Posaconazole (MK-5592) IV and oral in children less than 2 years of age with invasive fungal infectio

Phase 1

• Conditions: Invasive Fungal Infection; MedDRA version: 20.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-003842-34-PL
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-03
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Panel A Participants Only
1. Is undergoing treatment for possible, probable, or proven IFI known or suspected to be caused by fungal pathogens against which POS has demonstrated activity (which can include candidiasis) per the modified 2008 EORTC/MSG consensus criteria

Panel B Participants Only
2. Has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be caused by fungal pathogens against which POS has demonstrated activity (see Appendix 8 of the protocol for diagnostic guidance per the modified 2020 EORTC/MSG consensus criteria)

Panel A and Panel B Participants
3. Has a central line (eg, central venous catheter, peripherally inserted central catheter) in place or planned to be in place before beginning IV study intervention
4. Is male or female, from birth to <2 years of age at the time of first dose of study intervention
5. Has a body weight of =500 g
6. The participant (or legally acceptable representative) has provided documented informed consent for the study

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Panel A and B Participants
1. Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
2. Has known or suspected active COVID-19 infection.
3. Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study
intervention used
4. 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
5. Has any condition that, in the opinion of the investigator, may interfere with optimal participation in the study

Panel B Participants Only
6. Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
7. Has suspected/proven invasive candidiasis.

Panel A Participants Only
8. Has received any treatment specifically listed in the protocol within the specified time period before the start of study intervention

Panel B Participants Only
9. Has received any treatment specifically listed in the protocol within the specified time period before the start of study intervention.

Panel A and Panel B Participants
10. Has enrolled previously in the current study and been discontinued
11. Has QTc prolongation (based on either Fridericia or Bazett's correction) at screening >500 msec
12. Has significant liver dysfunction at screening, defined as:
- Total bilirubin >1.5 × ULN and AST or ALT >3 × ULN with normal alkaline phosphatase
13. Has calculated creatinine clearance <20 mL/min/1.73 m2 (modified Schwartz formula) at screening
14. Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
15. Has an immediate family member (eg, parent/legal guardian, sibling) who is investigational site or Sponsor staff directly involved with this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified