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

Primary Purpose

Bacterial Infections

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ceftobiprole medocaril
Sponsored by
Basilea Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Loma Linda University Medical Center
  • University of Southern California
  • University of California Los Angeles
  • Beacon Children's Hospital
  • Norton Children's Hospital
  • Duke University Hospital
  • University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital
  • The University of Texas Health Science Center at Houston
  • West Virginia University School of Medicine
  • UZ Leuven
  • Klinikum der Universität München
  • Children Clinical University Hospital
  • Vilnius University Children's Hospital
  • University Children's Hospital of Kraków

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ceftobiprole

Arm 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.

Outcomes

Primary Outcome Measures

Cmax
The maximum observed plasma concentration (Cmax)
Tmax
The time of maximum observed plasma concentration (Tmax)
AUC0-last
The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last)
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)

Secondary Outcome Measures

Full Information

First Posted
August 5, 2015
Last Updated
May 9, 2023
Sponsor
Basilea Pharmaceutica
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1. Study Identification

Unique Protocol Identification Number
NCT02527681
Brief Title
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
on July 07, 2020 due to slow enrollment; there were no safety concerns.
Study Start Date
November 22, 2016 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basilea Pharmaceutica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftobiprole
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ceftobiprole medocaril
Other Intervention Name(s)
ceftobiprole
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cmax
Description
The maximum observed plasma concentration (Cmax)
Time Frame
Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
Title
Tmax
Description
The time of maximum observed plasma concentration (Tmax)
Time Frame
Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
Title
AUC0-last
Description
The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last)
Time Frame
Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
Title
T>MIC of 4 mg/L
Description
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)
Time Frame
Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Engelhardt, MD
Organizational Affiliation
Basilea Pharmaceutica
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Beacon Children's Hospital
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
West Virginia University School of Medicine
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9214
Country
United States
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Klinikum der Universität München
City
Munich
Country
Germany
Facility Name
Children Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
Vilnius University Children's Hospital
City
Vilnius
Country
Lithuania
Facility Name
University Children's Hospital of Kraków
City
Kraków
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34533489
Citation
Rubino CM, Polak M, Schropf S, Munch HG, Smits A, Cossey V, Tomasik T, Kwinta P, Snariene R, Liubsys A, Gardovska D, Hornik CD, Bosheva M, Ruehle C, Litherland K, Hamed K. Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients. Pediatr Infect Dis J. 2021 Nov 1;40(11):997-1003. doi: 10.1097/INF.0000000000003296.
Results Reference
derived

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

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