Neonatal SepsisPhase 3NCT05856227
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
A Phase 3 study testing Ceftobiprole medocaril in people with Neonatal Sepsis, run by Basilea Pharmaceutica at 14 sites in 8 countries.
Trial summary
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'. Read more about this study
- Who is it for?
- Ages 3 days to 3 months
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Ceftobiprole medocaril
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 6 Aug 2023to 18 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent from parent(s) or other legally acceptable representative (LAR) to participate in the study
- Male or female, with a gestational age of ≥ 24 weeks and a post-natal age ranging from ≥ 3 days to ≤ 3 months
- Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment
- Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line
Who cannot join
- Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment
- Proven ventilator-associated pneumonia
- Proven central nervous system infection (e.g., meningitis, brain abscess)
- Proven osteomyelitis, infective endocarditis, or necrotizing enterocolitis
- Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, OR urinary output < 0.5 mL/kg/h (measured over at least 8 hours), OR requirement for dialysis
- Progressively fatal underlying disease, or life expectancy < 30 days
- Use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication
- Participation in another clinical study with an investigational product within 30 days of enrollment in the current study
Trial locations and contacts
14 sites in 8 countries.
14 sites in 8 countries
Bulgaria3 sites
MHAT Dr. Stamen Iliev AD Montana, Neonatology Department
Montana, 3400
UMHAT "Sveti Georgi" EAD, Pediatric surgery Clinic
Plovdiv, 4000
"Acibadem City Clinic University Hospital Tokuda" EAD, Neonatology Department
Sofia, 1407
United States2 sites
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
West Virginia University
Morgantown, West Virginia, 26506
Latvia2 sites
Pauls Stradins Clinical University Hospital
Riga, 1002
Children Clinical University Hospital - Neonatology Clinic
Riga, 1004
Lithuania2 sites
Lithuanian Health Science University Hospital Kauno klinikos - Neonatology Clinic
Kaunas, 50161
Vilnius University Hospital Santaros klinikos - Neonatology Center
Vilnius, 08410
Poland2 sites
Ginekologiczno-Położniczy Szpital Kliniczny im. Marcinkowskiego
Poznan, 60-535
Szpital Uniwersytecki - Klinika Neonatologii
Wroclaw, 50-556
Germany1 site
Klinikum der Universität München, Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital
Munich, Bavaria, 80337
About this study
Official title: A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis
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.
Read the detailed description
This was a multicenter, open-label, single-arm, multiple-dose study of intravenous (IV) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole). It could be combined with ampicillin and/or an aminoglycoside based on the Investigator's judgement according to manufacturer's instructions and/or local standard of care.
Following screening, ceftobiprole was administered as a 2-hour infusion at a dose of 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, depending on age and weight.
The target treatment duration was 3-10 days, which could be extended to 14 days if considered clinically necessary by the Investigator.
- Conditions
- Neonatal Sepsis
- Being tested
- Ceftobiprole medocaril
- Keywords
- Late-onset sepsis, Neonates, Infants
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftobiprole medocarilDrug
Ceftobiprole medocaril: 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, administered IV as a 2-hour infusion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm: Ceftobiprole | Experimental | Ceftobiprole medocaril: 7.5 mg/kg to 15 mg/kg Receives: Drug: Ceftobiprole medocaril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events (AEs)
Number of patients with AEs, serious adverse events (SAEs), AEs leading to discontinuations and AEs of special interest
Measured: Up to 5-7 weeks
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite
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
Measured: On treatment Day 3 prior to and 2, 4, and 8 hours after the start of the first ceftobiprole infusion of the day
Number of Patients With a Clinical Response
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
Measured: Up to 28 days
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
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.
Measured: Up to 28 days
Number of Patients With a Microbiological Response
Microbiological eradication or presumed eradication rate at the EOT and TOC visits.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start6 Aug 2023
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Engelhardt, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856227
- Sponsor's protocol ID
- BPR-PIP-003
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2023
- Last updated
- 28 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis
- ClinicalTrials.gov ID
- NCT05856227
- Acronym / sponsor ID
- BPR-PIP-003
- Conditions
- Neonatal Sepsis
- Keywords
- Late-onset sepsis, Neonates, Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Posted 28 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a multicenter, open-label, single-arm, multiple-dose study of intravenous (IV) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole). It could be combined with ampicillin and/or an aminoglycoside based on the Investigator's judgement according to manufacturer's instructions and/or local standard of care.
Following screening, ceftobiprole was administered as a 2-hour infusion at a dose of 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, depending on age and weight.
The target treatment duration was 3-10 days, which could be extended to 14 days if considered clinically necessary by the Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm: Ceftobiprole | Experimental | Drug: Ceftobiprole medocarilCeftobiprole medocaril: 7.5 mg/kg to 15 mg/kg |
Who may qualify
- Ages
- 3 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Informed consent from parent(s) or other legally acceptable representative (LAR) to participate in the study
- Male or female, with a gestational age of ≥ 24 weeks and a post-natal age ranging from ≥ 3 days to ≤ 3 months
- Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment
- Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line
Key exclusion criteria (8 listed)
- Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment
- Proven ventilator-associated pneumonia
- Proven central nervous system infection (e.g., meningitis, brain abscess)
- Proven osteomyelitis, infective endocarditis, or necrotizing enterocolitis
- Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, OR urinary output < 0.5 mL/kg/h (measured over at least 8 hours), OR requirement for dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftobiprole medocarilCeftobiprole medocaril: 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, administered IV as a 2-hour infusion. | Drug | Treatment Arm: Ceftobiprole |
Primary outcome
Number of Patients With Adverse Events (AEs)
Time frame: Up to 5-7 weeks
Number of patients with AEs, serious adverse events (SAEs), AEs leading to discontinuations and AEs of special interest
4 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite
Time frame: On treatment Day 3 prior to and 2, 4, and 8 hours after the start of the first ceftobiprole infusion of the day
Number of Patients With a Clinical Response
Time frame: Up to 28 days
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
Time frame: Up to 28 days
Number of Patients With a Microbiological Response
Time frame: Up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Engelhardt, MD study director
Basilea Pharmaceutica International Ltd, Allschwil
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceftobiprole medocaril in people with Neonatal Sepsis, run by Basilea Pharmaceutica at 14 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Bulgaria, United States, Latvia, Lithuania, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events (AEs) (time frame: Up to 5-7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.