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

NCT00980148 | Completed Phase 3 Results

• 1 other identifier: 07-0012
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chlamydial Infection

Keywords

Chlamydia trachomatis, Chlamydia, Doxycycline, Azithromycin

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  Study visit # 2 (Day 28 after therapy started)

Secondary Outcomes (1)

• Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome.

  Baseline and study visit #2 (Day 28 after therapy is started)

Study Arms (2)

Arm2

EXPERIMENTAL

Doxycycline 100 mg oral twice a day (BID) for 7 days; 153 subjects

Drug: Doxycycline

Arm 1

EXPERIMENTAL

Azithromycin 1 gm oral single dose; 153 subjects

Drug: Azithromycin

Interventions

Azithromycin DRUG

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

Arm 1

Doxycycline DRUG

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

Arm2

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females between the ages of 12 and 21 years
• Residing in a long-term gender-segregated (no co-ed) youth correctional facility (YCF)
• Diagnosed with genital chlamydia as determined by a screening C. trachomatis nucleic acid amplification test (NAAT)
• Anticipated length of stay at the YCF at the time of enrollment is \> 3 weeks
• Willingness to provide written consent
• Willingness to comply with study procedures

You may not qualify if:

• Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae nucleic acid amplification test (NAAT)
• Clinical diagnosis of pelvic inflammatory disease (PID) or epididymitis based on review of medical records
• Known allergy to tetracyclines or macrolides
• Currently pregnant or breastfeeding
• History of photosensitivity related to doxycycline use
• Having received antimicrobial therapy with activity against C. trachomatis within 21 days of the positive chlamydia screening NAAT or in the interval between the positive screening NAAT and study enrollment
• Any concomitant infection, which requires antimicrobial therapy with activity against C. trachomatis
• Previously enrolled in this study
• Unable to swallow pills

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

University of Alabama Hospital - Infectious Diseases

Birmingham, Alabama, 35249-0001, United States

Location

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

Los Angeles, California, 90007-2608, United States

Location

Related Publications (1)

• Geisler WM, Uniyal A, Lee JY, Lensing SY, Johnson S, Perry RC, Kadrnka CM, Kerndt PR. Azithromycin versus Doxycycline for Urogenital Chlamydia trachomatis Infection. N Engl J Med. 2015 Dec 24;373(26):2512-21. doi: 10.1056/NEJMoa1502599.

  PMID: 26699167 DERIVED

MeSH Terms

Conditions

Chlamydia Infections

Interventions

Azithromycin; Doxycycline

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Shelly Lensing, Statistician
• Organization: University of Arkansas for Medical Sciences

sylensing@uams.edu

501-686-8203

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 18, 2015
• Results First Posted: March 18, 2015

Record last verified: 2014-06

Locations

US (2)