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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

Study 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.Check my eligibility

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.See study design

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

All-cause mortality

Clinical response

Microbiological response

+2 more

Side effects data

From 2022 Phase 3 trial • 390 Patients • NCT03138733

10%

Nausea

10%

Anaemia

Blood potassium decreased

Vomiting

Diarrhoea

Gamma-glutamyltransferase increased

Septic shock

Pneumonia

Multiple organ dysfunction syndrome

Cholestasis

Oesophageal varices haemorrhage

Renal impairment

Endocarditis staphylococcal

Osteomyelitis

Pneumonia staphylococcal

COVID-19 pneumonia

Pyelonephritis acute

Arteriovenous fistula thrombosis

Respiratory failure

Leg amputation

Headache

Hypoglycaemic seizure

Renal haematoma

Urosepsis

Extremity necrosis

Kidney rupture

Arrhythmia

Hydronephrosis

Retroperitoneal haematoma

Acute kidney injury

Cutaneous vasculitis

Purulent pericarditis

Pneumonia aspiration

Candida sepsis

Skin bacterial infection

Post procedural haemorrhage

Leukopenia

Generalised tonic-clonic seizure

Atrial thrombosis

Cardiac arrest

Cardiac failure acute

Cardiopulmonary failure

Myocardial infarction

Intra-abdominal haemorrhage

Shock haemorrhagic

Death

Wound healing normal

Acute myocardial infarction

Seizure

Acute respiratory distress syndrome

Acute respiratory failure

Bacteraemia

Gangrene

Infectious pleural effusion

Lung abscess

Mediastinitis

Sepsis

Haemodialysis complication

Chloroma

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Basilea PharmaceuticaLead Sponsor

41 Previous Clinical Trials

9,510 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals being considered for this experiment?

"As established by the trial's inclusion criteria, patients participating must be between 3 days and 3 months old."

Answered by AI

How many participants are included in the current iteration of this experiment?

"This medical study necessitates 15 suitable candidates who are able to attend either NorthShore University HealthSystem-Evanston Hospital in Evanston, Illinois or West virginia University in Morgantown, West Virginia."

Answered by AI

Has the United States Food and Drug Administration sanctioned Ceftobiprole as a therapeutic treatment?

"Our experts at Power rate the safety of Ceftobiprole with a 3, as this Phase 3 trial has yielded positive results in terms of efficacy and multiple data sets suggest its security."

Answered by AI

How many clinical practices are participating in this investigation?

"Fifteen clinical sites are available to collaborate on this trial. Among them are NorthShore University HealthSystem-Evanston Hospital in Evanston, West virginia University in Morgantown, and MHAT Dr. Stamen Iliev AD Montana, Neonatology Department in Montana."

Answered by AI

What is the eligibility criteria for participants in this trial?

"The criteria for eligibility in this medical trial requires a diagnosis of neonatal sepsis and an age between three days to three months old. Approximately 15 patients are being sought after by the research team."

Answered by AI

Are there any opportunities for participation in this investigation currently?

"Affirmative. Data from clinicaltrials.gov reveals that the trial, initially posted on May 1st 2023, is actively seeking out participants. 15 patients need to be recruited across 15 sites for this medical study."

Answered by AI

What is the desired outcome of this research endeavor?

"This clinical trial, which is intended to run for 5-7 weeks, will measure the efficacy of its intervention through the number of participants who experience clinically significant changes in laboratory results. Secondary objectives include assessing the clinical response rate at various time points, recording all-cause mortality rates amongst participants and measuring microbial eradication or presumed eradication rates post treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856227.

All > Sepsis