Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility

Blood Stream Infections Clinical Trial

Official title:

Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077336
• Other study ID #: G098881
• 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

Related Conditions & MeSH terms

• Blood Stream Infections
• Candida
• Candidemia
• Disease Susceptibility

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