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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2026-12-31

Brief Summary

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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).

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Detailed Description

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There are 2 panels in this study. In Panel A, POS IV will be evaluated in ≥8 participants. In Panel B, both POS IV and POS PFS will be evaluated in ≥14 participants, including ≥6 who are \<3 months of age and ≥5 who transition to the PFS formulation of POS.

Conditions

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Invasive Fungal Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panel A: POS IV

Posaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1.

Group Type EXPERIMENTAL

Posaconazole IV 6 mg/kg

Intervention Type DRUG

POS 6 mg/kg body weight by IV infusion

Panel B: POS IV

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.

Group Type EXPERIMENTAL

Posaconazole IV 6 mg/kg

Intervention Type DRUG

POS 6 mg/kg body weight by IV infusion

Panel B: POS PFS

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.

Group Type EXPERIMENTAL

Posaconazole PFS 6 mg/kg

Intervention Type DRUG

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

Interventions

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Posaconazole IV 6 mg/kg

POS 6 mg/kg body weight by IV infusion

Intervention Type DRUG

Posaconazole PFS 6 mg/kg

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

Intervention Type DRUG

Other Intervention Names

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MK-5592 NOXAFIL® SCH56592 MK-5592 NOXAFIL® SCH56592

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

San Diego, California, United States

Site Status COMPLETED

Nicklaus Children's Hospital ( Site 2109)

Miami, Florida, United States

Site Status COMPLETED

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

Chicago, Illinois, United States

Site Status RECRUITING

Duke University Medical Center ( Site 2106)

Durham, North Carolina, United States

Site Status COMPLETED

Driscoll Children's Hospital ( Site 2113)

Corpus Christi, Texas, United States

Site Status COMPLETED

UCL Saint Luc ( Site 1050)

Brussels, Bruxelles-Capitale, Region de, Belgium

Site Status RECRUITING

UZ Gent ( Site 1052)

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

UZ Leuven ( Site 1051)

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)

Athens, Attica, Greece

Site Status COMPLETED

General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)

Thessaloniki, , Greece

Site Status RECRUITING

Rambam Medical Center ( Site 1402)

Haifa, , Israel

Site Status RECRUITING

Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)

Jerusalem, , Israel

Site Status COMPLETED

Sheba Medical Center ( Site 1404)

Ramat Gan, , Israel

Site Status RECRUITING

Sourasky Medical Center ( Site 1403)

Tel Aviv, , Israel

Site Status RECRUITING

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

Mexico City, Mexico City, Mexico

Site Status RECRUITING

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

Mexico City, Mexico City, Mexico

Site Status RECRUITING

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

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)

Lima, , Peru

Site Status RECRUITING

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

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)

Olsztyn, Warmian-Masurian Voivodeship, Poland

Site Status COMPLETED

Mechnikov State Medical University ( Site 1803)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status COMPLETED

Pavlov State Medical University ( Site 1801)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status COMPLETED

Regional Children Clinical Hospital 1 ( Site 1802)

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status COMPLETED

Seoul National University Hospital-Pediatrics ( Site 2600)

Seoul, , South Korea

Site Status RECRUITING

Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status RECRUITING

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

Kiev, Kyiv Oblast, Ukraine

Site Status RECRUITING

Countries

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United States Belgium Greece Israel Mexico Peru Poland Russia South Korea Ukraine

Central Contacts

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Toll Free Number

Role: CONTACT

[email protected]

1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

312-227-6280

Study Coordinator

Role: primary

+3227646086

Study Coordinator

Role: primary

+3293324986

Study Coordinator

Role: primary

+3216343972

Study Coordinator

Role: primary

306937442644

Study Coordinator

Role: primary

+97247774512

Study Coordinator

Role: primary

+97235305046

Study Coordinator

Role: primary

+97236974521

Study Coordinator

Role: primary

5525600809

Study Coordinator

Role: primary

525539391946

Study Coordinator

Role: primary

(+52) 8183486173

Study Coordinator

Role: primary

+5112016500

Study Coordinator

Role: primary

48717332700

Study Coordinator

Role: primary

+82220723452

Study Coordinator

Role: primary

+380971550299

Study Coordinator

Role: primary

+380685949474