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Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077336
First Posted: March 1, 2010
Last Update Posted: July 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kevin W. Garey, University of Houston
  Purpose
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
Blood Stream Infections Candida

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility

Further study details as provided by Kevin W. Garey, University of Houston:

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

Enrollment: 450
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hospitalized patients with candidemia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
No Contacts or Locations Provided
  More Information

Responsible Party: Kevin W. Garey, Professor and Chair, University of Houston
ClinicalTrials.gov Identifier: NCT01077336     History of Changes
Other Study ID Numbers: G098881
First Submitted: February 25, 2010
First Posted: March 1, 2010
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:
Disease Susceptibility
Candidemia
Disease Attributes
Pathologic Processes
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation