- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00607659
Immunopathogenesis of Chlamydia
April 12, 2016 updated by: Arkansas Children's Hospital Research Institute
Immunopathogenesis of Chlamydia Trachomatis Infection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 21 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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 .
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No intervention, only observational
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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
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No intervention, only observational
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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enrollment,3,6,12,24,36 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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enrollment,3,6,12,24,36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Amy M Scurlock, M.D., Arkansas Children's Hospital Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1128/IAI.69.3.1832-1840.2001.
- 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.
- 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.
- 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.
- 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. doi: 10.1053/j.spid.2005.06.004.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
January 1, 2016
Study Completion (ACTUAL)
January 1, 2016
Study Registration Dates
First Submitted
January 8, 2008
First Submitted That Met QC Criteria
January 23, 2008
First Posted (ESTIMATE)
February 6, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
April 14, 2016
Last Update Submitted That Met QC Criteria
April 12, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #99416
- Chaos # 1634-2
- NIH 5 R01 AI051417-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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