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

Basilea Pharmaceutica

Status and phase: Terminated; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: Ceftobiprole medocaril

Study type: Interventional

Funder types: Industry

Identifiers

NCT02527681

2013-004614-18 (EudraCT Number)

BPR-PIP-001

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Ceftobiprole

Experimental group

Description:

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.

Treatment:

Drug: Ceftobiprole medocaril