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OpenTrials
Completed

NCT Number: NCT00163111

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.

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

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Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with candidemia

Exclusion criteria

  • Neutropenia

Treatment and study plan

VFEND® I.V., Oral

Drug

Conventional amphotericin B

Drug

Diflucan IV, oral

Drug

Primary outcomes

  1. Sustained clinical response for 12 weeks from end of treatment

Secondary outcomes

  1. Time to negative blood cultures

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
1998
Study completion
2003
First posted
Sep 13, 2005
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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