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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the day 3 and up to 5-7 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the day 3 and up to 5-7 weeks
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 moreSecondary study objectives
All-cause mortality
Clinical response
Microbiological response
+2 moreSide effects data
From 2022 Phase 3 trial • 390 Patients • NCT0313873310%
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%
Extremity necrosis
1%
Leg amputation
1%
Cholestasis
1%
Arrhythmia
1%
Leukopenia
1%
Generalised tonic-clonic seizure
1%
Headache
1%
Hypoglycaemic seizure
1%
Pneumonia aspiration
1%
Respiratory failure
1%
Oesophageal varices haemorrhage
1%
Retroperitoneal haematoma
1%
Acute kidney injury
1%
Hydronephrosis
1%
Renal haematoma
1%
Renal impairment
1%
Cutaneous vasculitis
1%
COVID-19 pneumonia
1%
Candida sepsis
1%
Endocarditis staphylococcal
1%
Osteomyelitis
1%
Pneumonia staphylococcal
1%
Purulent pericarditis
1%
Pyelonephritis acute
1%
Skin bacterial infection
1%
Urosepsis
1%
Arteriovenous fistula thrombosis
1%
Kidney rupture
1%
Post procedural haemorrhage
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My septic shock hasn't improved after 60 minutes of treatment in the last 48 hours.I have been diagnosed with pneumonia caused by a ventilator.I have a confirmed infection in my brain or spinal cord.I have good veins for receiving medication and for blood tests.I have been diagnosed with a severe infection in my bone, heart, or intestines.My kidney function is below normal, I produce less urine than expected, or I need dialysis.My baby is between 3 days and 3 months old, born at or after 24 weeks of pregnancy.I am being treated with antibiotics for a suspected or confirmed bacterial infection.My doctor expects I have less than 30 days to live due to my illness.I have used antibiotics for more than 2 days in the week before starting the study medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm: Ceftobiprole
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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