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

  • STATUS
    Recruiting
  • End date
    Feb 6, 2023
  • participants needed
    30
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 September 2021
cancer
fungal infection
posaconazole

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).

Details
Condition Invasive Aspergillosis
Treatment Posaconazole IV, Posaconazole PFS, Posaconazole tablet
Clinical Study IdentifierNCT04218851
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 September 2021

Eligibility

Yes No Not Sure

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
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