Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections

NCT ID: NCT00860587

Last Updated: 2009-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Complicated Intra-Abdominal Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Division of Infectious Diseases, University Hospital, SE-581 85 Linköping

Principal Investigators

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Håkan SI Hanberger, Professor

Role: PRINCIPAL_INVESTIGATOR

Division of Infectious Diseases, University Hospital, Linköping

Other Identifiers

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Bakki

Identifier Type: -

Identifier Source: org_study_id

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