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

NCT02527681 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-06-05

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Marc Engelhardt, MD · Basilea Pharmaceutica

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-22
Primary Completion
2020-02-25
Completion
2020-02-25
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Latvia
  • Lithuania
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527681 on ClinicalTrials.gov