A Laboratory-based Surveillance Study of Candida Bloodstream Infections (0991-093)

This study has been completed.
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01174147
First received: July 30, 2010
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

This study will evaluate the incidence rate of Candida blood stream infection among hospitalized patients from 10 medical centers in Brazil.


Condition
Candidiasis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Brazilian Network of Candidemia: a Laboratory-based Surveillance Study on Candida Bloodstream Infections in 10 Medical Centers

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence rate of Candida blood stream infection among hospitalized patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • rate of antifungal drug resistance [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 436
Study Start Date: April 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Hospitalized patients with candidemia

Detailed Description:

Patients with candidemia will be identified through the microbiology laboratory of each participating site. All hospitalized patients with candidemia will be eligible.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult and pediatric patients hospitalized with candidemia from 10 medical centers (tertiary care hospitals) in Brazil

Criteria

Inclusion Criteria:

  • Patient is hospitalized in selected medical center
  • Patient has candidemia blood stream infection (confirmed by isolation of Candida spp. from blood culture)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01174147     History of Changes
Other Study ID Numbers: 0991-093
Study First Received: July 30, 2010
Last Updated: December 28, 2012
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Candidiasis
Mycoses

ClinicalTrials.gov processed this record on April 17, 2014