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Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)

Invasive Fungal Infection Clinical Trial

Official title:
A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection

Clinical Trial Summary

This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants <2 years of age with invasive fungal infection (IFI).

Clinical Trial Description

There are 2 panels in this study. In Panel A, POS IV will be evaluated in ≥8 participants. In Panel B, both POS IV and POS PFS will be evaluated in ≥14 participants, including ≥6 who are <3 months of age and ≥5 who transition to the PFS formulation of POS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04665037
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Status Recruiting
Phase Phase 2
Start date February 22, 2022
Completion date December 31, 2025
View Details
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