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

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 204 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Primary and study completion dates: Apr 2009 to Apr 20, 2009

    Start date: Nov 2006 to Nov 17, 2006; Study sites revised (4)

    Show what changed: Study sites
    Johns Hopkins Hospital - Emergency MedicineDepartment

    Study Status, Oversight, Conditions, Arms and Interventions, Contacts/Locations, Outcome Measures (Results)v204

  2. Minor

    Study Status, Outcome Measures (Results)

    Re-verified, no change to tracked fields

    v203

  3. Minor

    Interventions: Azithromycin (Drug), Doxycycline (Drug), Placebo Azithromycin (Drug), Placebo Doxycycline (Drug), Placebo Tinidazole (Drug), Tinidazole… to Azithromycin (Drug), Doxycycline (Drug), Placebo (Other), Tinidazole (Drug)

    Study sites revised (4)

    Show what changed: Study sites
    University of Alabama atHospital Birmingham- Infectious Diseases Delgado ClinicPersonal Health Center Johns Hopkins Hospital - Emergency Medicine University of North Carolina atSchool Chapelof HillMedicine - Center for Infectious Diseases

    Study Status, Conditions, Arms and Interventions, Contacts/Locations, Baseline Characteristicsv202

  4. Minor

    Eligibility criteria revised

    Study sites revised (4)

    Show what changed: Eligibility criteria
    Inclusion Criteria: - Male, 16 to 45 years old. -Symptoms of non-gonococcal urethritis (NGU), including ureth [...] ss 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 m [...] prior year) or history of recent NGU (within past 30 days). -Signs or sympt [...] [...]
    Show what changed: Study sites
    LouisianaDelgado State UniversityClinic Johns Hopkins UniversityHospital

    Study Status, Sponsor/Collaborators, Conditions, Arms and Interventions, Eligibility, Contacts/Locationsv201

  5. Minor

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    Inclusion Criteria: -Male, 16 to 45 years old. -Symptoms of non-gonococcal urethritis (NGU), including ureth [...] ss 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 m [...] prior year) or history of recent NGU (within past 30 days). -Signs or symptom [...] [...]

    Study Identification, Study Status, Arms and Interventions, Eligibilityv200

Show 45 earlier versions

  1. Notable

    Results first posted: Aug 17, 2011

    Primary endpoints: 2 to 6; Interventions: Azithromycin (Drug), Doxycycline (Drug), Placebo (Drug), Tinidazole (Drug) to Azithromycin (Drug), Doxycycline (Drug), Placebo Azithromycin (Drug), Placebo Doxycycline (Drug), Placebo Tinidazole (Drug), Tinidazole…; Secondary endpoints: 4 to 11; and 1 more

    Show all 5 changes in this update
    • Notable Results first posted: Aug 17, 2011
    • Notable Primary endpoints: 2 to 6
      Show what changed
      Evaluate the safety and tolerabilityPercentage of doxycycline/tinidazoleParticipants andAchieving azithromycin/tinidazoleClinical in the treatmentCure of Non-gonococcal Urethritis (NGU. For) theWith treatmentDoxycycline ofVersus NGU,Doxycycline compareWith the clinical cure rates of doxycycline versus doxycycline with tinidazoleTinidazole; and azithromycinAzithromycin versusVersus azithromycinAzithromycin withWith tinidazole.Tinidazole Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea Safety and Tolerability of Doxycycline/ [...]
    • Minor Interventions: Azithromycin (Drug), Doxycycline (Drug), Placebo (Drug), Tinidazole (Drug) to Azithromycin (Drug), Doxycycline (Drug), Placebo Azithromycin (Drug), Placebo Doxycycline (Drug), Placebo Tinidazole (Drug), Tinidazole…
    • Minor Secondary endpoints: 4 to 11
      Show what changed
      Percentage of Participants Achieving Clinical cureCure ratesof NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole Percen [...] , analysisBehavioral, willand alsoDemographic include:Predictors (doxycyclineof plusChlamydia doxycycline/tinidazole)Trachomatis versusin (azithromycinMen plusWith azithromycin/tinidazole).Non-gonococcal Urethritis CollectClinical, specimen [...] [...]
    • Minor Study description expanded, about 3 words
      Show what changed
      [...] efficacious for NGU as it is more effective in eradicating Mycoplasma (M.) genitalium from the genital tract than the former. Only in [...] in at least certain populations due to lack of coverage for Trichomonas (T.) vaginalis. The researchers further hypothesize that between [...] y study objectives are to: evaluate microbiological cure of Chlamydia (C.) trachomatis, T. vaginalis, M. genitalium in men treated wit [...]

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, References, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Eventsv199

  2. Minor

    5 amendments

    5 re-verifications since 2010-01-07, no change to tracked fields

    v194-v198

  3. Minor

    Secondary endpoints reordered

    Study Status, Conditions, Arms and Interventions, Outcome Measuresv193

  4. Minor

    Secondary endpoints reordered

    Study Status, Conditions, Arms and Interventions, Outcome Measuresv192

  5. Minor

    2 amendments

    2 re-verifications since 2009-12-03, no change to tracked fields

    v190-v191

  6. Minor

    Primary and study completion dates: May 2009 to Apr 2009

    Study Statusv189

  7. Minor

    Secondary endpoints reordered

    Study Status, Arms and Interventions, Outcome Measuresv188

  8. Minor

    6 amendments

    6 re-verifications since 2009-10-08, no change to tracked fields

    v182-v187

  9. Minor

    Secondary endpoints reordered

    Study Status, Conditions, Arms and Interventions, Outcome Measuresv181

  10. Minor

    Study Status, Arms and Interventions

    Re-verified, no change to tracked fields

    v180

  11. Minor

    Secondary endpoints reordered

    Study Status, Arms and Interventions, Outcome Measuresv179

  12. Minor

    Secondary endpoints reordered

    Study Status, Arms and Interventions, Outcome Measuresv178

  13. Minor

    Secondary endpoints reordered

    Study Status, Arms and Interventions, Outcome Measuresv177

  14. Minor

    Secondary endpoints reordered

    Study Status, Arms and Interventions, Outcome Measuresv176

  15. Minor

    6 amendments

    6 re-verifications since 2009-07-16, no change to tracked fields

    v170-v175

  16. Minor

    Secondary endpoints reordered

    Study Status, Outcome Measuresv169

  17. Minor

    Study Status, Arms and Interventions

    Re-verified, no change to tracked fields

    v168

  18. Minor

    Trial status: Active, Not Recruiting to Completed

    Study Status, Arms and Interventionsv167

  19. Minor

    2 amendments

    2 re-verifications since 2009-06-11, no change to tracked fields

    v165-v166

  20. Minor

    Secondary endpoints reordered

    Study Status, Outcome Measuresv164

  21. Minor

    Study Status

    Re-verified, no change to tracked fields

    v163

  22. Minor

    Secondary endpoints reordered

    Study Status, Arms and Interventions, Outcome Measuresv162

  23. Minor

    4 amendments

    4 re-verifications since 2009-05-01, no change to tracked fields

    v158-v161

  24. Minor

    Secondary endpoints reordered

    Study Status, Arms and Interventions, Outcome Measuresv157

  25. Minor

    Study Status

    Re-verified, no change to tracked fields

    v156

  26. Minor

    Primary and study completion dates: Nov 2009 to May 2009

    Study Statusv155

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00322465
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Urethritis
Enrollment 305 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov