Assessing Prevalence Of Beta Lactamase Production From Clinical Isolates Of Hospitalized Patients And Comparison Of Antibiotic Susceptibility Patterns - Full Text View

Assessing Prevalence Of Beta Lactamase Production From Clinical Isolates Of Hospitalized Patients And Comparison Of Antibiotic Susceptibility Patterns (EGAST 2008)

This study is currently recruiting participants.

Verified by Pfizer, January 2009

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00728624

Purpose

EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites).

Objectives:

Comparison of antimicrobial susceptibility using disc-diffusion method
Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients

Condition	Phase
Antibiotic Resistance, Bacterial	Phase 0

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Expert Group On Antibiotic Susceptibility Testing [EGAST] 2008: A Non-Interventional, Multicenter In-Vitro Study To Evaluate The Prevalence Of Beta-Lactamase Producing Strains Among Clinical Isolates Obtained From Hospital In-Patients And Comparison Of Antimicrobial Susceptibility Using Disc-Diffusion Method

Further study details as provided by Pfizer:

Primary Outcome Measures:

Comparison of antimicrobial susceptibility using disc-diffusion method [ Time Frame: duration of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients [ Time Frame: duration of trial ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Isolates from hospitalised patients

Criteria

Inclusion Criteria:

Isolates (as specified in the observational plan) from hospitalised patients

Exclusion Criteria:

Isolates obtained from outpatients will not be included for the study. Isolates from repeat cultures performed during in-patient follow-up that were previously recruited into the study will be excluded.

Isolates identified as commensals or contaminants will be excluded

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728624

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

India, West Bengal
Pfizer Investigational Site	Recruiting
Kolkata, West Bengal, India, 700 029

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1891005
Study First Received:	August 4, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00728624
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

Antibiotic susceptibility; beta lactamase; ESBLs

Study placed in the following topic categories:

Disease Susceptibility
Genetic Predisposition to Disease

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009