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Completed

NCT Number: NCT00607659

Immunopathogenesis of Chlamydia

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention, only observational

Other

No intervention, only observational

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

    Time frame: 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

    Time frame: enrollment,3,6,12,24,36 months

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Immunopathogenesis of Chlamydia Trachomatis Infection

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2008
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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