Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Invasive Aspergillosis

Treatments: Drug: Posaconazole PFS; Drug: Posaconazole IV; Drug: Posaconazole tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04218851

MK-5592-104 (Other Identifier)

2019-002267-10 (EudraCT Number)

5592-104

Details and patient eligibility

About

This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS) intravenous (IV) and oral formulations in pediatric participants 2 to <18 years of age with invasive aspergillosis (IA).

Enrollment: 31 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a diagnosis of possible, probable, or proven IA per modified 2008/2020 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) disease definitions
• Has one or more of pre-defined risks as per modified 2008 EORTC/MSG disease definitions
• Has a central line (e.g., central venous catheter, peripherally-inserted central catheter) in place or planned to be in place prior to beginning IV study treatment.
• Has clinical symptoms consistent with an acute episode of IA, defined as duration of clinical syndrome of <30 days.
• Participants weigh at least 10 kg, and may be of any race/ethnicity.
• During the intervention period and for at least 30 days after the last dose of study treatment, males agree to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
• Female is not pregnant or breastfeeding, and is not a woman of child bearing potential (WOCBP) or is a WOCBP using a highly effective contraceptive method. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.

Exclusion criteria

• Has chronic (≥30 days' duration) IA, relapsed/recurrent IA, or refractory IA that has not responded to prior antifungal treatment.
• Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
• Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study treatment 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 prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of time of first dose of study treatment.
• Has known hereditary fructose intolerance.
• Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
• Is on artificial ventilation at the time of first dose of study treatment.
• Has received any treatment prohibited by the protocol.
• Has enrolled previously in the current study and been discontinued.
• Is not expected, in the opinion of the investigator, to survive for at least 1 month after the initiation of study treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Posaconazole

Experimental group

Description:

On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.

Treatment:

Drug: Posaconazole tablet

Drug: Posaconazole IV

Drug: Posaconazole PFS