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NCT00728624 Clinical Trial

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

Infection Clinical Trial

— EGAST 2008  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00728624
Other study ID # A1891005
Secondary ID
Status Completed
Phase N/A
First received August 4, 2008
Last updated March 7, 2017
Start date November 2008
Est. completion date September 2009

Study information
Verified date March 2017
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

n/a n/a

Recruitment information / eligibility
Status Completed
Enrollment 2039
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Chandigarh Punjab
India Pfizer Investigational Site Chennai
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Kolkata West Bengal
India Pfizer Investigational Site Kolkata West Bengal
India Pfizer Investigational Site Kolkata West Bengal
India Pfizer Investigational Site Manipal Karnataka
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site New Delhi
India Pfizer Investigational Site Porur, Chennai Tamil Nadu

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of antimicrobial susceptibility using disc-diffusion method duration of trial
Secondary Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients duration of trial
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