Immunopathogenesis of Chlamydia

Study Overview
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Brief Summary
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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
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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

Official Title
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Immunopathogenesis of Chlamydia Trachomatis Infection

Conditions
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CHLAMYDIA INFECTIONS

Intervention / Treatment
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* Other: No intervention, only observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chlamydia Positive<br>Adolescent females, 11-21 years old, evaluated for pelvic examinations or STI screening will be asked to participate in this study. Participants are being asked to give us permission to collect:additional cervical or vaginal swabs, rectal swabs, blood draws where three tablespoons of blood, a urine pregnancy test, and a comprehensive health history. You may be asked to provide a urine specimen at the initial visit instead of having a cervical swab. The study team will obtain a cervical swab when you come back for your follow-up appointments. If your culture is positive for Chlamydia, you will be asked attend 3 additional follow-up appointments after 3 months, 6 months, 1 year, 2 years, and 3 years . | Other: No intervention, only observational<br>* No intervention, only observational<br>|
| Control/Chlamydia Negative<br>Some participants with negative cultures will be included in this study as a control group. The same specimens, exams and blood draws will apply for those subjects with visits at 3 months, 6 months, 1 year, 2 years, and 3 years | Other: No intervention, only observational<br>* No intervention, only observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | enrollment,3,6,12,24,36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlamydia, Chlamydia trachomatis, Adolescent Health, Female Health, Sexually Transmitted Infections, Infertility, Pelvic Inflammatory Disease