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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00322465 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
C Trachomatis M Genitalium Non-Gonococcal Urethritis T Vaginalis Urethritis |
Drug: Doxycycline Drug: Placebo Tinidazole Drug: Placebo Doxycycline Drug: Placebo Azithromycin Drug: Tinidazole Drug: Azithromycin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Randomized, Placebo-Controlled Double-Blind 4-Arm Trial for the Treatment of Non-Gonococcal Urethritis (NGU): Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole) |
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)
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)
| Enrollment: | 305 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Doxycycline
100 mg orally, twice daily for 7 days.
Drug: Placebo Tinidazole
Placebo Tinidazole tablet.
Drug: Placebo Azithromycin
Placebo Azithromycin tablet.
|
|
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.
|
Drug: Placebo Tinidazole
Placebo Tinidazole tablet.
Drug: Placebo Doxycycline
Placebo Doxycycline tablet.
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: Placebo Doxycycline
Placebo Doxycycline tablet.
Drug: Tinidazole
2 gm single dose (4 tablets orally at 500 mg each).
Drug: Azithromycin
1 gram (gm) (2 tablets orally at 500 milligrams (mg) each).
|
|
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: Doxycycline
100 mg orally, twice daily for 7 days.
Drug: Placebo Azithromycin
Placebo Azithromycin tablet.
Drug: Tinidazole
2 gm single dose (4 tablets orally at 500 mg each).
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Louisiana | |
| Louisiana State University | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7030 | |
More Information
| Responsible Party: | Director ORA, HHS/NIAID/DMID |
| ClinicalTrials.gov Identifier: | NCT00322465 History of Changes |
| Other Study ID Numbers: | 05-0120 |
| Study First Received: | May 4, 2006 |
| Results First Received: | June 17, 2010 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
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non-gonococcal urethritis, doxycycline, azithromycin, sexually transmitted, tinidazole |
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Urethritis Urethral Diseases Urologic Diseases Doxycycline Doxycycline hyclate Azithromycin Tinidazole Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Alkylating Agents Molecular Mechanisms of Pharmacological Action Antitrichomonal Agents |
