Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (Bakki)

Risk Factors for Colonization and Infection With Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (IAI). An Open Observational Study

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with evidence of severe intra-abdominal infections.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Håkan SI Hanberger, Professor, Division of Infectious Diseases, University Hospital, Linköping

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (ANTICIPATED): October 1, 2009
• Study Completion (ANTICIPATED): October 1, 2009

Study Registration Dates

• First Submitted: March 11, 2009
• First Submitted That Met QC Criteria: March 11, 2009
• First Posted (ESTIMATE): March 12, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 12, 2009
• Last Update Submitted That Met QC Criteria: March 11, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Antibiotic resistance; Antibiotic treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Intraabdominal Infections
• Other Study ID Numbers: Bakki