NCT04194086

Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.

Detailed description

Posaconazole as a new triazole antifungal agent with broad spectrum coverage, was recommended for prophylaxis of invasive fungal disease in adults. Some studies have demonstrated the relationship between posaconazole plasma concentration and efficacy and few data have been published in children with leukemia.The purpose of this study is to describe the off-label use of posaconazole oral suspensions in children;to figure out the relationship between concentration and clinical outcomes/ adverse events;to identify factors that influence plasma concentration.

Conditions

• Leukemia, Acute

Interventions

Type	Name	Description
DRUG	posaconazole oral suspensions	posaconazole oral suspensions（5mg/kg/d,tid) will be administered specially febrile neutropenia patients four times a day and blood samples will be taken any hours after the first dose at least Day 7.

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-07-01
• Completion: 2021-07-30
• First posted: 2019-12-11
• Last updated: 2021-08-03

Locations

1 site across 1 country: China