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NCT01788449 Clinical Trial

Study Evaluating the Association of Antibiotic Measures and Control of Bacterial Resistance

Bacterial Infections Clinical Trial

Official title:
Association of Antibiotic Measures and Control of Bacterial Resistance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01788449
Other study ID # 0910X-101852
Secondary ID
Status Completed
Phase N/A
First received August 6, 2009
Last updated February 12, 2013
Start date May 2005
Est. completion date February 2007

Study information
Verified date February 2013
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of HealthSpain: Ministry of Health and ConsumptionSpain: Spanish Agency of Medicines
Study type Observational

Clinical Trial Summary

Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of bacteria.

Description:

Primarily, this study is designed to assess the efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of extended-spectrum betalactamases (ESBLs) producing E.coli or K pneumoniae, S aureus methicillin resistant (MRSA) and Enterococcus vancomycin resistant (VRE). Secondly, this study plans to determine the acquisition rate of ESBL producing E Coli or K pneumoniae, methicillin resistant S Aureus (MRSA) and vancomycin resistant Enterococcus spp (VRE), both pre- and post-intervention.

Recruitment information / eligibility
Status Completed
Enrollment 335
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility All patients admitted in ICU will be enrolled (who qualify for treatment).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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 Endpoints will be efficacy of piperacillin/tazobactam in reducing colonization rates and infection of E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus 8 months No
Secondary Endpoints will be acquisition and infection rate of ESBL producing E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus 8 months No
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