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

NCT01174147 | Completed

• 1 other identifier: 0991-093
• Study Type: observational
• Target: 436
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Candidemia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Hospital Candida Cases

People who developed a positive blood culture for Candida while hospitalized

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric patients hospitalized in participating medical centers (tertiary care hospitals) in Brazil

You may qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Federal University of São Paulo: collaborator

MeSH Terms

Conditions

Candidemia

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 3, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 13, 2016

Record last verified: 2016-10