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 either hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring intravenous (IV) antibiotic therapy.
Who can participate
Age range3 Months – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<0.5x10⁹/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 react…
What they're measuring
1
Adverse Events
Timeframe: Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days