drugset / Trial / NCT01782131
A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069)
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2013-09-25
- Primary completion
- 2019-07-10
- Completion
- 2019-09-10
Outcome
Met primary endpoint
registry NUMBER Posaconazole: 15.3 Percentage of Participants NUMBER Voriconazole: 20.6 Percentage of Participants NCT01782131 ↗
registry analysis (non-inferiority test); Posaconazole vs Voriconazole; p <.0001; Estimated Difference in Percent -5.3 (95% CI -11.6 to 1.0); Miettinen and Nurminen NCT01782131 ↗
Publications
- Results Maertens JA, Rahav G, Lee DG, Haider S, Ramirez-Sanchez IC, Klimko N, Ponce-de-Leon A, Han S, Wrishko R, Winchell GA, Grandhi A, Waskin H; study investigators. Pharmacokinetic and Exposure Response Analysis of the Double-Blind Randomized Study of Posaconazole and Voriconazole for Treatment of Invasive Aspergillosis. Clin Drug Investig. 2023 Sep;43(9):681-690. doi: 10.1007/s40261-023-01282-7. Epub 2023 Sep 7.
- Maertens JA, Rahav G, Lee DG, Ponce-de-Leon A, Ramirez Sanchez IC, Klimko N, Sonet A, Haider S, Diego Velez J, Raad I, Koh LP, Karthaus M, Zhou J, Ben-Ami R, Motyl MR, Han S, Grandhi A, Waskin H; study investigators. Posaconazole versus voriconazole for primary treatment of invasive aspergillosis: a phase 3, randomised, controlled, non-inferiority trial. Lancet. 2021 Feb 6;397(10273):499-509. doi: 10.1016/S0140-6736(21)00219-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 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 | Unknown | 300 mg | Intravenous |
| Comparator | 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 | Unknown | 4 mg/kg | Intravenous |
| Comparator | 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 | Unknown | 200 mg | Intravenous |