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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00728624
First received: August 4, 2008
Last updated: August 26, 2010
Last verified: August 2010
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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
| 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) |
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
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 Genetic Predisposition to Disease Disease Attributes Pathologic Processes |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013