Immunopathogenesis of Chlamydia Trachomatis Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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 Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 11 Years to 21 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •11 to 21 years of age at the time of enrollment
- •Positive for Chlamydia infections by urine or cervical PCR
- •5th Chlamydia-negative subject who fits all other inclusion criteria
- •Negative pregnancy test
- •Written informed consent provided
- •Signed a HIPAA authorization form
- •Willingness to comply with all the requirements of the protocol
Exclusion Criteria
- •Positive pregnancy test
- •Negative for Chlamydia, unless 5th negative subject to be in the control group
- •Any condition that in the opinion of the investigator would interfere with the ability of the potential subject to complete the study or would result in significant risk to the subject
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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(enrollment,3,6,12,24,36 months)