CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Posaconazole IV +2 moredrug
Likely dose
Posaconazole IV 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04218851
NCT04218851Phase 2Completed

A Phase 2, Open-Label, Non-Comparative Clinical Trial to Study the Safety and Efficacy of Posaconazole (POS, MK-5592) in Pediatric Participants Aged 2 to Less Than 18 Years With Invasive Aspergillosis

Merck Sharp & Dohme LLC·interventional·Posted Jan 6, 2020·Updated Jan 14, 2025

In Brief

A Phase 2 clinical trial evaluating Posaconazole IV, Posaconazole PFS, and 1 other intervention for Invasive Aspergillosis. Completed, enrolled 31 participants across 29 sites in 10 countries.

Detailed Summary

This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS) intravenous (IV) and oral formulations in pediatric participants 2 to \<18 years of age with invasive aspergillosis (IA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Greece, Hungary, Israel, Italy, Mexico, Peru, Russia, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 6, 2020
Enrollment StartJul 2, 2020
Primary CompletionDec 18, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.5 years ago

Interventions

Posaconazole IVdrug

Posaconazole (POS) 6 mg/kg body weight by IV infusion

Posaconazole PFSdrug

Dosing based on weight-band taken orally

Posaconazole tabletdrug

POS tablet 300 mg taken orally