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

Invasive Fungal Infections Clinical Trial

Official title:

A Phase 1, Multicentre, Open-Label Study to Evaluate the PK, Safety, and Tolerability of a Single IV Dose of Rezafungin in Paediatric Subjects, Receiving Systemic Antifungals as Prophylaxis for IFI or to Treat a Suspected or Confirmed FI

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05534529
• Other study ID #: MR907-1501
• Status: Suspended
• Phase: Phase 1
• Start date: September 13, 2023
• Est. completion date: December 2027

Study information

• Verified date: December 2023
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 32
• Est. completion date: December 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Rezafungin Acetate
This is a Phase 1, multicentre, open-label, single-dose study. The study will be conducted at 10 sites across at least 3 countries in Europe.

Locations

Country	Name	City	State
Germany	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
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Universitario 12 de Octubre.	Madrid
Spain	Hospital Universitario La Paz	Madrid
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK	Cmax	up to 30 days per patient
Primary	PK	Tmax	up to 30 days per patient