Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections

• Conditions: Complicated Intra-Abdominal Infections

• Registration Number: NCT00860587
• Lead Sponsor: University Hospital, Linkoeping

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-02
• Status Verified: 2009-03
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Last Update Submitted: 2009-03-11
• Study First Posted: 2009-03-12
• Last Update Posted: 2009-03-12
• Primary Completion: 2009-10
• Study Completion: 2009-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	48 hours - 2 weeks after end of antibiotic treatment

Secondary Outcome Measures

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