Clinical trial NCT00860587: Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections
Official title: Risk Factors for Colonization and Infection With Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (IAI). An Open Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complicated Intra-Abdominal Infections
Keywords: Antibiotic resistance
Antibiotic treatment
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with evidence of severe intra-abdominal infections.

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.

Eligibility criteria: 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

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.
timeFrame: 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.
timeFrame: 48 hours - 2 weeks after end of antibiotic treatment
Other outcomes:
Locations:
Study officials:
affiliation: Division of Infectious Diseases, University Hospital, Linköping
name: Håkan SI Hanberger, Professor
role: PRINCIPAL_INVESTIGATOR
References: