A Laboratory-based Surveillance Study of Candida Bloodstream Infections (MK-0991-093)
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|ClinicalTrials.gov Identifier: NCT01174147|
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : October 13, 2016
Merck Sharp & Dohme Corp.
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||436 participants|
|Official Title:||Brazilian Network of Candidemia: a Laboratory-based Surveillance Study on Candida Bloodstream Infections in 10 Medical Centers|
|Study Start Date :||April 2010|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
Hospital Candida Cases
People who developed a positive blood culture for Candida while hospitalized
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.
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