B48 Other mycoses, not elsewhere classified Other mycoses, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive Statistics NAME OF THE RESULT: Cavg, Cmax, Tmax, CL, AUC0-8 based on population PK analysis (Panel A) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 1;Descriptive Statistics NAME OF THE RESULT: Cavg, Cmax, Tmax, CL, AUC0-24 based on population PK analysis (Panel B) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During treatment period (IV and oral treatment phases) | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive Statistics NAME OF THE RESULT: Cavg, Cmax, Tmax, CL, AUC0-8 based on population PK analysis (Panel A) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 1;Descriptive Statistics NAME OF THE RESULT: Cavg, Cmax, Tmax, CL, AUC0-24 based on population PK analysis (Panel B) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During treatment period (IV and oral treatment phases);Descriptive Statistics NAME OF THE RESULT: Proportion of adverse events (AE), Discontinuation of study intervention due to AEs and drug-related AEs PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From the treatment period (IV and oral treatment phases) plus 14 days of follow-up. | — |
Countries
Belgium, Greece, Israel, Peru, Poland, Russian Federation, United Kindgdom, United States
Outcome results
None listed