Phase 2
N=305
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Urethritis
Bottom Line
View on ClinicalTrials.gov: NCT00322465 ↗Enrolled (actual)
305
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea — 3; 4; 0; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tinidazole (Drug); Placebo (Other); Doxycycline (Drug); Azithromycin (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Male
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea |
3; 4; 0; 4 | — |
| PRIMARY Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting |
4; 2; 0; 0 | — |
| PRIMARY Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset |
1; 1; 1; 0 | — |
| PRIMARY Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain |
6; 5; 3; 5 | — |
| PRIMARY Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea |
0; 3; 3; 7 | — |
| PRIMARY Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole |
47; 51; 39; 48 | — |
| SECONDARY Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) |
49; 44 | — |
| SECONDARY Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole |
89; 75; 66; 61 | — |
| SECONDARY Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole |
55; 75; 56; 50 | — |
| SECONDARY Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole |
23; 32; 52; 68 | — |
| SECONDARY Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis |
50; 38; 38; 46 | — |
| SECONDARY Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis |
14; 16; 12; 10 | — |
| SECONDARY Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis |
29; 30; 32; 32 | — |
| SECONDARY Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis |
128; 162 | 0.005 sig |
| SECONDARY Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis |
38; 253 | 0.009 sig |
| SECONDARY Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis |
90; 202 | 0.032 sig |
| SECONDARY Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis |
— | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00322465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.