CHLAMYDIA INFECTIONS Clinical Trial
Official title:
Immunopathogenesis of Chlamydia Trachomatis Infection
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 11 Years to 21 Years |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Arkansas Children's Hospital Research Institute | National Institutes of Health (NIH) |
United States,
Centers for Disease Control and Prevention (CDC). Chlamydia trachomatis genital infections--United States, 1995. MMWR Morb Mortal Wkly Rep. 1997 Mar 7;46(9):193-8. — View Citation
Cotter TW, Ramsey KH, Miranpuri GS, Poulsen CE, Byrne GI. Dissemination of Chlamydia trachomatis chronic genital tract infection in gamma interferon gene knockout mice. Infect Immun. 1997 Jun;65(6):2145-52. — View Citation
Darville T. Chlamydia trachomatis infections in neonates and young children. Semin Pediatr Infect Dis. 2005 Oct;16(4):235-44. Review. — View Citation
Dean D, Suchland RJ, Stamm WE. Evidence for long-term cervical persistence of Chlamydia trachomatis by omp1 genotyping. J Infect Dis. 2000 Sep;182(3):909-16. Epub 2000 Aug 17. — View Citation
Igietseme JU, Portis JL, Perry LL. Inflammation and clearance of Chlamydia trachomatis in enteric and nonenteric mucosae. Infect Immun. 2001 Mar;69(3):1832-40. — View Citation
Jones RB, Rabinovitch RA, Katz BP, Batteiger BE, Quinn TS, Terho P, Lapworth MA. Chlamydia trachomatis in the pharynx and rectum of heterosexual patients at risk for genital infection. Ann Intern Med. 1985 Jun;102(6):757-62. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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