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Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.