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.

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

Brief Summary

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.”

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

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

Intervention(s) in this Clinical Trial

  • Drug: VFEND® I.V., Oral
  • Drug: Conventional amphotericin B
  • Drug: Diflucan IV, oral

Outcome Measures for this Clinical Trial

Primary Measures

  • Sustained clinical response for 12 weeks from end of treatment

Secondary Measures

  • Time to negative blood cultures

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patients with candidemia

Exclusion Criteria:

  • Neutropenia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00163111

Study ID Number: 608

ClinicalTrials.gov Identifier: NCT00163111

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00163111