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
  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 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Kevin W. Garey, Professor and Chair, University of Houston
ClinicalTrials.gov Identifier: NCT01077336     History of Changes
Other Study ID Numbers: G098881
Study First Received: February 25, 2010
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Houston:
susceptibility testing

Additional relevant MeSH terms:
Disease Susceptibility
Candidemia
Disease Attributes
Pathologic Processes
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on July 20, 2014