Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
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|ClinicalTrials.gov Identifier: NCT00980148|
Recruitment Status : Completed
First Posted : September 18, 2009
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chlamydial Infection||Drug: Azithromycin Drug: Doxycycline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||567 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial Evaluating Treatment Failure Following Recommended Therapy (Azithromycin Versus Doxycycline) for Genital Chlamydial Infection in Males and Females in Youth Correctional Facilities|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Doxycycline 100 mg oral twice a day (BID) for 7 days; 153 subjects
FDA approved, a 100 mg capsule twice a day for 7 days.
Experimental: Arm 1
Azithromycin 1 gm oral single dose; 153 subjects
FDA approved, a 1 gm single dose, two 500 mg tablets.
- 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) ]The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).
- Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome. [ Time Frame: Baseline and study visit #2 (Day 28 after therapy is started) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980148
|United States, Alabama|
|University of Alabama Hospital - Infectious Diseases|
|Birmingham, Alabama, United States, 35249-0001|
|United States, California|
|Los Angeles County Department of Public Health - Sexually Transmitted Disease Program|
|Los Angeles, California, United States, 90007-2608|