Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics

Study Overview
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Brief Summary
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This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.

Official Title
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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

Conditions
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Bacterial Infections

Intervention / Treatment
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* Drug: Ceftobiprole medocaril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftobiprole<br>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. | Drug: Ceftobiprole medocaril<br>* 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.<br>* Other names: ceftobiprole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | The maximum observed plasma concentration (Cmax) | 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) | 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) | 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) | Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |