Immunopathogenesis of Chlamydia

NCT00607659 | Completed

• 3 other identifiers: IRB #99416Chaos # 1634-2NIH 5 R01 AI051417-04
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CHLAMYDIA INFECTIONS

Keywords

Chlamydia; Chlamydia trachomatis; Adolescent Health; Female Health; Sexually Transmitted Infections; Infertility; Pelvic Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

No intervention, only observational OTHER

No intervention, only observational

Chlamydia Positive; Control/Chlamydia Negative

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Female
• to 21 years of age at the time of enrollment
• Positive for Chlamydia infections by urine or cervical PCR
• Negative pregnancy test
• Written informed consent provided
• Signed a HIPAA authorization form
• Willingness to comply with all the requirements of the protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related Publications (6)

• 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. doi: 10.1128/IAI.69.3.1832-1840.2001.

  PMID: 11179361 BACKGROUND

• 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. doi: 10.1128/iai.65.6.2145-2152.1997.

  PMID: 9169744 BACKGROUND

• 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. doi: 10.7326/0003-4819-102-6-757.

  PMID: 3888022 BACKGROUND

• 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. doi: 10.1086/315778. Epub 2000 Aug 17.

  PMID: 10950788 BACKGROUND

• 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.

  PMID: 9072679 BACKGROUND

• Darville T. Chlamydia trachomatis infections in neonates and young children. Semin Pediatr Infect Dis. 2005 Oct;16(4):235-44. doi: 10.1053/j.spid.2005.06.004.

  PMID: 16210104 BACKGROUND

Related Links

• Arkansas Children's Hospital Main Page

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Chlamydia Infections; Sexually Transmitted Diseases; Infertility; Pelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Infection; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Amy M Scurlock, M.D.

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (1)