Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections

NCT00860587 | Unknown

• 1 other identifier: Bakki
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of the study were:

1. 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. 2.To study species changes in the rectal flora among patients with severe IAI before and after antibiotic treatment and surgical intervention.
3. 3.To review guidelines for antibiotic use in participating units.
4. 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. 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. 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.

Conditions

Complicated Intra-Abdominal Infections

Keywords

Antibiotic resistance; Antibiotic treatment

Outcome Measures

Primary Outcomes (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 Outcomes (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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with evidence of severe intra-abdominal infections.

You may qualify if:

• 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.

You may not qualify if:

• Age under 18 years

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Merck Sharp & Dohme LLC: collaborator

Study Officials

• Håkan SI Hanberger, Professor

  Division of Infectious Diseases, University Hospital, Linköping

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: February 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 12, 2009

Record last verified: 2009-03