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NCT04170309: RETRACE
Collection of Data of Ceftobiprole Treated Patients: Comparison of Patients With and Without Certain Diseases
trial testing Ceftobiprole medocaril in Renal Insufficiency in 428 participants. Completed in 9 June 2023.
9 June 2023
Quick facts
| Lead sponsor | Advanz Pharma |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 428 |
| Start date | 30 March 2020 |
| Primary completion | 9 June 2023 |
| Estimated completion | 9 June 2023 |
| Sites | 18 locations across France, Spain, Germany, Italy |
Drugs / interventions tested
- Ceftobiprole medocaril (Ceftobiprole medocaril) — full drug profile →
Conditions studied
- Renal Insufficiency — all drugs for Renal Insufficiency →
- Hepatic Insufficiency — all drugs for Hepatic Insufficiency →
- Immunosuppression — all drugs for Immunosuppression →
Sponsor
Advanz Pharma — full company profile →
Who can join
18 and older, any sex, with Renal Insufficiency or Hepatic Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this observational study, data from patients treated with the antibiotic ceftobiprole in the past will be collected. The sponsor of the study is Correvio International Sárl, based in Switzerland. Correvio has committed to the health authorities to obtain further information on possible side effects especially in patients suffering from impaired liver or renal function or immune system deficiency and compare these effects to the ones observed in patients without these health problems. Patient data are collected from historic patient charts, patients will not be treated for the purpose of this data collection. All efforts are being made to capture the data of all patients who meet the inclusion criteria and have received at least one dose of ceftobiprole since this drug was first prescribed at the site.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety of ceftobiprole in patients with impaired renal, hepatic or immune function: A multinational retrospective hospital chart review (RETRACE study).
Membrillo de Novales FJ, Falcone M, Soriano A, Fernández-Hidalgo N, et al · · 2025 · cited 2× · PMID 39864599 · DOI 10.1016/j.ijantimicag.2025.107450
Verify or expand the search:
- PubMed search for NCT04170309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ceftobiprole medocaril
Trials testing the same drug.
- NCT05856227 — Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age · Phase 3 · completed
- NCT03138733 — Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia · Phase 3 · completed
- NCT02527681 — Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics · Phase 1 · terminated
Other recruiting trials for Renal Insufficiency
Currently open trials in the same condition.
- NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
- NCT07001436 — A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insuffici · Phase 1 · recruiting
- NCT06431789 — Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in P · recruiting
- NCT06354231 — DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC · Phase 2 · recruiting
- NCT05428631 — Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Ca · NA · 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 NCT04170309 (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 Advanz Pharma
- Last refreshed: 7 July 2023
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/NCT04170309.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing