Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections

Complicated Intra-Abdominal Infections Clinical Trial

— Bakki  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00860587
• Other study ID #: Bakki
• Status: Active, not recruiting
• Phase: N/A
• First received: March 11, 2009
• Last updated: March 11, 2009
• Start date: February 2006
• Est. completion date: October 2009

Study information

• Verified date: March 2009
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Intra-Abdominal Infections
• Infection
• Intraabdominal Infections

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No