NCT00728624

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,039

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Shorter than P25 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

August 4, 2008

Last Update Submit

March 7, 2017

Conditions

Keywords

Antibiotic susceptibility; beta lactamase; ESBLs

Outcome Measures

Primary Outcomes (1)

  • Comparison of antimicrobial susceptibility using disc-diffusion method

    duration of trial

Secondary Outcomes (1)

  • Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients

    duration of trial

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Isolates from hospitalised patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500 082, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 076, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560034, India

Location

Pfizer Investigational Site

Manipal, Karnataka, 576 104, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 016, India

Location

Pfizer Investigational Site

Chandigarh, Punjab, 160 012, India

Location

Pfizer Investigational Site

Porur, Chennai, Tamil Nadu, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 700 027, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 700 029, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 700 098, India

Location

Pfizer Investigational Site

Chennai, 600 006, India

Location

Pfizer Investigational Site

New Delhi, 110 029, India

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 6, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations