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

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01174147

Collaborator

Federal University of São Paulo (Other)

436

Enrollment

Duration (Months)

Study Details

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	Intervention/Treatment	Phase
Candidemia

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 :

Apr 1, 2010

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Hospital Candida Cases People who developed a positive blood culture for Candida while hospitalized

Outcome Measures

Primary Outcome Measures

Number of participants with Candidemia per 1000 hospital admissions [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 [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 [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

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Merck Sharp & Dohme LLC
Federal University of São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merck Sharp & Dohme LLC

ClinicalTrials.gov Identifier:

NCT01174147

Other Study ID Numbers:

0991-093

First Posted:

Aug 3, 2010

Last Update Posted:

Oct 13, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Sepsis

Candidemia

Study Results

No Results Posted as of Oct 13, 2016