Bacterial InfectionsPhase 1NCT02527681
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
A Phase 1 study testing Ceftobiprole medocaril in people with Bacterial Infections, run by Basilea Pharmaceutica at 14 sites in 6 countries.
Trial summary
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Bacterial Infections
- 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
- 15 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 22 Nov 2016to 25 Feb 2020
- Phase
- Phase 1
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates and infants ≤3 months, with gestational age ≥28 weeks
- Documented or presumed (or at risk of) bacterial infections, and currently receiving antibiotic treatment
- Expected to survive beyond the first 7 days after enrollment
- Sufficient vascular access to receive study drug, and to allow blood sampling at a site separate from the study drug infusion site
- Parent's / legally acceptable representative's informed consent to participate in the study
Who cannot join
- Major birth defect or malformation syndrome
- Proven presence of an immunodeficiency
- HIV or other congenital viral or fungal infection
- Significant laboratory abnormalities including: hematocrit <20%; absolute neutrophil count <0.5x10⁹/L; platelet count < 50x10⁹/L; alanine aminotransferase or aspartate aminotransferase >3 times the age-specific upper limit of normal
- Impaired renal function or known significant renal disease
- Any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
United States9 sites
Duke University Hospital
Durham, North Carolina, 27705
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Loma Linda University Medical Center
Loma Linda, California, 92354
University of Southern California
Los Angeles, California, 90089
University of California Los Angeles
Los Angeles, California, 90095
Norton Children's Hospital
Louisville, Kentucky, 40202
West Virginia University School of Medicine
Morgantown, West Virginia, 26506-9214
University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15224
Beacon Children's Hospital
South Bend, Indiana, 46601
About this study
Official title: An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
- Conditions
- Bacterial Infections
- Being tested
- Ceftobiprole medocaril
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftobiprole medocarilDrug
Also called ceftobiprole
Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril.
| Study group | Role | What they receive |
|---|---|---|
| Ceftobiprole | Experimental | Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for intravenous administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens. Receives: Drug: Ceftobiprole medocaril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximum observed plasma concentration (Cmax)
Measured: Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
Tmax
The time of maximum observed plasma concentration (Tmax)
Measured: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
AUC0-last
The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last)
Measured: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
T>MIC of 4 mg/L
The duration of time after dose for which free-drug concentrations remained above a value of 4 mg/L (T>MIC of 4 mg/L)
Measured: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start22 Nov 2016
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: on July 07, 2020 due to slow enrollment; there were no safety concerns.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527681
- Sponsor's protocol ID
- BPR-PIP-001
- Other IDs
- 2013-004614-18
- Status last verified
- May 2023
- First submitted
- 5 Aug 2015
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rubino CM, Polak M, Schropf S, Munch HG, Smits A, Cossey V, Tomasik T, Kwinta P, Snariene R, Liubsys A, Gardovska D, Hornik CD, Bosheva M, Ruehle C, Litherland K, Hamed K. Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients. Pediatr Infect Dis J. 2021 Nov 1;40(11):997-1003. doi: 10.1097/INF.0000000000003296.
PubMed 34533489
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics
- ClinicalTrials.gov ID
- NCT02527681
- Acronym / sponsor ID
- BPR-PIP-001
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: on July 07, 2020 due to slow enrollment; there were no safety concerns.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 6 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftobiprole | Experimental | Drug: Ceftobiprole medocarilCeftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for intravenous administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Neonates and infants ≤3 months, with gestational age ≥28 weeks
- Documented or presumed (or at risk of) bacterial infections, and currently receiving antibiotic treatment
- Expected to survive beyond the first 7 days after enrollment
- Sufficient vascular access to receive study drug, and to allow blood sampling at a site separate from the study drug infusion site
- Parent's / legally acceptable representative's informed consent to participate in the study
Key exclusion criteria (6 listed)
- Major birth defect or malformation syndrome
- Proven presence of an immunodeficiency
- HIV or other congenital viral or fungal infection
- Significant laboratory abnormalities including: hematocrit <20%; absolute neutrophil count <0.5x10⁹/L; platelet count < 50x10⁹/L; alanine aminotransferase or aspartate aminotransferase >3 times the age-specific upper limit of normal
- Impaired renal function or known significant renal disease
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 medocarilAlso: ceftobiproleCeftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril. | Drug | Ceftobiprole |
Primary outcome
Cmax
Time frame: Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
The maximum observed plasma concentration (Cmax)
Tmax
Time frame: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
The time of maximum observed plasma concentration (Tmax)
AUC0-last
Time frame: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last)
T>MIC of 4 mg/L
Time frame: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
The duration of time after dose for which free-drug concentrations remained above a value of 4 mg/L (T>MIC of 4 mg/L)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34533489Rubino CM, Polak M, Schropf S, Munch HG, Smits A, Cossey V, Tomasik T, Kwinta P, Snariene R, Liubsys A, Gardovska D, Hornik CD, Bosheva M, Ruehle C, Litherland K, Hamed K. Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients. Pediatr Infect Dis J. 2021 Nov 1;40(11):997-1003. doi: 10.1097/INF.0000000000003296.
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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
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftobiprole medocaril in people with Bacterial Infections, run by Basilea Pharmaceutica at 14 sites in 6 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Jun 2023. 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 United States, Belgium, Germany, Latvia, Lithuania and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 6 Jan 2021). 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?
Cmax (time frame: Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02527681, which also lists 1 linked publication.
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 5 Jun 2023.