Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

Phase 3

Withdrawn

• Conditions: Aspergillosis; Neuroaspergillosis; Invasive Pulmonary Aspergillosis
• Interventions: Drug: Voriconazole; Drug: Anidulafungin

• Registration Number: NCT01188759
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Status Verified: 2012-05
• Study Start: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-11
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voriconazole and Anidulafungin Combination	Voriconazole	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.
Voriconazole and Anidulafungin Combination	Anidulafungin	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.
Voriconazole Monotherapy	Voriconazole	Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events	12 weeks

Secondary Outcome Measures

Name	Time	Method
Global response to therapy at 6 weeks	6 weeks
Rate of all-cause mortality at 6 weeks	6 weeks
Rate of all-cause mortality at EOT	12 weeks
Global response to therapy at EOT	12 weeks