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COMPLETED
NCT00980148
PHASE3

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

Chlamydia is a common infection among youth and can be given from one person to another during sex. Many people who have chlamydia have no signs of infection at all, but can pass the infection to anyone they have sex with. If not treated, chlamydia can lead to serious health problems. This study will look at how well medicines given for chlamydia infection work. The study requires 306 evaluable subjects, chlamydia-positive, males and non-pregnant females, ages 12-21, living in long-term, gender-segregated youth correctional facilities. Participants will be assigned to receive either doxycycline (2 times per day, by mouth, for 7 days) or azithromycin (1 single dose by mouth). Study procedures will include collection of at least 3 urine samples to test for chlamydia. Study visits will occur during initial enrollment in the study, day 28 after starting treatment, and day 67. Participants will be involved in study related procedures for up to 67 days.

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

Key Details

Gender

All

Age Range

12 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

567

Start Date

2009-12-02

Completion Date

2014-05-27

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DRUG

Azithromycin

FDA approved, a 1 gm single dose, two 500 mg tablets.

DRUG

Doxycycline

FDA approved, a 100 mg capsule twice a day for 7 days.

Locations (2)

University of Alabama Hospital - Infectious Diseases

Birmingham, Alabama, United States

Los Angeles County Department of Public Health - Sexually Transmitted Disease Program

Los Angeles, California, United States