Study Evaluating the Etiology of Intra-Abdominal Infections

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00244088
First received: October 21, 2005
Last updated: August 31, 2009
Last verified: August 2009
  Purpose

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.


Condition
Intra-abdominal Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of the Etiology of Intra-Abdominal Infections

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Biospecimen Retention:   Samples Without DNA

Intra-abdominal fluid


Estimated Enrollment: 340
Study Start Date: April 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Surgery units

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:

-

  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: NCT00244088

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00244088     History of Changes
Other Study ID Numbers: 101316
Study First Received: October 21, 2005
Last Updated: August 31, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Abdominal infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Intraabdominal Infections

ClinicalTrials.gov processed this record on October 01, 2014