Trial record 1 of 1 for: NCT00244088

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Study Evaluating the Etiology of Intra-Abdominal Infections

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ClinicalTrials.gov Identifier: NCT00244088

Recruitment Status : Completed

First Posted : October 25, 2005

Last Update Posted : September 1, 2009

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

First Submitted Date

October 21, 2005

First Posted Date

October 25, 2005

Last Update Posted Date

September 1, 2009

Study Start Date

April 2004

Actual Primary Completion Date

December 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Not Provided

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Study Evaluating the Etiology of Intra-Abdominal Infections

Official Title

Study of the Etiology of Intra-Abdominal Infections

Brief Summary

The aim of this study is to define the etiology of intra-abdominal infections, to study the role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the need for specific enterococcal antimicrobial coverage.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: Case-Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Intra-abdominal fluid

Sampling Method

Non-Probability Sample

Study Population

Surgery units

Condition

Intra-abdominal Infection

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* 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

Enrollment

340

Original Enrollment

Same as current

Actual Study Completion Date

December 2004

Actual Primary Completion Date

December 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

A case will be defined as an intra-abdominal abscess or peritoneal fluid culture that will be positive for enterococcus or an enterococcal bacteriemia in association with an intra-abdominal source of infection.
A control will be defined as a culture-positive intra-abdominal infection or bacteriemia due to an intraabdominal focus where enterococci have not been isolated.

Exclusion Criteria:

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Not Provided

Removed Location Countries

Administrative Information

NCT Number

NCT00244088

Other Study ID Numbers

101316

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Not Provided

Investigators

Principal Investigator:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

PRS Account

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

August 2009

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