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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Bacterial Infection

Treatments: Drug: Extended-Spectrum-Lactamases (ESBLs)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254696

0910X-101462

Details and patient eligibility

About

• 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.

Enrollment: 710 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)