NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00322465
• Date of registration: 04/05/2006
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
• Scientific 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)
• Date of first enrolment: November 2006
• Target sample size: 305
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00322465
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

C Trachomatis

M Genitalium

Non-Gonococcal Urethritis

T Vaginalis

Urethritis

Intervention(s)

Drug: Azithromycin

Drug: Doxycycline

Drug: Placebo Azithromycin

Drug: Placebo Doxycycline

Drug: Placebo Tinidazole

Drug: Tinidazole

Primary Outcome(s)

Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Secondary Outcome(s)

Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis [Time Frame: Baseline (enrollment visit)]

Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis [Time Frame: Baseline (enrollment visit)]

Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis [Time Frame: Baseline (enrollment visit)]

Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole [Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)]

Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis [Time Frame: Baseline (enrollment visit)]

Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis [Time Frame: Baseline (enrollment)]

Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis [Time Frame: Baseline (enrollment visit)]

Specimens 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)]

Secondary ID(s)

05-0120

Source(s) of Monetary Support

Please refer to primary and secondary sponsors