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Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)

Sponsor
Indian Society of Critical Care Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01346735
Collaborator
(none)
381
Enrollment
1
Location
14
Duration (Months)
27.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Most literature on ICU infections and the resistant patterns comes from the western literature. This data may not truly reflect the incidence, epidemiology and resistance patterns in developing countries such as India. However, empiric antibiotic therapy is generally initiated using western guidelines. This can potentially lead to inadequate, inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian setting. Hence in this multi-center observational study, we seek to:

  1. To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India

  2. To explore the microbiology, resistance and treatment patterns of these infections

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Actual Enrollment :
381 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
ICU infections

Infections acquired during the ICU stay

Other: No intervention

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. ICU stay >48 hours

    2. One of the following infections (VAP, CAUTI or CRBSI)

    Exclusion Criteria:

    1. Index ICU stay < 48 hours

    2. Re-admissions to the ICU within the same hospitalization

    3. Age >18 years or <70 years

    4. Known HIV serology positivity

    5. Burns

    6. Solid organ or Bone-marrow transplant

    7. No ICU-acquired infections (specifically VAP, CAUTI and CRBSI)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indian Society of Critical Care Medicine Mumbai India

    Sponsors and Collaborators

    • Indian Society of Critical Care Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Ramesh Venkataraman, Dr, Indian Society of Critical Care Medicine
    ClinicalTrials.gov Identifier:
    NCT01346735
    Other Study ID Numbers:
    • ISCCM1
    First Posted:
    May 3, 2011
    Last Update Posted:
    Sep 1, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Dr. Ramesh Venkataraman, Dr, Indian Society of Critical Care Medicine
    Ventilator associated pneumonia
    Catheter related blood stream infection
    Catheter associated urinary tract infection
    ICU-related infections (VAP, CAUTI and CRBSI)
    India
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Cross Infection

    Study Results

    No Results Posted as of Sep 1, 2016