NCT00244088

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

October 21, 2005

Last Update Submit

August 31, 2009

Conditions

Intra-abdominal Infection

Keywords

Abdominal infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgery units

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Intra-abdominal fluid

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 21, 2005

First Posted

October 25, 2005

Study Start

April 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

September 1, 2009

Record last verified: 2009-08