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NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
This study has been completed.
Study NCT00322465   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

First Received on May 4, 2006.   Last Updated on November 10, 2011   History of Changes
Results First Received: June 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: C Trachomatis
M Genitalium
Non-Gonococcal Urethritis
T Vaginalis
Urethritis
Interventions: Drug: Doxycycline
Drug: Placebo Tinidazole
Drug: Placebo Doxycycline
Drug: Placebo Azithromycin
Drug: Tinidazole
Drug: Azithromycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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).
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.
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).

Participant Flow:   Overall Study
    Doxycycline     Doxycycline + Tinidazole     Azithromycin     Azithromycin + Tinidazole  
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



  Baseline Characteristics
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Reporting Groups
  Description
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.
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).
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.
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).

Baseline Measures
    Doxycycline     Doxycycline + Tinidazole     Azithromycin     Azithromycin + Tinidazole     Total  
Number of Participants  
[units: participants]
 		  76     73     77     79     305  
Age  
[units: participants]
 		         
<=18 years     1     1     2     3     7  
Between 18 and 65 years     75     72     75     76     298  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  27.3  ± 7.0     27.8  ± 6.8     26.4  ± 6.7     25.7  ± 7.2     26.8  ± 6.9  
Gender  
[units: participants]
 		         
Female     0     0     0     0     0  
Male     76     73     77     79     305  
Region of Enrollment  
[units: participants]
 		         
United States     76     73     77     79     305  



  Outcome Measures
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1.  Primary:   Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 1

2.  Primary:   Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 2

3.  Primary:   Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 3

4.  Primary:   Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 4

5.  Primary:   Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 5

6.  Primary:   Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole)   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole   [ Time Frame: First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
  Show Outcome Measure 10

11.  Secondary:   Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis   [ Time Frame: Baseline (enrollment visit) ]
  Show Outcome Measure 11

12.  Secondary:   Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis   [ Time Frame: Baseline (enrollment visit) ]
  Show Outcome Measure 12

13.  Secondary:   Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis   [ Time Frame: Baseline (enrollment) ]
  Show Outcome Measure 13

14.  Secondary:   Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis   [ Time Frame: Baseline (enrollment visit) ]
  Show Outcome Measure 14

15.  Secondary:   Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis   [ Time Frame: Baseline (enrollment visit) ]
  Show Outcome Measure 15

16.  Secondary:   Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis   [ Time Frame: Baseline (enrollment visit) ]
  Show Outcome Measure 16

17.  Secondary:   Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis   [ Time Frame: Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jane R. Schwebke, MD
Organization: University of Alabama at Birmingham
phone: (205) 975-5665
e-mail: schwebke@uab.edu


Publications of Results:
Schwebke JR, Rompalo A, Taylor S, Seña 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.


Responsible Party: Director ORA, HHS/NIAID/DMID
ClinicalTrials.gov Identifier: NCT00322465     History of Changes
Other Study ID Numbers: 05-0120
Study First Received: May 4, 2006
Results First Received: June 17, 2010
Last Updated: November 10, 2011
Health Authority: United States: Federal Government;   United States: Food and Drug Administration;   United States: Institutional Review Board





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