Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

Pfizer

Status and phase: Withdrawn; Phase 3

Conditions: Invasive Pulmonary Aspergillosis; Neuroaspergillosis; Aspergillosis

Treatments: Drug: Voriconazole; Drug: Anidulafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01188759

A1501095

Details and patient eligibility

About

This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of proven, probable, or possible invasive aspergillosis.
• Hematologic malignancy or allogeneic hematopoetic stem cell transplant.

Exclusion criteria

• Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
• Chronic invasive aspergillosis.
• Receipt of antifungal treatment for more than 96 hours.
• Severe liver dysfunction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Voriconazole and Anidulafungin Combination

Experimental group

Description:

Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy.

Treatment:

Drug: Voriconazole

Drug: Voriconazole

Drug: Anidulafungin

Voriconazole Monotherapy

Active Comparator group

Description:

Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.

Treatment:

Drug: Voriconazole

Drug: Voriconazole