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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
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 Design

Study Type : Observational
Actual Enrollment : 436 participants
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
Study Start Date : April 2010
Primary Completion Date : November 2012
Study Completion Date : November 2012
Groups and Cohorts

Hospital Candida Cases
People who developed a positive blood culture for Candida while hospitalized

Outcome Measures

Primary Outcome Measures :
  1. 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])

  2. 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]).

  3. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric patients hospitalized in participating medical centers (tertiary care hospitals) in Brazil

Inclusion Criteria:

  • Hospitalized in a participating medical center
  • Developed candidemia blood stream infection (confirmed by isolation of Candida species from blood culture)
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01174147     History of Changes
Other Study ID Numbers: 0991-093
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Candidiasis, Invasive
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes