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

Stopped early · Phase 1

Conditions studied: Bacterial Infections

In brief

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

Key facts

Study ID

NCT02527681

Run by

Basilea Pharmaceutica

People needed

15

Starts

2016-11-22

Expected to finish

2020-02-25

Last updated by the study team

2023-06-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Beacon Children's Hospital — South Bend, Indiana, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• Duke University Hospital — Durham, North Carolina, United States
• University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• West Virginia University School of Medicine — Morgantown, West Virginia, United States
• UZ Leuven — Leuven, Belgium
• Klinikum der Universität München — Munich, Germany
• Children Clinical University Hospital — Riga, Latvia
• Vilnius University Children's Hospital — Vilnius, Lithuania
• University Children's Hospital of Kraków — Krakow, Poland

Full record on ClinicalTrials.gov

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