A Laboratory-based Surveillance Study of Candida Bloodstream Infections (MK-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: October 30, 2014
Last verified: October 2014
  Purpose

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
Candidemia

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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • Hospitalized in a participating medical center
  • Developed candidemia blood stream infection (confirmed by isolation of Candida species 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: October 30, 2014
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Candidemia
Candidiasis
Candidiasis, Invasive
Fungemia
Infection
Inflammation
Mycoses
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on March 31, 2015