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

Phase 4

Completed

• Conditions: Prophylaxis Of Invasive Fungal Infections
• Interventions: Drug: voriconazole

• Registration Number: NCT00143312
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-02
• Results First Submitted QC: 2009-04-02
• Results First Posted: 2009-06-01
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	voriconazole	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit	12 months	Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up

Secondary Outcome Measures

Name	Time	Method
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit	6 months	Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit	150 days	Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit
Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)	12 months	Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)	12 months	Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.
Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)	12 months	Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.
Survival Without Proven or Probable Invasive Fungal Infection (IFI)	6 months, 12 months	Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Manchester, United Kingdom