Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00980148
First received: September 17, 2009
Last updated: March 5, 2015
Last verified: June 2014
Results First Received: March 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chlamydial Infection
Interventions: Drug: Azithromycin
Drug: Doxycycline

  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
Azithromycin Arm Azithromycin 1 gm oral single dose
Doxycycline Arm Doxycycline 100 mg oral twice a day for 7 days

Participant Flow:   Overall Study
    Azithromycin Arm     Doxycycline Arm  
STARTED     284     283  
COMPLETED     155 [1]   155 [1]
NOT COMPLETED     129     128  
Discharged from facility                 89                 96  
Received other antichlamydia treatment                 20                 14  
Negative for chlamydia at enrollment                 12                 9  
Various other reasons                 8                 9  
[1] Completed primary evaluation at study visit # 2 (day 28 after therapy started)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline.

Reporting Groups
  Description
Azithromycin Arm Azithromycin 1 gm oral single dose
Doxycycline Arm Doxycycline 100 mg oral twice a day for 7 days
Total Total of all reporting groups

Baseline Measures
    Azithromycin Arm     Doxycycline Arm     Total  
Number of Participants  
[units: participants]
  155     155     310  
Age  
[units: participants]
     
<=18 years     155     154     309  
Between 18 and 65 years     0     1     1  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  17.0  (0.9)     16.8  (1.1)     16.9  (1.0)  
Gender  
[units: participants]
     
Female     53     56     109  
Male     102     99     201  
Region of Enrollment  
[units: participants]
     
United States     155     155     310  



  Outcome Measures

1.  Primary:   Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized.   [ Time Frame: Study visit # 2 (Day 28 after therapy started) ]

2.  Secondary:   Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome.   [ Time Frame: Baseline and study visit #2 (Day 28 after therapy is started) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The analysis of the secondary endpoint Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome was limited by the small number of events and is not presented.


  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.


Results Point of Contact:  
Name/Title: Shelly Lensing, Statistician
Organization: University of Arkansas for Medical Sciences
phone: 501-686-8203
e-mail: sylensing@uams.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00980148     History of Changes
Other Study ID Numbers: 07-0012
Study First Received: September 17, 2009
Results First Received: March 5, 2015
Last Updated: March 5, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration