Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)

NCT04665037 | Recruiting Phase 2 DMC FDA Drug

• 6 other identifiers: 5592-127MK-5592-127PHRR230411-0055892023-505613-24-00U1111-1292-11902019-003842-34
• Study Type: interventional
• Target: 40
• Locations: 10 countries
• Sites: 26

Brief 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).

Conditions

Invasive Fungal Infection

Outcome Measures

Primary Outcomes (14)

• 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.

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

• Cmax of multiple-dose IV POS (Panel B)

  The Cmax of IV POS is based on population PK analysis.

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

• Tmax of multiple-dose IV POS (Panel B)

  The Tmax of IV POS is based on population PK analysis.

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

• AUC0-24 of multiple-dose IV POS (Panel B)

  The AUC0-24 of IV POS is based on population PK analysis.

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

• CL of multiple-dose IV POS (Panel B)

  The CL of IV POS is based on population PK analysis.

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

• Cavg of multiple-dose PFS POS (Panel B)

  The Cavg of PFS POS is based on population PK analysis.

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

• Cmax of multiple-dose PFS POS (Panel B)

  The Cmax of PFS POS is based on population PK analysis.

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

• AUC0-24 of multiple-dose PFSPOS (Panel B)

  The AUC0-24 of PFS POS is based on population PK analysis.

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

Secondary Outcomes (6)

• Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B)

  Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

• Percentage of participants with an ≥ 1 adverse event (AE) [Panels A and B]

  Up to 98 days

• Percentage of participants who discontinued study therapy due to an AE (Panels A and B)

  Up to 84 days

• Percentage of participants with a drug-related AE (Panels A and B)

  Up to 98 days

• Percentage of participants with all-cause mortality (ACM) [Panel B]

  Up to 28 days

Study Arms (3)

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

Interventions

Posaconazole IV 6 mg/kg DRUG

POS 6 mg/kg body weight by IV infusion

Also known as: MK-5592, NOXAFIL®, SCH56592

Panel A: POS IV; Panel B: POS IV

Posaconazole PFS 6 mg/kg DRUG

POS nominal 6 mg/kg body weight based on weight bands taken orally

Also known as: MK-5592, NOXAFIL®, SCH56592

Panel B: POS PFS

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (26)

Rady Children's Hospital-San Diego ( Site 2101)

San Diego, California, 92123, United States

COMPLETED

Nicklaus Children's Hospital ( Site 2109)

Miami, Florida, 33155, United States

COMPLETED

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)

Chicago, Illinois, 60611, United States

RECRUITING

Duke University Medical Center ( Site 2106)

Durham, North Carolina, 27710, United States

COMPLETED

Driscoll Children's Hospital ( Site 2113)

Corpus Christi, Texas, 78411, United States

COMPLETED

UCL Saint Luc ( Site 1050)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

RECRUITING

UZ Gent ( Site 1052)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UZ Leuven ( Site 1051)

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)

Athens, Attica, 115 27, Greece

COMPLETED

General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)

Thessaloniki, 546 42, Greece

RECRUITING

Rambam Medical Center ( Site 1402)

Haifa, 3109601, Israel

RECRUITING

Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)

Jerusalem, 9112001, Israel

COMPLETED

Sheba Medical Center ( Site 1404)

Ramat Gan, 5265601, Israel

RECRUITING

Sourasky Medical Center ( Site 1403)

Tel Aviv, 6423906, Israel

RECRUITING

Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)

Mexico City, Mexico City, 04530, Mexico

RECRUITING

Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)

Mexico City, Mexico City, 06720, Mexico

RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203)

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)

Lima, 15038, Peru

RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

RECRUITING

Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)

Olsztyn, Warmian-Masurian Voivodeship, 10-561, Poland

COMPLETED

Mechnikov State Medical University ( Site 1803)

Saint Petersburg, Sankt-Peterburg, 194291, Russia

COMPLETED

Pavlov State Medical University ( Site 1801)

Saint Petersburg, Sankt-Peterburg, 197022, Russia

COMPLETED

Regional Children Clinical Hospital 1 ( Site 1802)

Yekaterinburg, Sverdlovsk Oblast, 620149, Russia

COMPLETED

Seoul National University Hospital-Pediatrics ( Site 2600)

Seoul, 03080, South Korea

RECRUITING

Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014, Ukraine

RECRUITING

NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)

Kiev, Kyiv Oblast, 01135, Ukraine

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 11, 2020
• Study Start: February 22, 2022
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (5); ME (3); GR (2); PL (2); PE (1); RU (3); IL (4); UA (2); BE (3); KR (1)