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Trial record 87 of 1927 for:    Sexually Transmitted Diseases | NIH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00322465
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : August 17, 2011
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Urethritis
Interventions Drug: Tinidazole
Other: Placebo
Drug: Doxycycline
Drug: Azithromycin
Enrollment 305
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description 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. 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). 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. 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).
Period Title: Overall Study
Started 76 [1] 73 [1] 77 [1] 79 [1]
Completed 56 [2] 49 [2] 51 [2] 53 [2]
Not Completed 20 24 26 26
[1]
Randomized
[2]
Second follow-up visit or clinical failure at first follow-up visit
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole Total
Hide Arm/Group Description 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. 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). 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. 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). Total of all reporting groups
Overall Number of Baseline Participants 76 73 77 79 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 73 participants 77 participants 79 participants 305 participants
<=18 years
1
   1.3%
1
   1.4%
2
   2.6%
3
   3.8%
7
   2.3%
Between 18 and 65 years
75
  98.7%
72
  98.6%
75
  97.4%
76
  96.2%
298
  97.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 73 participants 77 participants 79 participants 305 participants
27.3  (7.0) 27.8  (6.8) 26.4  (6.7) 25.7  (7.2) 26.8  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 73 participants 77 participants 79 participants 305 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
76
 100.0%
73
 100.0%
77
 100.0%
79
 100.0%
305
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 73 participants 77 participants 79 participants 305 participants
76 73 77 79 305
1.Primary Outcome
Title Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea
Hide Description 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).
Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 77 79
Measure Type: Number
Unit of Measure: Participants
3 4 0 4
2.Primary Outcome
Title Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting
Hide Description 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).
Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 77 79
Measure Type: Number
Unit of Measure: Participants
4 2 0 0
3.Primary Outcome
Title Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset
Hide Description At all study visits, unsolicited adverse events were recorded.
Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 77 79
Measure Type: Number
Unit of Measure: Participants
1 1 1 0
4.Primary Outcome
Title Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain
Hide Description 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).
Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 77 79
Measure Type: Number
Unit of Measure: Participants
6 5 3 5
5.Primary Outcome
Title Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea
Hide Description 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).
Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 77 79
Measure Type: Number
Unit of Measure: Participants
0 3 3 7
6.Primary Outcome
Title Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole
Hide Description

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)

Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat: all subjects randomized who received at least one dose of study drug therapy or placebo
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 77 79
Measure Type: Number
Unit of Measure: Percentage of participants
47 51 39 48
7.Secondary Outcome
Title Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole)
Hide Description

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)

Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo
Arm/Group Title Doxycycline + (Doxycycline + Tinidazole) Azithromycin + (Azithromycin + Tinidazole)
Hide Arm/Group Description:
Doxycycline 100 mg PO BID (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin PO single dose and placebo tinidazole + (Doxycycline 100 mg PO BID for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm PO single dose (4 tablets at 500 mg each)).
Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
Overall Number of Participants Analyzed 149 156
Measure Type: Number
Unit of Measure: Percentage of participants
49 44
8.Secondary Outcome
Title Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole
Hide Description 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.
Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were positive at baseline, returned for follow-up, and had evaluable test results.
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 34 24 26 25
Measure Type: Number
Unit of Measure: Percentage of participants
89 75 66 61
9.Secondary Outcome
Title Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole
Hide Description 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).
Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were positive at baseline, returned for follow-up, and had evaluable test results.
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 9 9 7 5
Measure Type: Number
Unit of Measure: Percentage of participants
55 75 56 50
10.Secondary Outcome
Title Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole
Hide Description 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.
Time Frame First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were positive at baseline, returned for follow-up, and had evaluable test results.
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 21 18 22 23
Measure Type: Number
Unit of Measure: Percentage of participants
23 32 52 68
11.Secondary Outcome
Title Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis
Hide Description Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment)
Time Frame Baseline (enrollment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants with evaluable baseline test results.
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 77 79
Measure Type: Number
Unit of Measure: Percentage of participants
50 38 38 46
12.Secondary Outcome
Title Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis
Hide Description 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)
Time Frame Baseline (enrollment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants with evaluable baseline test results.
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 77 79
Measure Type: Number
Unit of Measure: Percentage of participants
14 16 12 10
13.Secondary Outcome
Title Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis
Hide Description Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment)
Time Frame Baseline (enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants with evaluable baseline test results.
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description:
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.
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).
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.
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).
Overall Number of Participants Analyzed 76 73 76 79
Measure Type: Number
Unit of Measure: Percentage of participants
29 30 32 32
14.Secondary Outcome
Title Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis
Hide Description 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.
Time Frame Baseline (enrollment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures.
Arm/Group Title All Participants Analyzed
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 290
Measure Type: Number
Unit of Measure: Participants
Positive for Chlamydia Trachomatis at Baseline 128
Negative for Chlamydia Trachomatis at Baseline 162
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments A priori threshold for statistical significance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.60 to 0.91
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments A priori threshold for statistical significance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.33 to 2.30
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments A priori threshold for statistical significance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.00
Confidence Interval (2-Sided) 95%
0.75 to 5.33
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.919
Comments A priori threshold for statistical significance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.23 to 5.17
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments A priori threshold for statistical significance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
1.00 to 3.30
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments A priori threshold for statistical significance was p<0.05
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.42
Confidence Interval (2-Sided) 95%
0.86 to 22.74
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments A priori threshold fors tatistical significance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.13 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A priori threshold for statistical significance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.92
Confidence Interval (2-Sided) 95%
1.93 to 7.98
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis
Hide Description 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.
Time Frame Baseline (enrollment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.
Arm/Group Title All Participants Analyzed
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 291
Measure Type: Number
Unit of Measure: Participants
Positive for Trichomonas Vaginalis at Baseline 38
Negative for Trichomonas Vaginalis at Baseline 253
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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. This was tested in a multivariable logistic regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments A priori threshold for statistical significance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
0.06 to 0.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments A priori threshold for statistical signficance was p<0.05.
Method Regression, Logistic
Comments Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.39
Confidence Interval (2-Sided) 95%
0.92 to 6.22
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis
Hide Description 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.
Time Frame Baseline (enrollment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.
Arm/Group Title All Participants Analyzed
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 292
Measure Type: Number
Unit of Measure: Participants
Positive for Mycoplasma Genitalium at Baseline 90
Negative for Mycoplasma Genitalium at Baseline 202
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants Analyzed
Comments The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that the odds ratio is greater than or less than 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments A priori threshold for statistical significance was p<0.05.
Method Regression, Logistic
Comments No other independent variables were included in the model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.66 to 0.98
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis
Hide Description 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
Time Frame Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)
Outcome Measure Data Not Reported
Time Frame 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 Event Reporting Description Adverse events were unsolicited.
 
Arm/Group Title Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Hide Arm/Group Description 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. 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). 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. 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).
All-Cause Mortality
Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/76 (0.00%)      0/73 (0.00%)      0/77 (0.00%)      0/79 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxycycline Doxycycline + Tinidazole Azithromycin Azithromycin + Tinidazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/76 (23.68%)      25/73 (34.25%)      11/77 (14.29%)      24/79 (30.38%)    
Gastrointestinal disorders         
Abdominal pain * 1  6/76 (7.89%)  6 5/73 (6.85%)  5 3/77 (3.90%)  3 5/79 (6.33%)  5
Constipation * 1  1/76 (1.32%)  1 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Diarrhea * 1  0/76 (0.00%)  0 3/73 (4.11%)  3 3/77 (3.90%)  3 7/79 (8.86%)  7
Dry mouth * 1  1/76 (1.32%)  1 1/73 (1.37%)  1 0/77 (0.00%)  0 0/79 (0.00%)  0
Dyspepsia * 1  1/76 (1.32%)  1 1/73 (1.37%)  1 0/77 (0.00%)  0 0/79 (0.00%)  0
Nausea * 1  3/76 (3.95%)  7 4/73 (5.48%)  4 0/77 (0.00%)  0 4/79 (5.06%)  4
Stomach upset/ stomach discomfort * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 1/77 (1.30%)  1 0/79 (0.00%)  0
Vomiting * 1  4/76 (5.26%)  4 2/73 (2.74%)  2 0/77 (0.00%)  0 0/79 (0.00%)  0
General disorders         
Bloody discharge * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Fatigue * 1  0/76 (0.00%)  0 1/73 (1.37%)  1 0/77 (0.00%)  0 0/79 (0.00%)  0
Feeling hot * 1  0/76 (0.00%)  0 1/73 (1.37%)  1 0/77 (0.00%)  0 0/79 (0.00%)  0
Pain * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 1/77 (1.30%)  1 0/79 (0.00%)  0
Infections and infestations         
Folliculitis * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 1/77 (1.30%)  1 0/79 (0.00%)  0
Respiratory infection/ respiratory tract infection * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Sinus infection/ sinusitis * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Urinary tract infection * 1  0/76 (0.00%)  0 1/73 (1.37%)  1 0/77 (0.00%)  0 0/79 (0.00%)  0
Injury, poisoning and procedural complications         
Limb injury * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Spider bite/ anthropod bite * 1  0/76 (0.00%)  0 1/73 (1.37%)  1 1/77 (1.30%)  1 0/79 (0.00%)  0
Wrist sprain/ joint sprain * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Nervous system disorders         
Headache * 1  4/76 (5.26%)  4 4/73 (5.48%)  4 0/77 (0.00%)  0 2/79 (2.53%)  3
Light headedness/ dizziness * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 2/79 (2.53%)  2
Somnolence * 1  1/76 (1.32%)  1 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Taste abnormality/ disgeusia * 1  0/76 (0.00%)  0 6/73 (8.22%)  6 0/77 (0.00%)  0 4/79 (5.06%)  4
Psychiatric disorders         
Insomnia * 1  1/76 (1.32%)  1 0/73 (0.00%)  0 0/77 (0.00%)  0 0/79 (0.00%)  0
Renal and urinary disorders         
Urine abnormality * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 1/77 (1.30%)  1 0/79 (0.00%)  0
Reproductive system and breast disorders         
Balanoposthitis * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Erectile dysfunction * 1  1/76 (1.32%)  1 0/73 (0.00%)  0 0/77 (0.00%)  0 0/79 (0.00%)  0
Genital Herpes * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 1/77 (1.30%)  1 1/79 (1.27%)  1
Genital lesion * 1  1/76 (1.32%)  1 1/73 (1.37%)  1 0/77 (0.00%)  0 1/79 (1.27%)  1
Genital pain * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Genital ulceration * 1  1/76 (1.32%)  1 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Pruritus genital * 1  0/76 (0.00%)  0 1/73 (1.37%)  1 0/77 (0.00%)  0 0/79 (0.00%)  0
Skin and subcutaneous tissue disorders         
Blister * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 1/77 (1.30%)  1 0/79 (0.00%)  0
Pityriasis Rosea * 1  0/76 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0 1/79 (1.27%)  1
Rash * 1  0/76 (0.00%)  0 1/73 (1.37%)  1 0/77 (0.00%)  0 1/79 (1.27%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jane R. Schwebke, MD
Organization: University of Alabama at Birmingham
Phone: (205) 975-5665
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00322465     History of Changes
Other Study ID Numbers: 05-0120
First Submitted: May 4, 2006
First Posted: May 8, 2006
Results First Submitted: June 17, 2010
Results First Posted: August 17, 2011
Last Update Posted: March 1, 2019