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NCT04777058: ICONIC
Pharmacokinetics of Isavuconazole in Patients in the Intensive Care Unit
trial in Invasive Fungal Infections in 20 participants. Completed in 29 September 2022.
29 September 2022
Quick facts
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 1 March 2021 |
| Primary completion | 29 September 2022 |
| Estimated completion | 29 September 2022 |
| Sites | 4 locations across Belgium, Netherlands |
Conditions studied
- Invasive Fungal Infections — all drugs for Invasive Fungal Infections →
- Pharmacokinetics — all drugs for Pharmacokinetics →
- Intensive Care Unit — all drugs for Intensive Care Unit →
Sponsor
Radboud University Medical Center
Who can join
18 and older, any sex, with Invasive Fungal Infections or Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
20 patients admitted to the ICU department and receiving isavuconazole as part of standard care for the treatment of fungal infections will be included in the study. Between day 3 and 7, 8 samples will be collected at t = 0 (pre-dose), and t = 0.5, 1, 2, 4, 6, 8 and 12 hours after end of infusion to obtain a PK curve. An optional, additional sample can be collected after discontinuation of isavuconazole therapy if possible. Total and free isavuconazole 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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies.
Jansen AME, Mertens B, Spriet I, Verweij PE, et al · · 2023 · cited 13× · PMID 37819503 · DOI 10.1007/s40262-023-01305-8 -
The impact of extracorporeal membrane oxygenation on the exposure to isavuconazole: a plea for thorough pharmacokinetic evaluation.
Mertens B, Wauters J, Debaveye Y, Van Regenmortel N, et al · · 2022 · cited 13× · PMID 35897020 · DOI 10.1186/s13054-022-04093-y -
Isavuconazole Exposure in Critically Ill Patients Treated with Extracorporeal Membrane Oxygenation: Two Case Reports and a Narrative Literature Review.
Mertens B, Elkayal O, Dreesen E, Wauters J, et al · · 2023 · cited 9× · PMID 37508181 · DOI 10.3390/antibiotics12071085
Verify or expand the search:
- PubMed search for NCT04777058
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Radboud University Medical Center trials
Trials by the same sponsor.
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- NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
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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 NCT04777058 (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: 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/NCT04777058.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing