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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01174147

Enrollment

436

Registered

2010-08-03

Start date

2010-04-30

Completion date

2012-11-30

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidemia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results