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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00728624
First received: August 4, 2008
Last updated: August 26, 2010
Last verified: August 2010
  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
Infection
Phase 0

Study Type: Observational
Study Design: Time Perspective: 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

Resource links provided by NLM:


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 ]

Enrollment: 2039
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

n/a n/a

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 082
Pfizer Investigational Site
Bangalore, Karnataka, India, 560034
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 076
Pfizer Investigational Site
Manipal, Karnataka, India, 576 104
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 016
Pfizer Investigational Site
Chandigarh, Punjab, India, 160 012
Pfizer Investigational Site
Porur, Chennai, Tamil Nadu, India
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 098
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 029
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 027
Pfizer Investigational Site
Chennai, India, 600 006
Pfizer Investigational Site
New Delhi, India, 110 029
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00728624     History of Changes
Other Study ID Numbers: A1891005
Study First Received: August 4, 2008
Last Updated: August 26, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Pfizer:
Antibiotic susceptibility; beta lactamase; ESBLs

Additional relevant MeSH terms:
Disease Susceptibility
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014