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

March 7, 2017 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

n/a n/a

Study Type

Observational

Enrollment (Actual)

2039

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chennai, India, 600 006
        • Pfizer Investigational Site
      • New Delhi, India, 110 029
        • Pfizer Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 082
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 076
        • Pfizer Investigational Site
      • Bangalore, Karnataka, India, 560034
        • Pfizer Investigational Site
      • Manipal, Karnataka, India, 576 104
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 016
        • Pfizer Investigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160 012
        • Pfizer Investigational Site
    • Tamil Nadu
      • Porur, Chennai, Tamil Nadu, India
        • Pfizer Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700 029
        • Pfizer Investigational Site
      • Kolkata, West Bengal, India, 700 027
        • Pfizer Investigational Site
      • Kolkata, West Bengal, India, 700 098
        • Pfizer Investigational Site

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Isolates from hospitalised patients

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of antimicrobial susceptibility using disc-diffusion method
Time Frame: duration of trial
duration of trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients
Time Frame: duration of trial
duration of trial

Collaborators and Investigators

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

Sponsor

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

November 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1891005

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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