A Laboratory-based Surveillance Study of Candida Bloodstream Infections (MK-0991-093)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: August 3, 2010
Last Update Posted: October 13, 2016
Federal University of São Paulo
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This study will evaluate the incidence rate of Candida blood stream infection (candidemia) among people hospitalized in participating medical centers in Brazil, and will assess the antifungal drug susceptibility patterns of Candida clinical isolates. No hypotheses will be tested in the study. Candida blood stream isolates collected from people hospitalized for any reason during the study period will be sent to a core mycology laboratory for antifungal drug susceptibility testing. All people who develop candidemia while hospitalized will be considered participants in the study.
|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|
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Number of participants with Candidemia per 1000 hospital admissions [ Time Frame: Approximately 1 year ]A candidemia case was defined as the first isolation of any Candida species from blood within a 30-day period during hospitalization. The incidence of candidemia was calculated as (number of participants / [number of total people hospitalized during the study period / 1000])
- Number of participants with Candidemia per 1000 patient-Days in hospital [ Time Frame: Approximately 1 year ]A candidemia case was defined as the first isolation of any Candida species from blood within a 30-day period during hospitalization. The incidence of candidemia was calculated as (number of participants / [number of total patient-days of hospitalization during the study period / 1000]).
- Percentage of Specific Candida Isolates Susceptible to Amphotericin B, Fluconazole, Voriconazole, Anidulafungin, and Caspofungin [ Time Frame: Approximately 1 year ]Candida bloodstream isolates were tested for susceptibility to antifungal drugs using the Clinical and Laboratory Standards Institute (CLSI) microbroth dilution method with final readings recorded after 24 hours. The susceptibility cutoffs for antifungal drugs except amphotericin B were from the CLSI M27-S4 Reference Supplement (December 2012). The susceptibility cutoff for amphotericin B was obtained from the published literature.
|Study Start Date:||April 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Hospital Candida Cases
People who developed a positive blood culture for Candida while hospitalized
Contacts and Locations
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