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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346735
First Posted: May 3, 2011
Last Update Posted: September 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Ramesh Venkataraman, Indian Society of Critical Care Medicine
  Purpose

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 Intervention
Nosocomial Infections Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)

Further study details as provided by Dr. Ramesh Venkataraman, Indian Society of Critical Care Medicine:

Enrollment: 381
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICU infections
Infections acquired during the ICU stay
Other: No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult ICU patients
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346735


Locations
India
Indian Society of Critical Care Medicine
Mumbai, India
Sponsors and Collaborators
Indian Society of Critical Care Medicine
  More Information

Responsible Party: Dr. Ramesh Venkataraman, Dr, Indian Society of Critical Care Medicine
ClinicalTrials.gov Identifier: NCT01346735     History of Changes
Other Study ID Numbers: ISCCM1
First Submitted: May 2, 2011
First Posted: May 3, 2011
Last Update Posted: September 1, 2016
Last Verified: August 2016

Keywords provided by Dr. Ramesh Venkataraman, 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:
Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes