Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants (VOSIFI)

This study has been completed.

Sponsor:

Collaborator:

European Group for Blood and Marrow Transplantation

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00143312

First received: August 31, 2005

Last updated: September 23, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

September 23, 2009

Start Date ^ICMJE

February 2005

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy of Voriconazole as secondary prophylaxis on rate of occurrence of proven and probable invasive fungal infection up to 12 months FU

Change History

Complete list of historical versions of study NCT00143312 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit [ Time Frame: 150 days ] [ Designated as safety issue: No ]
Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Survival Without Proven or Probable Invasive Fungal Infection (IFI) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy at 6 months FU Efficacy until EOP visit Evaluate time to/of IFI Evaluate proportion of patients experiencing proven/probable recurrent/new IFI's Survival free at 6 and 12 months Safety and tolerability

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants

Official Title ^ICMJE

Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).

Brief Summary

To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Prophylaxis Of Invasive Fungal Infections

Intervention ^ICMJE

Drug: voriconazole

Voriconazole is given to patients at least 48 hours after chemotherapy

Study Arm (s)

Experimental: 1

Intervention: Drug: voriconazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease

Exclusion Criteria:

Pregnant or lactating women
Severe disease other tham the underlying condition
Active, symptomatic uncontrolled Invasive Fungal Infection
Any evidence of active fungal disease as defined by MSG-EORTC criteria
Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
Other medical conditions, including HIV positive serology that would interfere with the evaluation of therapeutic response or safety of study drug

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, France, Germany, Portugal, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00143312

Other Study ID Numbers ^ICMJE

A1501038

Has Data Monitoring Committee

Yes

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

European Group for Blood and Marrow Transplantation

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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