Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections - Full Text View

Sponsors and Collaborators:	University Hospital, Linkoeping Merck
Information provided by:	University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT00860587

Purpose

The objectives of the study were:

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.
To study species changes in the rectal flora among patients with severe IAI before and after antibiotic treatment and surgical intervention.
To review guidelines for antibiotic use in participating units.
To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for colonization and infection with antibiotic resistant bacteria among patients with severe IAI
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.
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
Complicated Intra-Abdominal Infections

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Risk Factors for Colonization and Infection With Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (IAI). An Open Observational Study

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:

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. [ Time Frame: 48 hours - 2 weeks after end of antibiotic treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with SSI other postoperative infections caused by AB-R strains, per infection type and per bacteria species. [ Time Frame: 48 hours - 2 weeks after end of antibiotic treatment ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	February 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with evidence of severe intra-abdominal infections.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860587

Sponsors and Collaborators

University Hospital, Linkoeping

Merck

Investigators

Principal Investigator:

Håkan SI Hanberger, Professor

Division of Infectious Diseases, University Hospital, Linköping

More Information

No publications provided

Responsible Party:	Division of Infectious Diseases, University Hospital, SE-581 85 Linköping ( Professor Håkan Hanberger )
Study ID Numbers:	Bakki
Study First Received:	March 11, 2009
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00860587 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:

Antibiotic resistance
Antibiotic treatment

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009