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: June 12, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Chlamydial Infection
Drug: Azithromycin
Drug: Doxycycline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Microbiological cure; microbiological failure; unevaluable and indeterminate outcome. [ Time Frame: Study visit # 2 (Day 28 after therapy started), study visit # 3 (Day 67 after therapy started), and any non-study visit testing. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographical characteristics and clinical parameters to predict treatment outcome. [ Time Frame: Baseline, study visit #2 (Day 28 after therapy is started) and study visit #3 (Day 67 after therapy is started). ] [ Designated as safety issue: No ]

Enrollment: 567
Study Start Date: December 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Azithromycin 1 gm oral single dose; 153 subjects
Drug: Azithromycin
FDA approved, a 1 gm single dose, two 500 mg tablets.
Experimental: Arm2
Doxycycline 100 mg oral twice a day (BID) for 7 days; 153 subjects
Drug: Doxycycline
FDA approved, a 100 mg capsule twice a day for 7 days.

Detailed Description:

Genital chlamydia is a public health concern. The World Health Organization (WHO) estimates that 90 million of all new cases of sexually transmitted diseases (STDs) per year are caused by Chlamydia (C.) trachomatis. In the United States alone, approximately 3 million new cases of chlamydia are reported yearly, and the costs associated with their management and complications exceed $2 billion. Unfortunately, at least 75 percent of females with chlamydia are asymptomatic, and unless the infection is detected through chlamydia testing (screening), their infection may be transmitted to others or lead to complications. The Centers of Disease Control and Prevention (CDC) recommends either azithromycin 1 gram (gm) by mouth (PO) once or doxycycline 100 milligrams (mg) PO twice daily (BID) for 7 days as co-equal therapies for uncomplicated chlamydia. A secondary aim will be to determine demographic predictors of chlamydia treatment failure following azithromycin or doxycycline treatment, and to explore clinical parameters, which distinguish those with persistent infection. The study design of this Phase III trial will address major limitations of prior chlamydia efficacy studies and the findings will reveal both the true efficacy of azithromycin and doxycycline in uncomplicated chlamydia in adolescents and the factors that predict treatment failure. This study is designed primarily to determine the frequency of chlamydia treatment failure following either azithromycin or doxycycline regimens and to evaluate whether the efficacy of the azithromycin regimen is inferior to the doxycycline regimen. Both drugs are Food and Drug Administration (FDA) approved for use in the U.S. The study will enroll 650 males and females age 12-21 years in good health (based on vital signs and provider's clinical evaluation documented in medical records) who are residing in long-term gender-segregated (not co-ed) youth correctional facilities (YCFs) (usual stay >3 weeks) and who are identified as chlamydia-infected would comprise the study population until 306 evaluable subjects are obtained . Only individuals who have a positive chlamydia screening test are enrolled, and those with negative screening tests are excluded. Consenting chlamydia-positive subjects at the enrollment visit (study visit 1) will be enrolled, asked to provide demographic data, to provide a first-void urine sample (not a mid-stream specimen) for repeat chlamydia testing with Gen-Probe (GP) AC2 (for verification of chlamydia), and then randomized to 1 of 2 treatment arms (190 153 subjects per arm): doxycycline 100 mg PO BID for 7 days or azithromycin 1 gm PO single dose. Both therapies are given as directly observed, and side effects are evaluated at the first follow-up visit (day 28 after study drug initiation). If a subject who's GP AC2 from the enrollment treatment visit returns negative for C. trachomatis, they will be categorized as unevaluable and will be removed from the study, then the site investigator will determine whether the subject will complete this treatment or will receive other therapy. Subjects whose GP AC2 at the enrollment treatment visit is positive for C. trachomatis will then be asked to provide a first-void urine sample for repeat chlamydia testing with GP AC2 at 28- and 67-days after study drug initiation [corresponding to the first follow-up visit (study visit 2) and second follow-up visit (study visit 3), respectively].

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Other exclusion criteria, per clinician judgment, that prohibits subject from enrolling in study
  • Of note, current use of oral contraceptive agents (OCPs) is not an exclusion criterion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980148

Locations
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
Sponsors and Collaborators
  More Information

No publications provided

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
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Chlamydia trachomatis, Chlamydia, Doxycycline, Azithromycin

Additional relevant MeSH terms:
Chlamydia Infections
Communicable Diseases
Infection
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014