Immunopathogenesis of Chlamydia

Arkansas Children's Hospital Research Institute

Status: Completed

Conditions: CHLAMYDIA INFECTIONS

Treatments: Other: No intervention, only observational

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00607659

Chaos # 1634-2

IRB #99416

NIH 5 R01 AI051417-04

Details and patient eligibility

About

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.

Full 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

Enrollment: 29 patients

Sex: Female

Ages: 11 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

29 participants in 2 patient groups

Chlamydia Positive

Description:

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 .

Treatment:

Other: No intervention, only observational

Control/Chlamydia Negative

Description:

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

Treatment:

Other: No intervention, only observational