Phase 4
Completed N=45
Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
Prophylaxis Of Invasive Fungal Infections
Source: ClinicalTrials.gov NCT00143312 ↗
Enrolled (actual)
45
Serious AEs
51.1%
Results posted
Jun 2009
Primary outcomePrimary: Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit — 3 participants
Summary
To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit |
3 | — |
| SECONDARY Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit |
3 | — |
| SECONDARY Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit |
3 | — |
| SECONDARY Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI) |
6; 22; 81 | — |
| SECONDARY Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI) |
81 | — |
| SECONDARY Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI) |
6; 22 | — |
| SECONDARY Survival Without Proven or Probable Invasive Fungal Infection (IFI) |
31; 27 | — |
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
Data sourced from ClinicalTrials.gov (NCT00143312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.