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

Purpose

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

Condition

  • Bacterial Infections

Eligibility

Eligible Ages
Under 3 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ceftobiprole 		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
    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.
    Other names:
    • ceftobiprole

More Details

Status
Terminated
Sponsor
Basilea Pharmaceutica

Study Contact