A Laboratory-based Surveillance Study of Candida Bloodstream Infections (MK-0991-093)

Candidemia Clinical Trial

Official title:

Brazilian Network of Candidemia: a Laboratory-based Surveillance Study on Candida Bloodstream Infections in 10 Medical Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174147
• Other study ID #: 0991-093
• Status: Completed
• Phase: N/A
• First received: July 30, 2010
• Last updated: October 12, 2016
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hospitalized in a participating medical center

• Developed candidemia blood stream infection (confirmed by isolation of Candida species from blood culture)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Candidemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Candidemia per 1000 hospital admissions	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])	Approximately 1 year	No
Primary	Number of participants with Candidemia per 1000 patient-Days in hospital	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]).	Approximately 1 year	No
Primary	Percentage of Specific Candida Isolates Susceptible to Amphotericin B, Fluconazole, Voriconazole, Anidulafungin, and Caspofungin	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.	Approximately 1 year	No