Study Evaluation Tazocin Intervention - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00488189

Purpose

This is an antibiotic intervention study to determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K.

pneumoniae colonization and infection.

Condition	Intervention	Phase
Bacterial Infections	Drug: Tazocin (pipercillin/tazobactam)	Phase IV

MedlinePlus related topics: Antibiotics Bacterial Infections Pneumonia

Drug Information available for: Piperacillin sodium Piperacillin Tazobactam Zosyn

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Efficacy Study, Health Services Research, Non-Randomized, Open Label, Single Group Assignment, Uncontrolled
Official Title:	Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) Producing Bacteria

Further study details as provided by Wyeth:

Primary Outcome Measures:

1. The acquisition rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The infection rate due to ESBL producing E. coli or K. pnumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	May 2007
Estimated Study Completion Date:	January 2008
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention baseline, collecting rectal swab samples
2: Active Comparator use pipercill/tazobact to replace 3rd generation cephalosporin and collect rectal swab	Drug: Tazocin (pipercillin/tazobactam) over 50% third generation cephalosporin should be replaced by Pip/Taz

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients admitted or transferred to ICU/Pulmonary units
Patients of either sex, 18 years of age or older

Exclusion Criteria:

Patients who stay in units less than 48 hours will not be enrolled.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488189

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

China
	Recruiting
Beijing, China, 100037

Sponsors and Collaborators

Wyeth

Investigators

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

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0910X-102370
Study First Received:	June 18, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00488189 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Cephalosporins
Anti-Bacterial Agents
Cefixime

Tazobactam
Piperacillin
Piperacillin-tazobactam combination product

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses

Piperacillin
Piperacillin-tazobactam combination product
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 16, 2009