A Phase 1, Multicentre, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single IV Dose of Rezafungin Acetate in Paediatric Subjects from Birth to <18 Years of Age, Receiving Systemic Antifungals as Prophylaxis for Invasive Fungal Infection or to Treat a Suspected or Confirmed Fungal Infectio

Phase 1

• Conditions: Fungal infections; MedDRA version: 20.0Level: LLTClassification code: 10017534Term: Fungal infection NOS Class: 10021881; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2022-501985-23-00
• Lead Sponsor: Mundipharma Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

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

Inclusion Criteria

Male or female paediatric subjects from birth to <18 years of age who are receiving concomitant systemic antifungals (oral or IV) as prophylaxis for IFI or to treat a suspected or confirmed fungal infection.

Exclusion Criteria

History of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals and/or excipients of this formulation;, Previous or current medical conditions of severe ataxia, persistent tremors, intracranial haemorrhage or neuropathy, or a diagnosis of epilepsy, multiple sclerosis, or a movement disorder (including, but not limited to, cerebral palsy and muscular dystrophy);, Subjects with impaired renal or hepatic functions (alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal, conjugated bilirubin >24 µmol/L [1.4 mg/dL], serum creatinine >177 µmol/L [2 mg/dL], or receiving renal replacement therapy);, Subjects with intestinal hypoxia, ischaemia, necrosis, or necrotising enterocolitis;, Subject status is unstable (e.g., with sepsis or disseminated intravascular coagulation), and subject is unlikely to complete required study procedures;, Participation in another interventional treatment trial with an investigational agent or presence of an investigational device at the time of informed consent or within 28 days preceding the informed consent.

Study & Design

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