Clinical trial NCT00143312: Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prophylaxis Of Invasive Fungal Infections
Keywords: Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: European Society for Blood and Marrow Transplantation
First posted: 2005-09-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
timeFrame: 12 months
Secondary outcomes:
measure: Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit
timeFrame: 6 months
measure: Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit
timeFrame: 150 days
measure: Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)
timeFrame: 12 months
measure: Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)
timeFrame: 12 months
measure: Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)
timeFrame: 12 months
measure: Survival Without Proven or Probable Invasive Fungal Infection (IFI)
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
state: Cedex 09
city: Creteil
country: France
facility: Pfizer Investigational Site
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Pessac
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: CH-4031 Basel
country: Switzerland
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: