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

Bacterial Infections Clinical Trial

Official title:

An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02527681
• Other study ID #: BPR-PIP-001
• Secondary ID: 2013-004614-18
• Status: Terminated
• Phase: Phase 1
• Start date: November 22, 2016
• Est. completion date: February 25, 2020

Study information

• Verified date: May 2023
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

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 <0.5x10?/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

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Latvia,  Lithuania,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	The maximum observed plasma concentration (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.
Primary	Tmax	The time of maximum observed plasma concentration (Tmax)	Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
Primary	AUC0-last	The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (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.
Primary	T>MIC of 4 mg/L	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)	Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.