Immunopathogenesis of Chlamydia

CHLAMYDIA INFECTIONS Clinical Trial

Official title:

Immunopathogenesis of Chlamydia Trachomatis Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607659
• Other study ID #: IRB #99416
• Secondary ID: Chaos # 1634-2NI
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: April 12, 2016
• Start date: January 2008
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• CHLAMYDIA INFECTIONS
• Infection

Intervention

Other:
• No intervention, only observational
No intervention, only observational

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

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

External Links

•   Arkansas Children's Hospital Main Page