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NCT04995835
Cefiderocol PK in Patients on ECMO
Phase 1 trial testing Cefiderocol in Sepsis in 5 participants. Completed in 1 September 2024.
1 June 2024
Quick facts
| Lead sponsor | Joseph L. Kuti, PharmD |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 5 |
| Start date | 16 July 2021 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 September 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Cefiderocol (CEFIDEROCOL) — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
Sponsor
Joseph L. Kuti, PharmD — full company profile →
Who can join
18 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving ECMO.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Treatment of critically ill patients with cefiderocol for infections caused by multidrug-resistant pathogens: review of the evidence.
Viale P, Sandrock CE, Ramirez P, Rossolini GM, et al · · 2023 · cited 41× · PMID 37322293 · DOI 10.1186/s13613-023-01146-5 -
Real-Life Data on the Effectiveness and Safety of Cefiderocol in Severely Infected Patients: A Case Series.
Fendian ÁM, Albanell-Fernández M, Tuset M, Pitart C, et al · · 2023 · cited 15× · PMID 36943617 · DOI 10.1007/s40121-023-00776-3 -
Therapeutic challenges and emerging strategies against carbapenem-resistant <i>Acinetobacter baumannii</i>.
Yang C, Li J, Luo X, Song Z, et al · · 2026 · PMID 41907167 · DOI 10.1016/j.crmicr.2026.100581
Verify or expand the search:
- PubMed search for NCT04995835
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cefiderocol
Trials testing the same drug.
- NCT07465432 — Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries · Phase 4 · recruiting
- NCT07004049 — Optimising TREATment for Severe Gram-Negative Bacterial Infections · Phase 4 · recruiting
- NCT06547554 — A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants · Phase 1 · completed
- NCT06086626 — A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants · Phase 2 · completed
- NCT05789199 — Use of Cefiderocol in the Management of Gram-Negative Infections · completed
Other recruiting trials for Sepsis
Currently open trials in the same condition.
- NCT07507877 — Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness · recruiting
- NCT07154615 — Assessing Immune Dysfunction in Sepsis · recruiting
- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07351344 — African Survey on Sepsis Knowledge (ASK) · recruiting
- NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
Other Joseph L. Kuti, PharmD trials
Trials by the same sponsor.
- NCT04493151 — Imipenem/Cilastatin/Relebactam PK in ECMO · Phase 1 · completed
- NCT03172793 — Telavancin Pharmacokinetics in Cystic Fibrosis Patients · Phase 4 · completed
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 NCT04995835 (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 Joseph L. Kuti, PharmD
- Last refreshed: 16 December 2024
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/NCT04995835.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing