Bakki: Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections

• Sponsor: University Hospital, Linkoeping (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00860587
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 200
• Duration (Months): 44

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complicated Intra-Abdominal Infections

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Risk Factors for Colonization and Infection With Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (IAI). An Open Observational Study
• Study Start Date: Feb 1, 2006
• Anticipated Primary Completion Date: Oct 1, 2009
• Anticipated Study Completion Date: Oct 1, 2009

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Linkoeping
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Håkan SI Hanberger, Professor, Division of Infectious Diseases, University Hospital, Linköping

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00860587
• Other Study ID Numbers: Bakki
• First Posted: Mar 12, 2009
• Last Update Posted: Mar 12, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Antibiotic resistance; Antibiotic treatment
• Additional relevant MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections

Study Results

No Results Posted as of Mar 12, 2009