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Cephalosporin Antibiotic

Ceftobiprole for Neonatal Sepsis

Phase 3
Recruiting
Research Sponsored by Basilea Pharmaceutica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the day 3 and up to 5-7 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study the safety and effectiveness of an antibiotic called ceftobiprole for newborns and infants with sepsis.

Who is the study for?
This trial is for term and pre-term newborns up to 3 months old with late-onset sepsis. Babies must have good vascular access, not be on certain other treatments or have specific infections like meningitis, severe kidney issues, a life expectancy under 30 days, or unresponsive septic shock.
What is being tested?
The study tests Ceftobiprole medocaril's safety and effectiveness in treating neonatal sepsis. It's an antibiotic approved for pneumonia in children and adults elsewhere but now being studied for infants with suspected bacterial infections.
What are the potential side effects?
As Ceftobiprole is an antibiotic from the cephalosporin family, potential side effects may include allergic reactions, gastrointestinal upset (like diarrhea), blood abnormalities, liver enzyme changes, and possible interactions with other drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the day 3 and up to 5-7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the day 3 and up to 5-7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with clinically relevant findings in laboratory tests
Number of participants with clinically relevant findings in physical examination
Number of participants with clinically relevant findings in vital signs
+1 more
Secondary study objectives
All-cause mortality
Clinical response
Microbiological response
+2 more

Side effects data

From 2022 Phase 3 trial • 390 Patients • NCT03138733
10%
Nausea
10%
Anaemia
9%
Blood potassium decreased
8%
Vomiting
7%
Diarrhoea
6%
Gamma-glutamyltransferase increased
2%
Pneumonia
2%
Septic shock
2%
Multiple organ dysfunction syndrome
1%
Retroperitoneal haematoma
1%
COVID-19 pneumonia
1%
Pneumonia aspiration
1%
Skin bacterial infection
1%
Oesophageal varices haemorrhage
1%
Osteomyelitis
1%
Pyelonephritis acute
1%
Pneumonia staphylococcal
1%
Headache
1%
Respiratory failure
1%
Cutaneous vasculitis
1%
Leg amputation
1%
Renal impairment
1%
Hydronephrosis
1%
Kidney rupture
1%
Hypoglycaemic seizure
1%
Endocarditis staphylococcal
1%
Renal haematoma
1%
Candida sepsis
1%
Purulent pericarditis
1%
Acute kidney injury
1%
Post procedural haemorrhage
1%
Extremity necrosis
1%
Cholestasis
1%
Arrhythmia
1%
Leukopenia
1%
Generalised tonic-clonic seizure
1%
Urosepsis
1%
Arteriovenous fistula thrombosis
1%
Atrial thrombosis
1%
Cardiac arrest
1%
Cardiac failure acute
1%
Cardiopulmonary failure
1%
Myocardial infarction
1%
Intra-abdominal haemorrhage
1%
Shock haemorrhagic
1%
Death
1%
Wound healing normal
1%
Acute myocardial infarction
1%
Seizure
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Bacteraemia
1%
Gangrene
1%
Infectious pleural effusion
1%
Lung abscess
1%
Mediastinitis
1%
Sepsis
1%
Haemodialysis complication
1%
Chloroma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ceftobiprole
Daptomycin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment Arm: CeftobiproleExperimental Treatment1 Intervention
Ceftobiprole medocaril: 7.5 mg/kg to 15 mg/kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftobiprole medocaril
2004
Completed Phase 3
~2240

Find a Location

Who is running the clinical trial?

Basilea PharmaceuticaLead Sponsor
51 Previous Clinical Trials
9,898 Total Patients Enrolled
Marc Engelhardt, MDStudy DirectorBasilea Pharmaceutica International Ltd, Allschwil
7 Previous Clinical Trials
1,562 Total Patients Enrolled

Media Library

Ceftobiprole medocaril (Cephalosporin Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05856227 — Phase 3
Neonatal Sepsis Research Study Groups: Treatment Arm: Ceftobiprole
Neonatal Sepsis Clinical Trial 2023: Ceftobiprole medocaril Highlights & Side Effects. Trial Name: NCT05856227 — Phase 3
Ceftobiprole medocaril (Cephalosporin Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05856227 — Phase 3
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