Clinical Trial: Immunopathogenesis of Chlamydia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Immunopathogenesis of Chlamydia Trachomatis Infection

Brief Summary: Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection.

Detailed Summary: Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection. Our target population will be adolescent females age 11-21 evaluated at the ACH Adolescent Center who are undergoing pelvic examinations or urine screening for sexually transmitted infections (STIs). Laboratory specimens obtained will include cervical and rectal swabs, urine and blood specimens, as well as, chart review and comprehensive subject interviews in the initial data collection with follow-up evaluations at 3, 6, 12, 24 and 36 months for qualifying subjects
Sponsor: Arkansas Children's Hospital Research Institute

Current Primary Outcome: Evaluate the environmental and behavioral risk factors that predispose toward adverse reproductive outcomes following C. trachomatis genital tract infection in a high risk adolescent population [ Time Frame: enrollment,3,6,12,24,36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine the prevalence of rectal C. trachomatis colonization in this high risk population and its contribution to recurrent and persistent infection and adverse reproductive outcomes such as infertility and ectopic pregnancy [ Time Frame: enrollment,3,6,12,24,36 months ]

Original Secondary Outcome: Same as current

Information By: Arkansas Children's Hospital Research Institute

Dates:
Date Received: January 8, 2008
Date Started: January 2008
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016