Phase 3
Completed N=459
Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
Source: ClinicalTrials.gov NCT00531479 ↗Enrolled (actual)
459
Serious AEs
48.2%
Results posted
Apr 2012
Primary outcomePrimary: All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis — 26; 39 participants — p=0.0434
Summary
This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis |
26; 39 | 0.0434 sig |
| SECONDARY Global Response at Week 6 |
44; 61 | — |
| SECONDARY All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA) |
44; 47 | 0.2611 |
| SECONDARY All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA) |
39; 55 | 0.0383 sig |
| SECONDARY Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA |
23; 33 | 0.1029 |
| SECONDARY Time to Death: All-Cause Mortality |
30.0; 30.0 | 0.083 |
| SECONDARY Time to Death Due to Invasive Aspergillosis (IA) |
14.0; 18.5 | 0.164 |
Eligibility Criteria
Inclusion Criteria
- Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
- Diagnosis of possible, probable, or proven invasive aspergillosis.
Exclusion Criteria
- Patients with aspergilloma or chronic aspergillosis
- Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
- Anticipated survival of less than 5 days or Karnofsky score <=20
Data sourced from ClinicalTrials.gov (NCT00531479). 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.