Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infection
Intervention: Extended-Spectrum-Lactamases (ESBLs) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager, Principal Investigator, Affiliation: For China medinfo@wyeth.com
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.
Clinical Details
Official title: Association of Antibiotic Utilization Measures and Control of Extended-spectrum-lactamases (ESBLs)
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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 outcome: Infection rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: June 2004
Last updated: April 13, 2011
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