Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
2
Fungal infection
To establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years.
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 2 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518305-17-01
- EudraCT number
- 2021-006868-24
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years.
Secondary objectives 2
- To explore the role of renal function on the clearance of fluconazole
- To explore the bioavailability of oral fluconazole versus intravenous fluconazole in paediatric patients.
Conditions and MedDRA coding
Fungal infection
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518305-17-00 | Pharmacokinetics of fluconazole given orally or intravenously as prophylaxis or therapy to children and adolescents with invasive fungal infections (FOCUS) | Radboud universitair medisch centrum Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Subject is treated with fluconazole for prophylaxis or treatment of an invasive fungal infection;
- Subject is 2 - 18 years of age on the day of the first fluconazole dosing
- Subject is managed with a central venous catheter or arterial line from which blood can be obtained
Exclusion criteria 2
- Subject is managed by means of an extracorporeal clearance technique
- Subject has previously participated in this study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary objective of this study is to establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years, we aim to describe fluconazole pharmacokinetics in this patient population by means of population pharmacokinetic (pop-PK) modelling. The pharmacokinetic parameters of the developed pop-PK model are among others, clearance (CL), volume of distribution (Vd) and exposure described by the area under the concentration-time curve (AUC).
Secondary endpoints 1
- Other study parameters are factors that might influence the primary study parameters, the covariates. Since this is an observational study, potential covariates will only be explored. Covariates of interest are renal clearance and body weight. Another study parameter that will be explored is the oral bioavailability (F) of fluconazole, which is the percentage of the drug that is systemically available after oral administration compared to the exposure after intravenous administration.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Diflucan I.V. 2 mg/ml, oplossing voor infusie
PRD3224693 · Product
- Active substance
- Fluconazole
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 365 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J02AC01 — FLUCONAZOLE
- Marketing authorisation
- RVG 14769
- MA holder
- PFIZER B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Diflucan 100 mg, capsule, hard
PRD497560 · Product
- Active substance
- Fluconazole
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 365 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J02AC01 — FLUCONAZOLE
- Marketing authorisation
- RVG 14767
- MA holder
- PFIZER B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Diflucan 10 mg/ml, poeder voor orale suspensie
PRD498024 · Product
- Active substance
- Fluconazole
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 365 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J02AC01 — FLUCONAZOLE
- Marketing authorisation
- RVG 15757
- MA holder
- PFIZER B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluconazol Accord 50 mg capsules, hard
PRD1993620 · Product
- Active substance
- Fluconazole
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 365 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J02AC01 — FLUCONAZOLE
- Marketing authorisation
- RVG 109167
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Roger Brüggemann
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Roger Brüggemann
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 30 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-12-02 | 2024-12-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-518305-17-01 | 4 |
| Recruitment arrangements (for publication) | K1_blank_document_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SISandICF_12-16_PMC | 2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_12-16_RUMC | 2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_adults_parents_PMC | 3 |
| Subject information and informed consent form (for publication) | L1_SISandICF_adults_parents_RUMC | 3 |
| Subject information and informed consent form (for publication) | L1_SISbelow12_PMC | 3 |
| Subject information and informed consent form (for publication) | L1_SISbelow12_RUMC | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fluconazole_Capsule | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_fluconazole_intravenous | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_fluconazole_suspension | 1 |
| Synopsis of the protocol (for publication) | D1_NL-NL_protocolsynopsis_2024-518305-17-01 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-16 | Netherlands | Acceptable 2024-12-02
|
2024-12-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-14 | Netherlands | Acceptable 2026-06-03
|
2026-06-03 |