Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04665037 | Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127) | PHASE2 | RECRUITING | 40 | — | — | Feb 22, 2022 | Dec 31, 2026 | Sep 18, 2025 | 26 | United States, Belgium +8 |
The Cavg of IV POS is based on population PK analysis.
The Cmax of IV POS is based on population PK analysis.
The Tmax of IV POS is based on population PK analysis.
The AUC 0-24 of IV POS is based on population PK analysis.
The clearance (CL) of IV POS is based on population PK analysis.
The AUC0-∞ of IV POS is based on population PK analysis.
The Cavg of IV POS is based on population PK analysis.
The Cmax of IV POS is based on population PK analysis.
The Tmax of IV POS is based on population PK analysis.
The AUC0-24 of IV POS is based on population PK analysis.
The CL of IV POS is based on population PK analysis.
The Cavg of PFS POS is based on population PK analysis.
The Cmax of PFS POS is based on population PK analysis.
The AUC0-24 of PFS POS is based on population PK analysis.
| Arm | Type | Description |
|---|---|---|
| Panel A: POS IV | EXPERIMENTAL | Posaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Posaconazole IV 6 mg/kg | DRUG | POS 6 mg/kg body weight by IV infusion |
| Posaconazole PFS 6 mg/kg | DRUG | POS nominal 6 mg/kg body weight based on weight bands taken orally |
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 pro...