Expired Study
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Little Rock, Arkansas 72202


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.


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


Study is Available At:


Original ID:

IRB # 43921


NCT ID:

NCT00578188


Secondary ID:

ACH GL #039005


Study Acronym:


Brief Title:

Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract


Official Title:

Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Female


Minimum Age:

11 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Arkansas Children's Hospital Research Institute


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

Study redesigned and re-submitted to UAMS IR


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Amy M Scurlock, MD
Principal Investigator
Arkansas Children's Hospital Research Institute

Study Dates

Start Date:February 2006
Completion Date:January 2008
Completion Type:Anticipated
Primary Completion Date:January 2008
Primary Completion Type:Anticipated
Verification Date:April 2016
Last Changed Date:April 12, 2016
First Received Date:December 19, 2007

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:RP100-400
Description:Subjects with Chlamydia. The control group will also be identified with these numbers.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Arkansas Children's Hospital Research Institute

Samples and Retentions

Sample Retention:Samples With DNA
Description: Serum, whole blood, tissue
Study Population: 11-19 year old females from the Arkansas Children's Hospital Adolescent Center
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:11179361
Reference Type:Reference
Citation: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.
PMID:9169744
Reference Type:Reference
Citation: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.
PMID:3888022
Reference Type:Reference
Citation: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. Epub 2000 Aug 17.
PMID:10950788
Reference Type:Reference
Citation: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.
PMID:9072679

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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