Last updated on July 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bacterial Infections | Bacterial Infection
  • Age: - 1 Years
  • Gender: Male or Female

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 enrolment
  • 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: Haematocrit <20%; Absolute neutrophil count <0.5x10/L; Platelet count < 50x10/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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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