Overview

This trial is active, not recruiting.

Condition complicated intra-abdominal infections
Sponsor University Hospital, Linkoeping
Collaborator Merck Sharp & Dohme Corp.
Start date February 2006
End date October 2009
Trial size 200 participants
Trial identifier NCT00860587, Bakki

Summary

The objectives of the study were:

1. To study risk factors for colonization and infection with antibiotic resistant bacteria among patients with severe IAI before and after antibiotic treatment and surgical intervention.

2. To study species changes in the rectal flora among patients with severe IAI before and after antibiotic treatment and surgical intervention.

3. To review guidelines for antibiotic use in participating units.

4. To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for colonization and infection with antibiotic resistant bacteria among patients with severe IAI

5. To use the results from the study in the process of a more appropriate use of antibiotics in participating units and care of patients with severe IAI.

6. To study the dynamics of extended-spectrum beta-lactamase producing and wild-type Enterobacteriaceae in patients with suspected severe intra abdominal infections before, during and after antibiotic treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Primary End points for detection of AB-R Colonising index: (a) Proportion of patients colonised with AB-R strains per bacteria species.(b)Proportion of colonising cultures containing AB-R strains per bacteria species.
time frame: 48 hours - 2 weeks after end of antibiotic treatment

Secondary Outcomes

Measure
Proportion of patients with SSI other postoperative infections caused by AB-R strains, per infection type and per bacteria species.
time frame: 48 hours - 2 weeks after end of antibiotic treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with evidence of intra-abdominal infections that require surgical intervention will be eligible. - In addition will patients with intra-abdominal abscess confirmed with CT/ultrasound be eligible, but not treated with surgical intervention if estimated to require at least 5 days antibiotic treatment, with a severity needing initial intravenous administration of antibiotics. Exclusion Criteria: - Age under 18 years

Additional Information

Official title Risk Factors for Colonization and Infection With Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (IAI). An Open Observational Study
Principal investigator Håkan SI Hanberger, Professor
Description In order to evaluate if standard empirical treatment was adequate in relation to resistance pattern among most prevalent species at admission we need another 70 patients to be included with at least data and cultures from admission.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by University Hospital, Linkoeping.