Clinical Trials in Belgium / NCT04665037
Recruiting
Phase 2
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
NCT04665037 · tracked via the Priya Life Science Belgium tracker
Condition(s) studied
Invasive Fungal Infection
Investigational drug(s) / intervention(s)
Posaconazole IV 6 mg/kg: POS 6 mg/kg body weight by IV infusion
Posaconazole PFS 6 mg/kg: POS nominal 6 mg/kg body weight based on weight bands taken orally
Study summary
This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants \<2 years of age with invasive fungal infection (IFI).
Eligibility
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
Primary outcome measure(s)
- Average concentration (Cavg) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1
The Cavg of IV POS is based on population PK analysis. - Maximum concentration (Cmax) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1
The Cmax of IV POS is based on population PK analysis. - Time to maximum concentration (Tmax) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1
The Tmax of IV POS is based on population PK analysis. - Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1
The AUC 0-24 of IV POS is based on population PK analysis. - Clearance (CL) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1
The clearance (CL) of IV POS is based on population PK analysis. - Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1
The AUC0-∞ of IV POS is based on population PK analysis. - Cavg of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cavg of IV POS is based on population PK analysis. - Cmax of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cmax of IV POS is based on population PK analysis. - Tmax of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Tmax of IV POS is based on population PK analysis. - AUC0-24 of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The AUC0-24 of IV POS is based on population PK analysis. - CL of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The CL of IV POS is based on population PK analysis. - Cavg of multiple-dose PFS POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cavg of PFS POS is based on population PK analysis. - Cmax of multiple-dose PFS POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cmax of PFS POS is based on population PK analysis. - AUC0-24 of multiple-dose PFSPOS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The AUC0-24 of PFS POS is based on population PK analysis.
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Rady Children's Hospital-San Diego ( Site 2101) | San Diego | California | Completed |
| Nicklaus Children's Hospital ( Site 2109) | Miami | Florida | Completed |
| Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104) | Chicago | Illinois | Recruiting |
| Duke University Medical Center ( Site 2106) | Durham | North Carolina | Completed |
| Driscoll Children's Hospital ( Site 2113) | Corpus Christi | Texas | Completed |
| UCL Saint Luc ( Site 1050) | Brussels | Bruxelles-Capitale, Region de | Recruiting |
| UZ Gent ( Site 1052) | Ghent | Oost-Vlaanderen | Recruiting |
| UZ Leuven ( Site 1051) | Leuven | Vlaams-Brabant | Recruiting |
| Athens Childrens Hospital Aglaia Kyriakou ( Site 1102) | Athens | Attica | Completed |
| General Hospital of Thessaloniki "Ippokrateio" ( Site 1100) | Thessaloniki | Greece | Recruiting |
| Rambam Medical Center ( Site 1402) | Haifa | Israel | Recruiting |
| Hadassah Ein Karem Hebrew University Medical Center ( Site 1401) | Jerusalem | Israel | Completed |
| Sheba Medical Center ( Site 1404) | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center ( Site 1403) | Tel Aviv | Israel | Recruiting |
| Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200) | Mexico City | Mexico City | Recruiting |
| Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202) | Mexico City | Mexico City | Recruiting |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203) | Monterrey | Nuevo León | Recruiting |
| Instituto Nacional de Enfermedades Neoplasicas ( Site 1601) | Lima | Peru | Recruiting |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708) | Wroclaw | Lower Silesian Voivodeship | Recruiting |
| Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705) | Olsztyn | Warmian-Masurian Voivodeship | Completed |
| Mechnikov State Medical University ( Site 1803) | Saint Petersburg | Sankt-Peterburg | Completed |
| Pavlov State Medical University ( Site 1801) | Saint Petersburg | Sankt-Peterburg | Completed |
| Regional Children Clinical Hospital 1 ( Site 1802) | Yekaterinburg | Sverdlovsk Oblast | Completed |
| Seoul National University Hospital-Pediatrics ( Site 2600) | Seoul | South Korea | Recruiting |
| Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | Recruiting |
| NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912) | Kiev | Kyiv Oblast | Recruiting |
More Merck Sharp & Dohme LLC trials in Belgium
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04665037 on ClinicalTrials.gov ↗ ← All trials in Belgium