Phase 3
Completed N=489
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Antifungal Prophylaxis of Invasive Fungal Infections
Source: ClinicalTrials.gov NCT00289991 ↗
Enrolled (actual)
489
Serious AEs
42.1%
Results posted
Mar 2010
Primary outcomePrimary: Success at Day 180: Percent of Responders (Randomization Strata) — 59.1; 44.7; 52.5; 25.9 percent of participants
Summary
Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success at Day 180: Percent of Responders (Randomization Strata) |
59.1; 44.7; 52.5; 25.9; 34.5; 28.1 | — |
| SECONDARY Success at Day 100: Percent of Responders (Randomization Strata) |
65.2; 50.6; 55.9; 27.6; 43.1; 38.6 | — |
| SECONDARY Time to Breakthrough Invasive Fungal Infection (IFI) |
119.0; 77.0 | — |
| SECONDARY Percent of Subjects With Occurrence of Breakthrough IFI |
0.9; 1.2; 1.3; 1.7 | 0.7114 |
| SECONDARY Survival: Percent of Subjects Who Died at or Before Day 180 |
15.6; 15.4 | — |
| SECONDARY Time to Discontinuation of Study Treatment |
88.7; 71.5 | 0.0026 sig |
| SECONDARY Survival: Percent of Subjects Who Died Within 1 Year |
25.9; 30.7 | 0.2487 |
| SECONDARY Duration of Treatment |
96.0; 68.0 | — |
| SECONDARY Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment |
40.6; 49.4 | 0.0570 |
Eligibility Criteria
Inclusion Criteria
- Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML
- Male and Female over 12 years or greater
Exclusion Criteria
- Possible, probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)
- Previous history of zygomycosis
- Anticipated survival less than one month
Data sourced from ClinicalTrials.gov (NCT00289991). 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.