Immunopathogenesis of Chlamydia - Full Text View

Sponsors and Collaborators:	Arkansas Children's Hospital Research Institute National Institutes of Health (NIH)
Information provided by:	Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00607659

Purpose

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.

Condition	Intervention
Chlamydia Infections	Other: No intervention, only observational

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Immunopathogenesis of Chlamydia Trachomatis Infection

Resource links provided by NLM:

MedlinePlus related topics: Chlamydia Infections Infertility Pelvic Inflammatory Disease

U.S. FDA Resources

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: enrollment,3,6,12,24,36 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Endocervical or vaginal swabs, rectal swabs, blood (whole and serum),urine

Estimated Enrollment:	300
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Chlamydia Positive 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 No intervention, only observational
Control/Chlamydia Negative 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 No intervention, only observational

Groups/Cohorts

Assigned Interventions

Chlamydia Positive

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

No intervention, only observational

Control/Chlamydia Negative

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

No intervention, only observational

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

Eligibility

Ages Eligible for Study:	11 Years to 21 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Adolescent females between 11 and 21 years of age undergoing pelvic examinations or screening for STIs at the Arkansas Children's Hospital Adolescent Center will be eligible for recruitment

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607659

Locations

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202

Sponsors and Collaborators

Arkansas Children's Hospital Research Institute

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Amy M Scurlock, M.D.

Arkansas Children's Hospital Research Institute

More Information

Additional Information:

Arkansas Children's Hospital Main Page This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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.

Darville T. Chlamydia trachomatis infections in neonates and young children. Semin Pediatr Infect Dis. 2005 Oct;16(4):235-44. Review.

Responsible Party:	Arkansas Children's Hospital Research Institute/University of Arkansas for Medical Sciences ( Amy Scurlock, M.D. )
Study ID Numbers:	IRB #99416, Chaos # 1634-2, NIH 5 R01 AI051417-04
Study First Received:	January 8, 2008
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00607659 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:

Chlamydia
Chlamydia trachomatis
Adolescent Health
Female Health

Sexually Transmitted Infections
Infertility
Pelvic Inflammatory Disease

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Infertility
Sexually Transmitted Diseases

Chlamydia Infections
Pelvic Inflammatory Disease
Genital Diseases, Male
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Genital Diseases, Female
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Communicable Diseases
Chlamydiaceae Infections

Sexually Transmitted Diseases
Chlamydia Infections
Genital Diseases, Male
Infection
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 03, 2009