Study of Antibiotic Utilization Measures and Control of ESBLs in China

This study is ongoing, but not recruiting participants.

First Received: June 18, 2007 Last Updated: June 19, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00488813

Purpose

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

Condition	Intervention	Phase
ICU Patient	Drug: Third generation cephalosporins	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) in MICU1 and MICU2 at Buddhist Tzu Chi General Hospital.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Cefixime

Further study details as provided by Wyeth:

Primary Outcome Measures:

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).

Estimated Enrollment:	300
Study Start Date:	July 2004
Estimated Study Completion Date:	June 2005

Detailed Description:

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.
To compare the acquisition rates of ESBL producing E. coli or K. pneumoniae at MICU1 and MICU2 after 12 months

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488813

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Taiwan, medinfo@wyeth.com

More Information

No publications provided

Study ID Numbers:	101441
Study First Received:	June 18, 2007
Last Updated:	June 19, 2007
ClinicalTrials.gov Identifier:	NCT00488813 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Wyeth:

Tzh-Chi ESBL study

Study placed in the following topic categories:

Anti-Infective Agents
Cephalosporins
Anti-Bacterial Agents
Cefixime

Additional relevant MeSH terms:

Anti-Infective Agents
Cephalosporins
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009