Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants (VOSIFI)
This study has been completed.
Sponsor:
Pfizer
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
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Purpose
To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants
| Condition | Intervention | Phase |
|---|---|---|
|
Prophylaxis Of Invasive Fungal Infections |
Drug: voriconazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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). |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 45 |
| Study Start Date: | February 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: voriconazole
Voriconazole is given to patients at least 48 hours after chemotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143312
Locations
| Belgium | |
| Pfizer Investigational Site | |
| Leuven, Belgium, 3000 | |
| France | |
| Pfizer Investigational Site | |
| Marseille, Cedex 09, France, 13273 | |
| Pfizer Investigational Site | |
| Creteil, France, 94010 | |
| Pfizer Investigational Site | |
| Nantes, France, 44035 cedex | |
| Pfizer Investigational Site | |
| Pessac, France, 33600 | |
| Pfizer Investigational Site | |
| Strasbourg, France, 67098 | |
| Germany | |
| Pfizer Investigational Site | |
| Koeln, Germany, 50937 | |
| Pfizer Investigational Site | |
| Mainz, Germany, 55101 | |
| Pfizer Investigational Site | |
| Wuerzburg, Germany, 97070 | |
| Portugal | |
| Pfizer Investigational Site | |
| Lisboa, Portugal, 1099-023 | |
| Spain | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08025 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28006 | |
| Sweden | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 141 86 | |
| Switzerland | |
| Pfizer Investigational Site | |
| CH-4031 Basel, Switzerland | |
| United Kingdom | |
| Pfizer Investigational Site | |
| London, United Kingdom, W12 0NN | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M20 4BX | |
Sponsors and Collaborators
Pfizer
European Group for Blood and Marrow Transplantation
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00143312 History of Changes |
| Other Study ID Numbers: | A1501038 |
| Study First Received: | August 31, 2005 |
| Results First Received: | April 2, 2009 |
| Last Updated: | September 23, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Pfizer:
|
Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole |
Additional relevant MeSH terms:
|
Mycoses Voriconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013