A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.

Candidiasis Clinical Trial

Official title:

A Randomized, Open Label, Comparative Multicenter Study Of Voriconazole Versus Conventional Amphotericin B Followed By Fluconazole In The Treatment Of Candidaemia In Non Neutropenic Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163111
• Other study ID #: 608
• Secondary ID: A1500608
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: April 25, 2011
• Start date: September 1998
• Est. completion date: May 2003

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with candidemia

Exclusion Criteria:

• Neutropenia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidemia
• Candidiasis

Intervention

Drug:
• VFEND® I.V., Oral

• Conventional amphotericin B

• Diflucan IV, oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained clinical response for 12 weeks from end of treatment
Secondary	Time to negative blood cultures