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Immunopathogenesis of Chlamydia

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ClinicalTrials.gov Identifier: NCT00607659
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Tracking Information
First Submitted Date January 8, 2008
First Posted Date February 6, 2008
Last Update Posted Date April 14, 2016
Study Start Date January 2008
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 23, 2008)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immunopathogenesis of Chlamydia
Official Title Immunopathogenesis of Chlamydia Trachomatis Infection
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.
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
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Endocervical or vaginal swabs, rectal swabs, blood (whole and serum),urine
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
Condition CHLAMYDIA INFECTIONS
Intervention Other: No intervention, only observational
No intervention, only observational
Study Groups/Cohorts
  • 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 .
    Intervention: 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
    Intervention: Other: No intervention, only observational
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 12, 2016)
29
Original Estimated Enrollment
 (submitted: January 23, 2008)
300
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 11 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00607659
Other Study ID Numbers IRB #99416
Chaos # 1634-2
NIH 5 R01 AI051417-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Arkansas Children's Hospital Research Institute
Study Sponsor Arkansas Children's Hospital Research Institute
Collaborators National Institutes of Health (NIH)
Investigators
Principal Investigator: Amy M Scurlock, M.D. Arkansas Children's Hospital Research Institute
PRS Account Arkansas Children's Hospital Research Institute
Verification Date April 2016