Phase 3 N=459 Randomized Quadruple-blind Treatment

Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Aspergillosis

Bottom Line

View on ClinicalTrials.gov: NCT00531479 ↗

Enrolled (actual)

459

Serious AEs

48.2%

Results posted

Apr 2012

Primary outcome: Primary: All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis — 26; 39 participants — p=0.0434

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: voriconazole (Drug); anidulafungin (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Apr 2011

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

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.

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

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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.