Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Aspergillosis

Treatments: Drug: voriconazole; Drug: anidulafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00531479

A8851009

Details and patient eligibility

About

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.

Enrollment: 459 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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459 participants in 2 patient groups

Voriconazole

Active Comparator group

Description:

Voriconazole monotherapy

Treatment:

Drug: voriconazole

Drug: voriconazole

Voriconazole and Anidulafungin

Experimental group

Description:

Combination therapy with voriconazole and anidulafungin

Treatment:

Drug: anidulafungin

Drug: voriconazole

Drug: voriconazole