A PHASE 2, OPEN-LABEL, SINGLE-ARM, SEQUENTIAL-PANEL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF POSACONAZOLE (POS, MK-5592) INTRAVENOUS AND POWDER FOR ORAL SUSPENSION FORMULATIONS IN PEDIATRIC PARTICIPANTS FROM BIRTH TO <2 YEARS OF AGE WITH POSSIBLE, PROBABLE, OR PROVEN INVASIVE FUNGAL INFECTION.

Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,0 个研究点目标入组 0 人开始时间: 2020年12月7日最近更新: 2024年8月20日

适应症

试验速览

阶段: 未知
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1.- Panel A only: Is undergoing treatment for IFI (and can include candidiasis). Note: Participants can be receiving treatment for candidiasis.
•2.- Panel B only: * Has a diagnosis of possible, probable, or proven IFI (and cannot include candidiasis) per the modified 2008 EORTC/MSG consensus criteria. * If enrolled with a possible or probable IFI diagnosis, has one or more risks as per the modified 2008 EORTC/MSG consensus criteria. * If enrolled with a possible or probable IFI diagnosis, meets mycologic and clinical criteria as per the modified 2008 EORTC/MSG consensus criteria. * If enrolled with a proven IFI diagnosis, has shown fungal elements or positive culture for a fungal pathogen obtained by sterile sampling of diseased tissue as per the modified 2008 EORTC/MSG consensus criteria. * Has clinical symptoms consistent with an acute episode of IFI (duration of clinical syndrome of <30 days).
•3.- Panel A and B: * Has a central line in place or planned to be in place prior to beginning IV study intervention. * Is male or female, from birth to <2 years of age at the time of first dose of study treatment. * Has a body weight ≥500g. * The participant’s legally acceptable representative provides written informed consent for the study.
•Please refer to the protocol for more information

排除标准

•1.- Panel A only: Has received POS within 30 days before Day 1.
•2.- Panel B only: * 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. * 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 intervention. * Has chronic (≥30 days’ duration) IFI, relapsed/recurrent IFI, or refractory IFI that has not responded to prior antifungal treatment. * Has invasive candidiasis.
•3.- Panel A and B: * 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 prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention. * Has known or suspected Gilbert’s disease. * Has any condition that, in the opinion of the investigator, may interfere with optimal participation in the study. * Has received any treatment specifically listed in Table 1 within the specified timeframes before the start of study intervention. * Has enrolled previously in the current study and been discontinued. * Has QTc prolongation (based on either Fridericia or Bazett’s correction) at screening >500 msec. * Has significant liver dysfunction (defined as total bilirubin >1.5 times ULN AND AST or ALT >3 times ULN with normal alkaline phosphatase) OR AST or ALT >5 times ULN. * Has calculated creatinine clearance <20 mL/min (Cockroft-Gault formula) or <20 mL/min/1.73m2 (modified Schwartz formula) at screening. * Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days. *Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
•Please refer to the protocol for more information.

研究者

发起方

Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,

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