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

NCT04665037 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-18

No results posted yet for this study

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).

Conditions

  • Invasive Fungal Infection

Interventions

DRUG

Posaconazole IV 6 mg/kg

POS 6 mg/kg body weight by IV infusion

DRUG

Posaconazole PFS 6 mg/kg

POS nominal 6 mg/kg body weight based on weight bands taken orally

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Day
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2026-12-16
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Greece
  • Israel
  • Mexico
  • Peru
  • Poland
  • Russia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665037 on ClinicalTrials.gov