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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

Tracking Information
First Submitted Date February 25, 2010
First Posted Date March 1, 2010
Last Update Posted Date July 16, 2014
Study Start Date January 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 26, 2010)
Assess empiric choice of antifungal therapy in hospitalized patients with candidemia. [ Time Frame: Assessments made for 30-days after postivie blood culture ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
Official Title Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Blood Stream Infections
  • Candida
Intervention Not Provided
Study Groups/Cohorts Hospitalized patients with candidemia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 26, 2010)
450
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01077336
Other Study ID Numbers G098881
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kevin W. Garey, University of Houston
Study Sponsor University of Houston
Collaborators Merck Sharp & Dohme Corp.
Investigators Not Provided
PRS Account University of Houston
Verification Date July 2014