Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract

This study has been withdrawn prior to enrollment.
(Study redesigned and re-submitted to UAMS IRB under different study title and IRB number.)
Sponsor:
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00578188
First received: December 19, 2007
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

The purpose of this study is to determine if Chlamydial infections persist in the rectum of females who have had a sexually transmitted infection of Chlamydia.


Condition
Chlamydia Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Biospecimen Retention:   Samples With DNA

Serum, whole blood, tissue


Estimated Enrollment: 300
Study Start Date: February 2006
Estimated Study Completion Date: January 2008
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
RP100-400
Subjects with Chlamydia. The control group will also be identified with these numbers.

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

11-19 year old females from the Arkansas Children's Hospital Adolescent Center

Criteria

Inclusion Criteria:

  • 11-19 years old
  • Female
  • Diagnosis of Chlamydia on enrollment visit
  • Invitation to participate control group

Exclusion Criteria:

  • Age out of range
  • Negative Chlamydia screen (unless qualifies for control group)
  • Unable to provide needed samples
  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: NCT00578188

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, MD Arkansas Children's Hospital Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: Amy Scurlock, MD, Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00578188     History of Changes
Other Study ID Numbers: IRB # 43921, ACH GL #039005
Study First Received: December 19, 2007
Last Updated: June 13, 2008
Health Authority: United States: Federal Government

Keywords provided by Arkansas Children's Hospital Research Institute:
Adolescent Health
Sexually transmitted infection
Women's Health

Additional relevant MeSH terms:
Infection
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 September 18, 2014