Immunopathogenesis of Chlamydia

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00607659
First received: January 8, 2008
Last updated: January 18, 2012
Last verified: January 2012
  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: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Immunopathogenesis of Chlamydia Trachomatis Infection

Resource links provided by NLM:


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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Amy M Scurlock, M.D. Arkansas Children's Hospital Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00607659     History of Changes
Other Study ID Numbers: IRB #99416, Chaos # 1634-2, NIH 5 R01 AI051417-04
Study First Received: January 8, 2008
Last Updated: January 18, 2012
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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 19, 2014