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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01077336
Other study ID # G098881
Secondary ID
Status Completed
Phase N/A
First received February 25, 2010
Last updated July 15, 2014
Start date January 2010
Est. completion date January 2011

Study information

Verified date July 2014
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 450
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Houston Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Assess empiric choice of antifungal therapy in hospitalized patients with candidemia. Assessments made for 30-days after postivie blood culture No
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