Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kevin W. Garey, University of Houston
ClinicalTrials.gov Identifier:
NCT01077336
First received: February 25, 2010
Last updated: July 15, 2014
Last verified: July 2014

February 25, 2010
July 15, 2014
January 2010
January 2011   (final data collection date for primary outcome measure)
Assess empiric choice of antifungal therapy in hospitalized patients with candidemia. [ Time Frame: Assessments made for 30-days after postivie blood culture ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01077336 on ClinicalTrials.gov Archive Site
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Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility

Susceptibility testing is commonly employed in patients with bacterial infections in order to guide rational use of antibiotics; however, the use of antifungal susceptibility testing is limited due to lack of availability, costs, and delays in receiving results. The goals of antifungal susceptibility testing should mirror those of antibacterial susceptibility testing: to predict clinical response or failure. Additionally, susceptibility reports should be used as a guide for physicians when transitioning patients from parenteral to oral antifungal agents. Currently, it is unknown whether antifungal susceptibility testing impacts treatment decisions in hospitals that routinely perform Candida susceptibility testing. The purpose of this study is to evaluate the changes in antifungal treatment based on in vitro susceptibility reports and how these decisions affect mortality, recurrence of infection, and length of hospital stay in candidemia patients.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

This will be a retrospective cohort study of 400 hospitalized patients with bloodstream infections from January 2006 to January 2009 due to Candida species

  • Blood Stream Infections
  • Candida
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Hospitalized patients with candidemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized patients with bloodstream infections due to Candida species

Exclusion Criteria:

  • Patients will be excluded from this study if their medical charts contain incomplete outcome or susceptibility data. Patients treated empirically or definitively with amphotericin-based products will also be excluded
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01077336
G098881
No
Kevin W. Garey, University of Houston
University of Houston
Merck Sharp & Dohme Corp.
Not Provided
University of Houston
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP