Study of Antibiotic Utilization Measures and Control of ESBLs in China

September 4, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Association of Antibiotic Utilization Measures and Control of Extended-spectrum β-lactamases (ESBLs) in MICU1 and MICU2 at Buddhist Tzu Chi General Hospital.

A single-center, prospective, comparative, antibiotic intervention study for patients admitted to MICU1 and MICU2

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. To determine the value of using β-lactamases inhibitors in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection after 12 months.
  2. To compare the acquisition rates of ESBL producing E. coli or K. pneumoniae at MICU1 and MICU2 after 12 months

Study Type

Interventional

Enrollment

300

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients admitted or transferred to the ICU/burn units.
  • Patients of either sex, 18 years of age or older.

Exclusion Criteria:

  • Patient with hypersensitivity to penicillins, cephalosporins, and beta-lactamase inhibitors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
For both MICU1 and MICU2 (acquisition), all culture results will be collected and recorded, then analyzed to determine the ESBL acquisition rate and bacterial isolates (E. coli or K. pneumoniae).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

June 1, 2005

Study Completion (ACTUAL)

June 1, 2005

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (ESTIMATE)

June 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2009

Last Update Submitted That Met QC Criteria

September 4, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101441

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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