Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age
Primary Purpose
Invasive Fungal Infections
Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Rezafungin Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Fungal Infections
Eligibility Criteria
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.
Sites / Locations
- Universitätsklinikum Essen Zentrum für Kinder- und Jugendmedizin
- Universitätsklinikum Frankfurt, Goethe Universität Klinik für Kinder- und Jugendmedizin
- Universitätsklinikum Münster Klinik für Kinder- und Jugendmedizin
- Hospital Universitario de Burgos
- Hospital Universitario 12 de Octubre.
- Hospital Universitario La Paz
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Saint Mary's Hospital, Imperial College Healthcare NHS Trust
- St. George's University Hospitals, NHS Foundation Trust
- Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rezafungin
Arm Description
It is IMP.
Outcomes
Primary Outcome Measures
PK
Cmax
PK
Tmax
Secondary Outcome Measures
Full Information
NCT ID
NCT05534529
First Posted
September 1, 2022
Last Updated
August 25, 2023
Sponsor
Mundipharma Research Limited
1. Study Identification
Unique Protocol Identification Number
NCT05534529
Brief Title
Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Fungal Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rezafungin
Arm Type
Experimental
Arm Description
It is IMP.
Intervention Type
Drug
Intervention Name(s)
Rezafungin Acetate
Other Intervention Name(s)
Rezafungin
Intervention Description
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.
Primary Outcome Measure Information:
Title
PK
Description
Cmax
Time Frame
up to 30 days per patient
Title
PK
Description
Tmax
Time Frame
up to 30 days per patient
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universitätsklinikum Essen Zentrum für Kinder- und Jugendmedizin
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Frankfurt, Goethe Universität Klinik für Kinder- und Jugendmedizin
City
Frankfurt
Country
Germany
Facility Name
Universitätsklinikum Münster Klinik für Kinder- und Jugendmedizin
City
Münster
Country
Germany
Facility Name
Hospital Universitario de Burgos
City
Burgos
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre.
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Great Ormond Street Hospital for Children NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Saint Mary's Hospital, Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Facility Name
St. George's University Hospitals, NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age
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