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Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility

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ClinicalTrials.gov Identifier: NCT01077336
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : July 16, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kevin W. Garey, University of Houston

Study Description
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Brief Summary:
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.

Condition or disease
Blood Stream Infections Candida

Study Design
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Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011
Groups and Cohorts
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Group/Cohort
Hospitalized patients with candidemia


Outcome Measures
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Primary Outcome Measures :
  1. Assess empiric choice of antifungal therapy in hospitalized patients with candidemia. [ Time Frame: Assessments made for 30-days after postivie blood culture ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This will be a retrospective cohort study of 400 hospitalized patients with bloodstream infections from January 2006 to January 2009 due to Candida species
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Kevin W. Garey, Professor and Chair, University of Houston
ClinicalTrials.gov Identifier: NCT01077336    
Other Study ID Numbers: G098881
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Kevin W. Garey, University of Houston:
susceptibility testing
Additional relevant MeSH terms:
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Candidemia
Disease Susceptibility
Disease Attributes
Pathologic Processes
Fungemia
Sepsis
Infection
 Candidiasis, Invasive
Candidiasis
Mycoses
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation