NCT05856227 is a Phase 3 clinical trial of Ceftobiprole medocaril in Neonatal Sepsis, sponsored by Basilea Pharmaceutica.

Who is sponsoring NCT05856227?

NCT05856227 is sponsored by Basilea Pharmaceutica.

What drugs are being tested in NCT05856227?

Interventions in NCT05856227: Ceftobiprole medocaril.

What condition does NCT05856227 study?

NCT05856227 studies Neonatal Sepsis.

Is NCT05856227 still recruiting?

NCT05856227 is currently completed. Last updated 28 July 2025.

Are results published for NCT05856227?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-28 · How we verify

NCT05856227

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age

Completed Phase 3 Results posted Last updated 28 July 2025

What this trial tests

Phase 3 trial testing Ceftobiprole medocaril in Neonatal Sepsis in 9 participants. Completed in 18 December 2024.

Timeline

6 August 2023

Primary endpoint
18 December 2024

18 December 2024

Quick facts

Lead sponsor	Basilea Pharmaceutica
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	6 August 2023
Primary completion	18 December 2024
Estimated completion	18 December 2024
Sites	14 locations across Slovakia, Estonia, Germany, Poland, Lithuania, Bulgaria, United States, Latvia

Drugs / interventions tested

Ceftobiprole medocaril (Ceftobiprole medocaril) — full drug profile →

Conditions studied

Neonatal Sepsis — all drugs for Neonatal Sepsis →

Sponsor

Basilea Pharmaceutica — full company profile →

Who can join

Adults 3 Days to 3 Months, any sex, with Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Adverse Events (AEs) Primary · Up to 5-7 weeks

Number of patients with AEs, serious adverse events (SAEs), AEs leading to discontinuations and AEs of special interest

Any AE

Group	Value	95% CI
Pre-term Neonates	3
Term Neonates	3

Study-drug-related AE

Group	Value	95% CI
Pre-term Neonates	0
Term Neonates	0

SAE

Group	Value	95% CI
Pre-term Neonates	1
Term Neonates	1

Study-drug-related SAE

Group	Value	95% CI
Pre-term Neonates	0
Term Neonates	0

AE leading to treatment discontinuation

Group	Value	95% CI
Pre-term Neonates	0
Term Neonates	1

AE of special interest

Group	Value	95% CI
Pre-term Neonates	1
Term Neonates	1

Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite Secondary · On treatment Day 3 prior to and 2, 4, and 8 hours after the start of the first ceftobiprole infusion of the day

Observed pharmacokinetic parameter Cmax of ceftobiprole (the active moiety), its pro-drug ceftobiprole medocaril and the open-ring metabolite in term and pre-term neonates with post-natal age up to 3 months

Ceftobiprole

Group	Value	95% CI
Pre-term Neonates	17.2	11.0 – 22.6
Term Neonates	28.4	19.1 – 33.8

Ceftobiprole medocaril

Group	Value	95% CI
Pre-term Neonates	0.585	0.276 – 5.70
Term Neonates	0.552	0.376 – 2.59

Open-ring metabolite

Group	Value	95% CI
Pre-term Neonates	1.18	0.624 – 1.69
Term Neonates	1.68	0.998 – 2.06

Number of Patients With a Clinical Response Secondary · Up to 28 days

Clinical cure rate at the end of treatment (EOT) at day 3-14 and test of cure (TOC) at 7-14 days after last ceftobiprole dose visits in the Intent-to-Treat (ITT) population

EoT

Group	Value	95% CI
Pre-term Neonates	4
Term Neonates	2
Pre-term Neonates	0
Term Neonates	1
Pre-term Neonates	2
Term Neonates	0

TOC

Group	Value	95% CI
Pre-term Neonates	4
Term Neonates	2
Pre-term Neonates	0
Term Neonates	1
Pre-term Neonates	2
Term Neonates	0

Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS) Secondary · Up to 28 days

Improved signs and symptoms of LOS (including fever, hypothermia, abnormal heart rate, signs of impaired circulation, petechial rash or sclerema neonatorum, respiratory distress, gastrointestinal distress, irritability, lethargy and/or muscular or arterial hypotonia) assessed at Day 3, EOT, and TOC visits (ITT) populations.

Day 3

Group	Value	95% CI
Pre-term Neonates	1
Term Neonates	1
Pre-term Neonates	1
Term Neonates	0
Pre-term Neonates	3
Term Neonates	1
Pre-term Neonates	0
Term Neonates	1

EOT

Group	Value	95% CI
Pre-term Neonates	1
Term Neonates	1
Pre-term Neonates	1
Term Neonates	0
Pre-term Neonates	2
Term Neonates	1
Pre-term Neonates	1
Term Neonates	0

TOC

Group	Value	95% CI
Pre-term Neonates	2
Term Neonates	2
Pre-term Neonates	2
Term Neonates	0
Pre-term Neonates	1
Term Neonates	0
Pre-term Neonates	1
Term Neonates	1

Number of Patients With a Microbiological Response Secondary · Up to 28 days

Microbiological eradication or presumed eradication rate at the EOT and TOC visits.

EOT

Group	Value	95% CI
Pre-term Neonates	4
Term Neonates	1
Pre-term Neonates	0
Term Neonates	1
Pre-term Neonates	0
Term Neonates	1
Pre-term Neonates	2
Term Neonates	0

TOC

Group	Value	95% CI
Pre-term Neonates	4
Term Neonates	1
Pre-term Neonates	0
Term Neonates	1
Pre-term Neonates	0
Term Neonates	1
Pre-term Neonates	2
Term Neonates	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 5-7 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pre-term Neonates

Serious: 1/6 (17%)

Deaths: 0/6

Term Neonates

Serious: 1/3 (33%)

Deaths: 0/3

Serious adverse events (4 terms)

Reaction	System	Pre-term Neonates	Term Neonates
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Enterobacter sepsis	Infections and infestations	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Pre-term Neonates	Term Neonates
Oedema	General disorders	—	—
Thrombocytosis	Blood and lymphatic system disorders	—	—
Intraventricular haemorrhage neonatal	Nervous system disorders	—	—
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Adrenal haemorrhage	Endocrine disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Osteomyelitis	Infections and infestations	—	—
Sepsis neonatal	Infections and infestations	—	—
Vena cava thrombosis	Vascular disorders	—	—
Withdrawal syndrome	General disorders	—	—

Most-reported serious reactions: Thrombocytopenia, Respiratory failure, Intestinal obstruction, Enterobacter sepsis.

Data from ClinicalTrials.gov NCT05856227 adverse events section.

Sponsor's own description

This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ceftobiprole medocaril

Trials testing the same drug.

NCT04170309 — Collection of Data of Ceftobiprole Treated Patients: Comparison of Patients With and Without Certain Diseases · 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 Neonatal Sepsis

Currently open trials in the same condition.

NCT07421323 — Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection · NA · recruiting
NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting

Other Basilea Pharmaceutica trials

Trials by the same sponsor.

NCT06961708 — A Study of Fosmanogepix in Healthy Adult Chinese Subjects · Phase 1 · completed
NCT06808646 — A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin · Phase 1 · completed
NCT06733675 — Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination · Phase 1 · recruiting
NCT05421858 — A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invas · Phase 3 · recruiting
NCT06665555 — Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05856227 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Basilea Pharmaceutica
Last refreshed: 28 July 2025

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/NCT05856227.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing