Posaconazole (MK-5592) Intravenous and Oral in Children (... | NCT04665037

ID	Type	Description
MK-5592-127	Other Identifier	MSD
PHRR230411-005589	Registry Identifier	PHRR
2023-505613-24-00	Registry Identifier	EU CT
U1111-1292-1190	Registry Identifier	UTN
2019-003842-34	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Panel A: POS IV	Experimental	Posaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1.	Drug: Posaconazole IV 6 mg/kg
Panel B: POS IV	Experimental	Posaconazole 6 mg/kg body weight administered twice daily by IV infusion on Day 1, and then once daily from Day 2 to a maximum 84 days.	Drug: Posaconazole IV 6 mg/kg
Panel B: POS PFS	Experimental	Following a minimum of 7 days IV dosing, participants as clinically able will be transitioned from POS IV to POS PFS nominal 6 mg/kg body weight based on weight bands administered on Day 8, once daily to a maximum 84 days.	Drug: Posaconazole PFS 6 mg/kg

Name	Type	Description	Arm Group Labels	Other Names
Posaconazole IV 6 mg/kg	Drug	POS 6 mg/kg body weight by IV infusion	Panel A: POS IV Panel B: POS IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average concentration (Cavg) of single-dose IV POS (Panel A)	The Cavg of IV POS is based on population PK analysis.	Predose, 0.25 and 24 hours post-infusion on Day 1
Maximum concentration (Cmax) of single-dose IV POS (Panel A)	The Cmax of IV POS is based on population PK analysis.	Predose, 0.25 and 24 hours post-infusion on Day 1
Time to maximum concentration (Tmax) of single-dose IV POS (Panel A)	The Tmax of IV POS is based on population PK analysis.	Predose, 0.25 and 24 hours post-infusion on Day 1
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A)	The AUC 0-24 of IV POS is based on population PK analysis.	Predose, 0.25 and 24 hours post-infusion on Day 1
Clearance (CL) of single-dose IV POS (Panel A)	The clearance (CL) of IV POS is based on population PK analysis.	Predose, 0.25 and 24 hours post-infusion on Day 1
Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A)	The AUC0-∞ of IV POS is based on population PK analysis.	Predose, 0.25 and 24 hours post-infusion on Day 1
Cavg of multiple-dose IV POS (Panel B)	The Cavg of IV POS is based on population PK analysis.

Secondary Outcomes

Measure	Description	Time Frame
Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B)	The Cavg of IV POS is based on population PK analysis. Comparisons between participants in Panel B will be made to data that was previously collected in older participants.	Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Panel A: is undergoing treatment for possible, probable, or proven 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.

Exclusion Criteria

Has received POS within 30 days before Day 1
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 (Part B)
Has suspected/proven invasive candidiasis (Part B)
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

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections