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

NCT00728624

Last updated date
Study Location
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 082, India
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title Assessing Prevalence Of Beta Lactamase Production From Clinical Isolates Of Hospitalized Patients And Comparison Of Antibiotic Susceptibility Patterns
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
Brief 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
Detailed Description n/a n/a
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Isolates from hospitalised patients
Condition Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 18, 2010)
2039
Original Estimated Enrollment
 (submitted: August 5, 2008)
2000
Actual Study Completion Date September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00728624
Other Study ID Numbers A1891005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017