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

• Status: Recruiting
• Trial end date: 2023-02-06
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Posaconazole

Criteria

Inclusion Criteria:

• Has a diagnosis of possible, probable, or proven IA per modified 2008 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

• Meets pre-defined mycologic and clinical criteria as per modified 2008 EORTC/MSG disease definitions

• Has demonstrated fungal elements (by cytology or microscopy) or positive culture for Aspergillus obtained by sterile sampling of disease tissue as per modified 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.

• 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 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 a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

• Is on artificial ventilation or receiving acute continuous positive airway pressure (CPAP)/bilevel positive airway pressure (BPAP) at the time of first dose of study treatment.

• Has known or suspected Gilbert's disease.

• 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.