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
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.

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 September 16, 2014