Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03439124
• Date of registration: 30/01/2018
• Prospective Registration: No
• Primary sponsor: Basilea Pharmaceutica
• Public title: Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
• Scientific title: A Multicentre, Randomized, Investigator-blind, Active-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Ceftobiprole Versus Intravenous Standard-of-care Cephalosporin Treatment With or Without Vancomycin in Pediatric Patients Aged From 3 Months to Less Than 18 Years With Hospital-acquired Pneumonia or Community-acquired Pneumonia Requiring Hospitalisation
• Date of first enrolment: November 27, 2017
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03439124
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Georgia, Hungary, Romania

Contacts

• Name: Marc Engelhardt, MD
• Affiliation: Basilea Pharmaceutica

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male of female aged 3 months to < 18 years with a body weight of at least 5 kg

- Diagnosis of either hospital-acquired pneumonia or community-acquired pneumonia
requiring hospitalization and administration of IV antibiotic therapy

- New or progressive imaging findings consistent with bacterial pneumonia

- Requirement for IV antibacterial treatment for pneumonia

- Other inclusion criteria may apply

Exclusion Criteria:

- Known resistance of the causative pathogen to ceftobiprole or IV standard-of-care
cephalosporin treatment (± vancomycin)

- On mechanical ventilation

- Chest trauma with severe lung contusion or flail chest

- Acute respiratory distress syndrome

- Empyema or lung abscess

- Anatomical bronchial obstruction

- Active or currently treated pulmonary tuberculosis

- Atypical bacterial pneumonia, or viral pneumonia without bacterial superinfection, or
need for antibiotic coverage with a macrolide

- Pertussis, chemical pneumonitis, or cystic fibrosis

- Severe immunodeficiency

- Significant laboratory abnormalities including: Hematocrit <20%; absolute neutrophil
count <0.5x10?/L; platelet count <50x10?/L; alanine aminotransferase, aspartate
aminotransferase, or bilirubin >5 times the age-specific upper limit of normal;

- Creatinine clearance <50 mL/min/1.73 m²

- Use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before
randomization

- History of a previous clinically-relevant hypersensitivity or serious adverse reaction
to beta lactam antibiotics or to vancomycin

- Poorly controlled seizure disorder

- Other exclusion criteria may apply



Age minimum: 3 Months
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hospital-acquired Pneumonia (HAP)

Community-acquired Pneumonia (CAP)

Intervention(s)

Drug: ceftobiprole medocaril

Drug: IV standard-of-care cephalosporin

Primary Outcome(s)

Adverse Events [Time Frame: Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days]

Secondary Outcome(s)

Proportion of Patients With Clinical Cure in the Intent-to-treat Population (ITT) [Time Frame: At the test-of-cure (TOC) visit]

Proportion of Patients With Early Clinical Response in the Clinically Evaluable (CE) Population [Time Frame: At Day 4]

Proportion of Patients With Clinical Cure in the Clinically Evaluable (CE) Population [Time Frame: At the TOC visit]

Proportion of Patients With Early Clinical Response in the Intent-to-treat (ITT) Population [Time Frame: At Day 4]

Secondary ID(s)

BPR-PIP-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03439124