Status:
COMPLETED
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Community-acquired Pneumonia (CAP)
Hospital-acquired Pneumonia (HAP)
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief Summary
This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with eith...
Detailed Description
This was a randomized, investigator-blind, active-controlled multi-center study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ceftobiprole medocaril compared with IV standard-...
Eligibility Criteria
Inclusion
- 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
- 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 \<0.5x10⁹/L; platelet count \<50x10⁹/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
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2020
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT03439124
Start Date
November 27 2017
End Date
March 16 2020
Last Update
May 12 2023
Active Locations (19)
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1
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
Pleven, Bulgaria, 5800
2
University Multiprofile Hospital for Active Treatment "Sveti Georgi"
Plovdiv, Bulgaria, 4002
3
Multiprofile Hospital for Active Treatment
Rousse, Bulgaria, 7002
4
University Multiprofile Hospital for Active Treatment "Aleksandrovska"
Sofia, Bulgaria, 1431