A Laboratory-based Surveillance Study of Candida Bloodstream Infections (0991-093)
This study has been completed.
Sponsor:
Merck
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01174147
First received: July 30, 2010
Last updated: December 28, 2012
Last verified: December 2012
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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:
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 |
| 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 June 18, 2013