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

Phase 1

Terminated

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ceftobiprole	Ceftobiprole medocaril	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.

Primary Outcome Measures

Name	Time	Method
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.	The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last)
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.	The maximum observed plasma concentration (Cmax)
Tmax	Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.	The time of maximum observed plasma concentration (Tmax)
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.	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)

Secondary Outcome Measures

Name	Time	Method

Locations (14): Vilnius University Children's Hospital
🇱🇹
Vilnius, Lithuania
Children Clinical University Hospital
🇱🇻
Riga, Latvia
Loma Linda University Medical Center
🇺🇸
Loma Linda, California, United States
University of California Los Angeles
🇺🇸
Los Angeles, California, United States
Duke University Hospital
🇺🇸
Durham, North Carolina, United States
University Children's Hospital of Kraków
🇵🇱
Kraków, Poland
University of Southern California
🇺🇸
Los Angeles, California, United States
Beacon Children's Hospital
🇺🇸
South Bend, Indiana, United States
University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Klinikum der Universität München
🇩🇪
Munich, Germany
The University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
Norton Children's Hospital
🇺🇸
Louisville, Kentucky, United States
UZ Leuven
🇧🇪
Leuven, Belgium
West Virginia University School of Medicine
🇺🇸
Morgantown, West Virginia, United States