Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age

Phase 1

Suspended

• Conditions: Invasive Fungal Infections
• Interventions: Drug: Rezafungin Acetate

• Registration Number: NCT05534529
• Lead Sponsor: Mundipharma Research Limited

Brief Summary

This study will assess the pharmacokinetics (PK), safety, and tolerability of a single intravenous (IV) dose of rezafungin in paediatric subjects from birth to \<18 years who are receiving concomitant systemic antifungals as clinically indicated.

Detailed Description

To date, there are no clinical studies evaluating rezafungin in paediatric subjects. This study will assess the pharmacokinetics (PK), safety and tolerability of rezafungin in subjects from birth to \<18 years of age who are receiving concomitant systemic antifungal treatment as standard of care.

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-09
• Study Start: 2023-09-13
• Status Verified: 2023-12
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Primary Completion: 2027-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 32

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 invasive fungal infection (IFI) or to treat a suspected or confirmed fungal infection.

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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 hemorrhage or neuropathy, or a diagnosis of epilepsy, multiple sclerosis, or a movement disorder
• Subjects with impaired renal or hepatic functions
• Subjects with intestinal hypoxia, ischemia, necrosis, or necrotizing enterocolitis
• Subject status is unstable
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Rezafungin	Rezafungin Acetate	It is IMP.

Primary Outcome Measures

Name	Time	Method
PK	up to 30 days per patient	Tmax

Trial Locations

Locations (10)

Universitätsklinikum Essen Zentrum für Kinder- und Jugendmedizin; 🇩🇪 Essen, Germany

Universitätsklinikum Frankfurt, Goethe Universität Klinik für Kinder- und Jugendmedizin; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Münster Klinik für Kinder- und Jugendmedizin; 🇩🇪 Münster, Germany

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Universitario 12 de Octubre.; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Great Ormond Street Hospital for Children NHS Foundation Trust; 🇬🇧 London, United Kingdom

Saint Mary's Hospital, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

St. George's University Hospitals, NHS Foundation Trust; 🇬🇧 London, United Kingdom

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, United Kingdom