Chlamydia Trachomatis Persistence in the Female Gastroint... | NCT00578188

Studies
Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract

NCT00578188

Sponsor

Arkansas Children's Hospital Research Institute

Status

Withdrawn

Last Update Posted

Apr 13, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Chlamydia Infection

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ACH GL #039005

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study redesigned and re-submitted to UAMS IRB under different study title and IRB number.

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Jan 2008Estimated

Completion Date

Jan 2008Estimated

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Dec 19, 2007

First Posted Date

Dec 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2016

Last Update Posted Date

Apr 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RP100-400		Subjects with Chlamydia. The control group will also be identified with these numbers.

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy M Scurlock, MD	Arkansas Children's Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital		Little Rock	Arkansas	72202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9072679	Background	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.
10950788	Background	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.

ID	Term
D002690	Chlamydia Infections
D012749	Sexually Transmitted Diseases

ID	Term
D002694	Chlamydiaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses