Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
- Conditions
- Invasive Fungal Infection
- Registration Number
- NCT04665037
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - Panel A: is undergoing treatment for possible, probable, or proven IFI known or<br> suspected to be cause by fungal pathogens against which POS has demonstrated<br> activity (which can include candidiasis)<br><br> - Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI<br> known or suspected to be cause by fungal pathogens against which POS has<br> demonstrated activity (and cannot include candidiasis)<br><br> - Has a central line (eg, central venous catheter, peripherally-inserted central<br> catheter) in place or planned to be in place before beginning IV study intervention.<br><br> - Has a body weight of =500 g<br><br> - The participant (or legally acceptable representative) has provided documented<br> informed consent for the study.<br><br>Exclusion Criteria<br><br> - Has received POS within 30 days before Day 1<br><br> - Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic<br> bronchopulmonary aspergillosis<br><br> - Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or<br> glucose-galactose malabsorption<br><br> - Has known or suspected active COVID-19 infection<br><br> - Has a known hypersensitivity or other serious adverse reaction to any azole<br> antifungal therapy, or to any other ingredient of the study intervention used<br><br> - Has any known history of torsade de pointes, unstable cardiac arrhythmia or<br> proarrhythmic conditions, a history of recent myocardial infarction, congenital or<br> acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac<br> failure within 90 days of first dose of study intervention<br><br> - Has received any listed prohibited medications within the specified timeframes<br> before the start of study intervention<br><br> - Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or<br> glucose-galactose malabsorption (Part B)<br><br> - Has suspected/proven invasive candidiasis (Part B)<br><br> - Has enrolled previously in the current study and been discontinued<br><br> - Has QTc prolongation at screening >500 msec<br><br> - Has significant liver dysfunction<br><br> - Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to<br> survive at least 5 days
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average concentration (Cavg) 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);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);Area under the plasma concentration-time curve from dosing to infinity (AUC0-8) of single-dose IV POS (Panel A);Cavg of multiple-dose IV POS (Panel B);Cmax of multiple-dose IV POS (Panel B);Tmax of multiple-dose IV POS (Panel B);AUC0-24 of multiple-dose IV POS (Panel B);CL of multiple-dose IV POS (Panel B);Cavg of multiple-dose PFS POS (Panel B);Cmax of multiple-dose PFS POS (Panel B);AUC0-24 of multiple-dose PFSPOS (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);Percentage of participants with an = 1 adverse event (AE) [Panels A and B];Percentage of participants who discontinued study therapy due to an AE (Panels A and B);Percentage of participants with a drug-related AE (Panels A and B);Percentage of participants with all-cause mortality (ACM) [Panel B];Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period (Panel B)