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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Indian Society of Critical Care Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Indian Society of Critical Care Medicine
ClinicalTrials.gov Identifier:
NCT01346735
First received: May 2, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  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 Indian Society of Critical Care Medicine:

Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICU infections Other: No intervention

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346735

Contacts
Contact: Ramesh Venkataraman, MD 011-91-44-28296517 ccmramesh@gmail.com
Contact: Rajesh Chawla, MD

Locations
India
Indian Society of Critical Care Medicine Not yet recruiting
Mumbai, India
Sponsors and Collaborators
Indian Society of Critical Care Medicine
  More Information

No publications provided

Responsible Party: Dr. Ramesh Venkataraman, Indian Society of Critical Care Medicine
ClinicalTrials.gov Identifier: NCT01346735     History of Changes
Other Study ID Numbers: ISCCM1
Study First Received: May 2, 2011
Last Updated: May 2, 2011
Health Authority: India: Indian Society of Critical Care Medicine

Keywords provided by 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:
Communicable Diseases
Cross Infection
Infection

ClinicalTrials.gov processed this record on October 20, 2014