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NCT04470973: PHARAOH
Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.
trial testing Cefuroxime in Sepsis in 40 participants. Status unknown.
15 December 2023
Quick facts
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 15 July 2020 |
| Primary completion | 15 December 2023 |
| Estimated completion | 15 December 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Cefuroxime (CEFUROXIME) — full drug profile →
- Amikacin (AMIKACIN) — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
- Septic Shock — all drugs for Septic Shock →
- Infection, Bacterial — all drugs for Infection, Bacterial →
- Critically Ill — all drugs for Critically Ill →
Sponsor
Radboud University Medical Center
Who can join
18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU or the ED. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens. With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU and ED patients. A heterogeneous population of ICU and ED patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Population pharmacokinetics and optimized dosing of cefuroxime in critically ill patients.
Mouton JWA, Machiels JD, Pistorius AMA, Ter Heine R, et al · · 2025 · cited 2× · PMID 40545248 · DOI 10.1002/bcp.70144
Verify or expand the search:
- PubMed search for NCT04470973
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT04303390 — 24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis · Phase 4 · completed
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Other Radboud University Medical Center trials
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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 NCT04470973 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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: 10 September 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/NCT04470973.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing