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NCT05130723: FOCUS
Pharmacokinetics of Fluconazole in Children (2-18 Years)
trial in Invasive Fungal Infections in 30 participants. Status unknown.
1 October 2023
Quick facts
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 18 October 2022 |
| Primary completion | 1 October 2023 |
| Estimated completion | 1 October 2023 |
| Sites | 2 locations across Netherlands |
Conditions studied
- Invasive Fungal Infections — all drugs for Invasive Fungal Infections →
Sponsor
Radboud University Medical Center
Who can join
Adults 2 to 18, any sex, with Invasive Fungal Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
30 pediatric patients aged 2-18 years receiving fluconazole as part of standard care for the treatment or prophylaxis of an invasive fungal infection will be included in the study. Between day 2 and 10, 6 samples will be collected on two days. In the case a patient switches from oral to intravenous therapy, an additional PK-day consisting of 3 samples will be scheduled. Fluconazole plasma concentrations will be determined. A pharmacokinetic model will be fitted to the data from all individuals simultaneously. Data will be analysed using non-linear mixed effects modelling (NONMEM). Monte Carlo simulations will guide the establishment of an improved fluconazole dosing regimen for pediatric and adolescent patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05130723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Radboud University Medical Center trials
Trials by the same sponsor.
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- NCT07530263 — Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) · Phase 1 · not yet recruiting
- NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
- NCT07504172 — Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05130723 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
- Last refreshed: 26 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05130723.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing