NCT01782131

A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069)

A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults and Adolescents (Phase 3; Protocol No. MK-5592-069)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 585 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of posaconazole (POS) versus voriconazole (VOR) in the treatment of adults and adolescents with invasive aspergillosis (IA). The primary hypothesis is that the all-cause mortality through Day 42 in the POS treatment group is non-inferior to that in the VOR treatment group.

Conditions

• Fungal Infections
• Invasive Pulmonary Aspergillosis

Interventions

Type	Name	Description
DRUG	Posaconazole	POS IV: Day 1: 300 mg BID Day 2-84: 300 mg QD POS oral: Day 1: 300 mg BID Day 2-84: 300 mg QD
DRUG	Voriconazole	VOR IV: Day 1: 6 mg/kg per body weight administered BID Day 2-84: 4 mg/kg per body weight administered BID VOR oral: Day 1: 300 mg BID Day 2-84: 200 mg BID
DRUG	Placebo	Matching placebo received for Posaconazole (IV and oral) or Voriconazole (oral)

Timeline

• Start date: 2013-09-25
• Primary completion: 2019-07-10
• Completion: 2019-09-10
• First posted: 2013-02-01
• Last updated: 2024-01-18
• Results posted: 2020-08-21