NCT01346735

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. 1.To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India
  2. 2.To explore the microbiology, resistance and treatment patterns of these infections

Trial Health

87
On Track

Trial Health Score

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

Enrollment
381

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

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

May 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

May 2, 2011

Last Update Submit

August 30, 2016

Conditions

Nosocomial Infections

Keywords

Ventilator associated pneumoniaCatheter related blood stream infectionCatheter associated urinary tract infectionICU-related infections (VAP, CAUTI and CRBSI)India

Study Arms (1)

ICU infections

Infections acquired during the ICU stay

Other: No intervention

Interventions

No interventionOTHER
ICU infections

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult ICU patients

You may qualify if:

  • ICU stay \>48 hours
  • One of the following infections (VAP, CAUTI or CRBSI)

You may not qualify if:

  • Index ICU stay \< 48 hours
  • Re-admissions to the ICU within the same hospitalization
  • Age \>18 years or \<70 years
  • Known HIV serology positivity
  • Burns
  • Solid organ or Bone-marrow transplant
  • No ICU-acquired infections (specifically VAP, CAUTI and CRBSI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indian Society of Critical Care Medicine

Mumbai, India

Location

MeSH Terms

Conditions

Cross InfectionPneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealthcare-Associated PneumoniaPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 3, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

September 1, 2016

Record last verified: 2016-08

Locations

IN(1)