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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline | Experimental | Doxycycline 100 mg orally twice daily (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin orally single dose and placebo tinidazole. |
|
| Doxycycline + Tinidazole | Experimental | 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). |
|
| Azithromycin | Experimental | 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. |
|
| Azithromycin + Tinidazole | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinidazole | Drug | 2 gm single dose (4 tablets orally at 500 mg each). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). | 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 | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). | 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 | At all study visits, unsolicited adverse events were recorded. | 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 | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). | 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 | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/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 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Hospital - Infectious Diseases | Birmingham | Alabama | 35249-0001 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21288838 | Result | Schwebke JR, Rompalo A, Taylor S, Sena AC, Martin DH, Lopez LM, Lensing S, Lee JY. Re-evaluating the treatment of nongonococcal urethritis: emphasizing emerging pathogens--a randomized clinical trial. Clin Infect Dis. 2011 Jan 15;52(2):163-70. doi: 10.1093/cid/ciq074. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. |
| FG001 | Doxycycline + Tinidazole | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). |
| FG002 | Azithromycin | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. |
| FG003 | Azithromycin + Tinidazole | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. |
| BG001 | Doxycycline + Tinidazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Posted | Number | Participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
Trial involved an enrollment visit, first follow-up visit (Day 15-19), and second follow-up visit (Day 35-45). Timeframe was approximately 7 weeks.
Adverse events were unsolicited.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxycycline | Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane R. Schwebke, MD | University of Alabama at Birmingham | (205) 975-5665 | schwebke@uab.edu |
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| ID | Term |
|---|---|
| D014526 | Urethritis |
| ID | Term |
|---|---|
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D014011 | Tinidazole |
| D004318 | Doxycycline |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Placebo | Other | Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline. |
|
| Doxycycline | Drug | 100 mg orally, twice daily for 7 days. |
|
| Azithromycin | Drug | 1 gram (gm) (2 tablets orally at 500 milligrams (mg) each). |
|
| First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
| Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With 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) | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
| 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 | Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline. | 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 | Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen). | 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 | Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline. | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
| Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis | Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment) | Baseline (enrollment visit) |
| Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis | Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment) | Baseline (enrollment visit) |
| Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis | Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment) | Baseline (enrollment) |
| Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis | Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months. | Baseline (enrollment visit) |
| Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis | Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months. | Baseline (enrollment visit) |
| Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis | Logistic multiple regression with independent variable selection based on single variable models with p<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months. | Baseline (enrollment visit) |
| Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis | Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis | Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
| Delgado Personal Health Center |
| New Orleans |
| Louisiana |
| 70112-3503 |
| United States |
| Johns Hopkins Hospital - Emergency Medicine | Baltimore | Maryland | 21287-0005 | United States |
| University of North Carolina School of Medicine - Center for Infectious Diseases | Chapel Hill | North Carolina | 27599-7030 | United States |
Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
| BG002 | Azithromycin | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. |
| BG003 | Azithromycin + Tinidazole | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Doxycycline + Tinidazole |
Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). |
| OG002 | Azithromycin | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. |
| OG003 | Azithromycin + Tinidazole | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). |
|
|
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Posted | Number | Participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Secondary | Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/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 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) | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Posted | Number | Percentage of participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Secondary | Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline. | Participants who were positive at baseline, returned for follow-up, and had evaluable test results. | Posted | Number | Percentage of participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Secondary | Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen). | Participants who were positive at baseline, returned for follow-up, and had evaluable test results. | Posted | Number | Percentage of participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Secondary | Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline. | Participants who were positive at baseline, returned for follow-up, and had evaluable test results. | Posted | Number | Percentage of participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Secondary | Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis | Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment) | All study participants with evaluable baseline test results. | Posted | Number | Percentage of participants | Baseline (enrollment visit) |
|
|
|
| Secondary | Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis | Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment) | All study participants with evaluable baseline test results. | Posted | Number | Percentage of participants | Baseline (enrollment visit) |
|
|
|
| Secondary | Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis | Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment) | All study participants with evaluable baseline test results. | Posted | Number | Percentage of participants | Baseline (enrollment) |
|
|
|
| Secondary | Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis | Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months. | All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures. | Posted | Number | Participants | Baseline (enrollment visit) |
|
|
|
|
| Secondary | Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis | Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months. | All study participants who met major eligibility criteria (per protocol) with evaluable baseline results. | Posted | Number | Participants | Baseline (enrollment visit) |
|
|
|
|
| Secondary | Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis | Logistic multiple regression with independent variable selection based on single variable models with p<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months. | All study participants who met major eligibility criteria (per protocol) with evaluable baseline results. | Posted | Number | Participants | Baseline (enrollment visit) |
|
|
|
|
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset | At all study visits, unsolicited adverse events were recorded. | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Posted | Number | Participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Posted | Number | Participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea | At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0). | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Posted | Number | Participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Primary | Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With 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) | Modified intent to treat: all subjects randomized who received at least one dose of study drug therapy or placebo | Posted | Number | Percentage of participants | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) |
|
|
|
| Secondary | Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis | Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis | Not Posted | Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Participants |
| 0 |
| 76 |
| 18 |
| 76 |
| EG001 | Doxycycline + Tinidazole | Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each). | 0 | 73 | 25 | 73 |
| EG002 | Azithromycin | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose. | 0 | 77 | 11 | 77 |
| EG003 | Azithromycin + Tinidazole | Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each). | 0 | 79 | 24 | 79 |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Bloody discharge | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Genital Herpes | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Genital lesion | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Genital pain | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Genital ulceration | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Light headedness/ dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pityriasis Rosea | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Respiratory infection/ respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Sinus infection/ sinusitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Spider bite/ anthropod bite | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Stomach upset/ stomach discomfort | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Taste abnormality/ disgeusia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Urine abnormality | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Wrist sprain/ joint sprain | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| The null hypothesis is that the odds ratio for scant discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model. | Regression, Logistic | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | 0.780 | A priori threshold for statistical significance was p<0.05. | Odds Ratio (OR) | 0.87 | 2-Sided | 95 | 0.33 | 2.30 | Superiority or Other |
| The null hypothesis is that the odds ratio for moderate discharge amount (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model. | Regression, Logistic | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | 0.164 | A priori threshold for statistical significance was p<0.05. | Odds Ratio (OR) | 2.00 | 2-Sided | 95 | 0.75 | 5.33 | Superiority or Other |
| The null hypothesis is that the odds ratio for large amount of discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multvariable logistic regression model. | Regression, Logistic | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | 0.919 | A priori threshold for statistical significance was p<0.05. | Odds Ratio (OR) | 1.09 | 2-Sided | 95 | 0.23 | 5.17 | Superiority or Other |
| The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. | Regression, Logistic | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | 0.051 | A priori threshold for statistical significance was p<0.05. | Odds Ratio (OR) | 1.81 | 2-Sided | 95 | 1.00 | 3.30 | Superiority or Other |
| The null hypothesis is that the odds ratio for 1 or more new sex partners in the last 30 days (reference category is 0) is 1 versus the alternative that it is greater than or less than 1. | Regression, Logistic | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | 0.076 | A priori threshold for statistical significance was p<0.05 | Odds Ratio (OR) | 4.42 | 2-Sided | 95 | 0.86 | 22.74 | Superiority or Other |
| The null hypothesis is that the odds ratio for ever having sex with a prostitute or sex for money, drugs, or other things (reference category is no) is 1 versus the alternative that it is greater than or less than 1. | Regression, Logistic | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | 0.075 | A priori threshold fors tatistical significance was p<0.05. | Odds Ratio (OR) | 0.38 | 2-Sided | 95 | 0.13 | 1.10 | Superiority or Other |
| The null hypothesis is that the odds ratio for visit due to sexually transmitted disease contact (reference category is no) is 1 versus the alternative that it is greater than or less than 1. | Regression, Logistic | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | <0.001 | A priori threshold for statistical significance was p<0.05. | Odds Ratio (OR) | 3.92 | 2-Sided | 95 | 1.93 | 7.98 | Superiority or Other |
| The null hypothesis is that the odds ratio for ever having sex with a prostitute or for money, drugs, or other things(reference category is no) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model. | Regression, Logistic | Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections. | 0.074 | A priori threshold for statistical signficance was p<0.05. | Odds Ratio (OR) | 2.39 | 2-Sided | 95 | 0.92 | 6.22 | Superiority or Other |