Posaconazole (MK-5592) IV and oral in children (less than 2 years) with IFI
- Conditions
- Fungal infection
- Registration Number
- 2023-505613-24-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
To estimate the pharmacokinetics (PK) of posaconazole (POS) intravenous (IV) and powder for oral suspension (PFS) in participants <2 years of age (Panels A and B).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 13
Panel A: Is undergoing treatment for possible, probable, or proven invasive fungal infection (IFI) known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis)
Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis)
Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study intervention
Has a body weight of ≥500 g
The participant (or legally acceptable representative) has provided documented informed consent for the study.
Has received POS within 30 days before Day 1
Has enrolled previously in the current study and been discontinued
Has QTc prolongation at screening >500 msec
Has significant liver dysfunction
Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Has known or suspected active COVID-19 infection
Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used
Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention
Has received any listed prohibited medications within the specified timeframes before the start of study intervention
Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (Panel B)
Has suspected/proven invasive candidiasis (Panel B)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average concentration (Cavg) of single-dose IV POS (Panel A) Average concentration (Cavg) of single-dose IV POS (Panel A)
Maximum concentration (Cmax) of single-dose IV POS (Panel A) Maximum concentration (Cmax) of single-dose IV POS (Panel A)
Time to maximum concentration (Tmax) of single-dose IV POS (Panel A) Time to maximum concentration (Tmax) of single-dose IV POS (Panel A)
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A) Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A)
Clearance (CL) of single-dose IV POS (Panel A) Clearance (CL) of single-dose IV POS (Panel A)
Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A) Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A)
Cavg of multiple-dose IV POS (Panel B) Cavg of multiple-dose IV POS (Panel B)
Cmax of multiple-dose IV POS (Panel B) Cmax of multiple-dose IV POS (Panel B)
Tmax of multiple-dose IV POS (Panel B) Tmax of multiple-dose IV POS (Panel B)
AUC0-24 of multiple-dose IV POS (Panel B) AUC0-24 of multiple-dose IV POS (Panel B)
CL of multiple-dose IV POS (Panel B) CL of multiple-dose IV POS (Panel B)
Cavg of multiple-dose PFS (Panel B) Cavg of multiple-dose PFS (Panel B)
Cmax of multiple-dose PFS (Panel B) Cmax of multiple-dose PFS (Panel B)
AUC0-24 of multiple-dose PFS (Panel B) AUC0-24 of multiple-dose PFS (Panel B)
- Secondary Outcome Measures
Name Time Method Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B only) Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B only)
Percentage of participants with ≥1 adverse events (AEs) [Panels A and B] Percentage of participants with ≥1 adverse events (AEs) [Panels A and B]
Percentage of participants with ≥1 drug-related AEs (Panels A and B) Percentage of participants with ≥1 drug-related AEs (Panels A and B)
Percentage of participants discontinuing from study treatment due to AE(s) (Panels A and B) Percentage of participants discontinuing from study treatment due to AE(s) (Panels A and B)
Percentage of participants with all-cause mortality through 28 days (Panel B) Percentage of participants with all-cause mortality through 28 days (Panel B)
Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period [Panel B] Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period [Panel B]
Trial Locations
- Locations (6)
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Sint-Lambrechts-Woluwe, Belgium
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
🇵🇱Wroclaw, Poland
Ippokratio General Hospital Of Thessaloniki
🇬🇷Thessaloniki, Greece
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
🇬🇷Athens, Greece
Universitair Ziekenhuis Gent🇧🇪Gent, BelgiumCatharina DhoogeSite contact+3293324986catharina.dhooge@uzgent.be