraceptives

• Patch contraceptives

• Vaginal ring contraceptives

• Injectable contraceptives

• Implantable contraceptives

• Intrauterine devices or intrauterine systems

• Tubal ligation

• Barrier methods of contraception (male condom, female condom, cervical cap with spermicide, or diaphragm with spermicide)

• Vasectomy of your partner in a monogamous relationship

Women enrolled in this study will be informed that if they have a failure of birth control method during the course of the study or become pregnant during the study, they will be withdrawn from the study and further treatment will be decided according to the clinical withdrawn from the study and further treatment will be decided according to the clinical expertise of the treating otolaryngologist.

• The study coordinators will assign the patients a unique Subject ID that will be used on all patient forms with the exception of the informed consent documents and HIPAA authorization forms.

• The patient will fill out a demographics and past medical history form.

• Using a random-number generator, the patient will be randomized to receive either 3 or 6 weeks of antibiotics.

• The subject will initially be given a prescription for empiric antibiotics.The choice of empiric antibiotics will differ based on the patient's nasal polyposis status:

• If the subject has CRS with nasal polyposis (CRSwNP), s/he will be given Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for either 3 or 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for CRSwNP.

• If the subject has CRS without Nasal Polyposis (CRSwNP), s/he will be given Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for either 3 or 6 weeks duration.

• If purulent nasal discharge is present that is appropriate for culture, the otolaryngologists will send this for culture and sensitivity analysis, which they would normally do as part of their routine clinical care. The patients will be informed that if their culture and sensitivity analysis indicates that they have an infection that can be treated with a less broad-spectrum antibiotic, then they will be prescribed culture-directed antibiotics. Otherwise, the patient can continue empiric antibiotics as previously specified.

• All study participants will also be prescribed standard of care intranasal steroids, and encouraged to perform BID saline sinus irrigation and use yogurt/over the counter probiotics to reduce GI side effects of antibiotics.

4-5 WEEKS AFTER BEGINNING TREATMENT For subjects randomized to the 3 week antibiotic group, these subjects will been seen in clinic.

During this visit (study visit #2), subjects will be asked about antibiotic compliance and side effects. Recommendation for sinus surgery will be evaluated with video-recorded nasal endoscopy and a sinus CT and made based on clinical judgement.

For subjects randomized to the 6 week antibiotic group, these subjects will be contacted by phone by the study coordinator to assess side effects and medication compliance.

7-8 WEEKS AFTER BEGINNING TREATMENT

For subjects randomized to the 6 week antibiotic group, these subjects will been seen in clinic.

During this visit (study visit #2), subjects will be asked about antibiotic compliance and side effects. Recommendation for sinus surgery will be evaluated with video-recorded nasal endoscopy and a sinus CT and made based on clinical judgement.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Cohort Trial Evaluating Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Doxycycline, 3 weeks Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.	Drug: Doxycycline; Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.; Drug: Augmentin; If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
Active Comparator: Doxycycline, 6 weeks Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.	Drug: Doxycycline; Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.; Drug: Augmentin; If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
Active Comparator: Azithromycin, 3 weeks Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.	Drug: Azithromycin; Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.; Drug: Augmentin; If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
Active Comparator: Azithromycin, 6 weeks Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.	Drug: Azithromycin; Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.; Drug: Augmentin; If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Outcome Measures

Primary Outcome Measures

1. Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy [4-5 weeks after starting antibiotics]

   Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.

2. Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy [7-8 weeks after initiating antibiotics]

   Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of chronic rhinosinusitis

• 18 years of age or older

• English speaking

Exclusion Criteria:

• Pregnant or breastfeeding women

• vasculitis

• cystic fibrosis

• primary ciliary dyskinesia

• allergic fungal sinusitis

• gross immunodeficiency

• current use of chemotherapy

• insulin-dependent diabetes mellitus

• recent trial of maximal medical therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals	Chapel Hill	North Carolina	United States	27514

Sponsors and Collaborators

• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Adam Zanation, MD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adam Zanation, MD, Assistant Professor of Otolaryngology/Head and Neck Surgery, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01825408
• Other Study ID Numbers: 12-2377
• First Posted: Apr 5, 2013
• Last Update Posted: Apr 4, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Sinusitis; Azithromycin; Doxycycline; Amoxicillin-Potassium Clavulanate Combination

Study Results

Participant Flow

Arm/Group Title	Doxycycline, 3 Weeks	Doxycycline, 6 Weeks	Azithromycin, 3 Weeks	Azithromycin, 6 Weeks
Arm/Group Description	Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps. Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps. Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration. Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration. Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
Period Title: Overall Study
STARTED	7	7	14	12
COMPLETED	7	7	14	12
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Doxycycline, 3 Weeks	Doxycycline, 6 Weeks	Azithromycin, 3 Weeks	Azithromycin, 6 Weeks	Total
Arm/Group Description	Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps. Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps. Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration. Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration. Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Total of all reporting groups
Overall Participants	7	7	14	12	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	6 85.7%	7 100%	11 78.6%	9 75%	33 82.5%
>=65 years	1 14.3%	0 0%	3 21.4%	3 25%	7 17.5%
Sex: Female, Male (Count of Participants)
Female	3 42.9%	2 28.6%	8 57.1%	8 66.7%	21 52.5%
Male	4 57.1%	5 71.4%	6 42.9%	4 33.3%	19 47.5%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy
Description	Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.
Time Frame	4-5 weeks after starting antibiotics

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Doxycycline, 3 Weeks	Azithromycin, 3 Weeks
Arm/Group Description	Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps. Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration. Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
Measure Participants	7	14
Sinus Surgery Recommended	7 100%	8 114.3%
Sinus Surgery NOT Recommended	0 0%	6 85.7%

2. Primary Outcome

Title	Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy
Description	Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.
Time Frame	7-8 weeks after initiating antibiotics

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Doxycycline, 6 Weeks	Azithromycin, 6 Weeks
Arm/Group Description	Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps. Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration	Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration. Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
Measure Participants	7	12
Sinus Surgery Recommended	5 71.4%	8 114.3%
Sinus Surgery NOT Recommended	2 28.6%	4 57.1%

Adverse Events

Arm/Group Title	Doxycycline, 3 Weeks		Doxycycline, 6 Weeks		Azithromycin, 3 Weeks		Azithromycin, 6 Weeks
Arm/Group Description	Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps. Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration		Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps. Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration		Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration. Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration		Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration. Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration. Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
All Cause Mortality
	Doxycycline, 3 Weeks		Doxycycline, 6 Weeks		Azithromycin, 3 Weeks		Azithromycin, 6 Weeks
	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, 3 Weeks		Doxycycline, 6 Weeks		Azithromycin, 3 Weeks		Azithromycin, 6 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/14 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Doxycycline, 3 Weeks		Doxycycline, 6 Weeks		Azithromycin, 3 Weeks		Azithromycin, 6 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		1/7 (14.3%)		0/14 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Diarrhea	0/7 (0%)		1/7 (14.3%)		0/14 (0%)		1/12 (8.3%)

Limitations/Caveats

[Not Specified]

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.