Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)

Bacterial Infection Clinical Trial

Official title:

Association of Antibiotic Utilization Measures and Control of Extended-spectrum-lactamases (ESBLs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254696
• Other study ID #: 0910X-101462
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2005
• Last updated: April 13, 2011
• Start date: June 2004
• Est. completion date: March 2005

Study information

• Verified date: April 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

• To determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.

• To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre and post intervention in the selected medical centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 710
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted or transferred to the ICU/pulmonary/hematology units.

• Patients of either sex, 18 years of age or older

Exclusion Criteria:

• Pregnant and nursing women. Female of childbearing potential without using any birth control methods. Female of childbearing potential using oral contraceptives during study period. (Note: penicillin and beta-lactamase inhibitors may prevent oral contraceptives from working properly, increasing the chance of pregnancy).

• Patients who have the contraindications of using Tazocin (pipercillin/tazobactam)

Other exclusions apply.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections

Intervention

Drug:
• Extended-Spectrum-Lactamases (ESBLs)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months)
Secondary	Infection rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months)