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Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)

NCT04218851 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-01-14

Study results available
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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).

Conditions

  • Invasive Aspergillosis

Interventions

DRUG

Posaconazole IV

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

DRUG

Posaconazole PFS

Dosing based on weight-band taken orally

DRUG

Posaconazole tablet

POS tablet 300 mg taken orally

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2023-12-18
Completion
2023-12-18
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Greece
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Peru
  • Russia
  • South Korea

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 NCT04218851 on ClinicalTrials.gov