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NCT03246386: DONUT
Dosing Obese With Noxafil® Under a Trial (DONUT)
Phase 4 trial testing Posaconazole Injection [Noxafil] 300mg in Morbid Obesity in 24 participants. Completed in 1 September 2018.
1 September 2018
Quick facts
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 5 November 2017 |
| Primary completion | 1 September 2018 |
| Estimated completion | 1 September 2018 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- Posaconazole Injection [Noxafil] 300mg — full drug profile →
- Posaconazole Injection [Noxafil] 400mg — full drug profile →
Conditions studied
- Morbid Obesity — all drugs for Morbid Obesity →
Sponsor
Radboud University Medical Center
Who can join
Adults 18 to 65, any sex, with Morbid Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Although posaconazole is approved for the prophylaxes and treatment of invasive fungal infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not specified. There is clear evidence indicating that heavier patients are receiving a sub-optimal dose if the current guidelines are used. Specifically in the setting of augmented prevalence of species with intermediate susceptible to posaconazole, adequate dosing is needed at start of treatment. Therefore it seems prudent to conduct a trial in a cohort of obese patients who receive posaconazole (300mg or 400mg) and define the pharmacokinetics. These will then be compared to the pharmacokinetics in a normal-weight group receiving 300mg posaconazole.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Implications for IV posaconazole dosing in the era of obesity.
Wasmann RE, Smit C, van Donselaar MH, van Dongen EPA, et al · · 2020 · cited 22× · PMID 31971567 · DOI 10.1093/jac/dkz546
Verify or expand the search:
- PubMed search for NCT03246386
- 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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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 NCT03246386 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- 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: 19 October 2020
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/NCT03246386.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing