Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
Condition: Community-acquired Pneumonia (CAP); Hospital-acquired Pneumonia (HAP)
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia
Intervention: ceftobiprole medocaril; IV standard-of-care cephalosporin
Intervention description: Ceftobiprole medocaril was administered at age-adjusted doses (10, 15 or 20 mg/kg) and infusion durations (2 or 4 hours) every 8 hours. The maximum dose, regardless of body weight, was 500 mg ceftobiprole every 8 hours (maximum total daily dose of 1500 mg ceftobiprole).
After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.; Ceftriaxone was administered at 50 to 80 mg/kg IV as a single daily dose, up to a maximum dose of 2 g/day. The actual dose of ceftriaxone within this dose range was determined by the blinded investigator prior to first study drug administration and was not modified during subsequent study days.
After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.
At the discretion of the blinded investigator, patients received vancomycin at a dose of 10 to 15 mg/kg IV every 6 hours, up to a maximum dose of 2 g/day, in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed.
Intervention MeSH terms: Cephalosporins; Ceftobiprole; Ceftobiprole medocaril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 3 Months
Maximum age: 17 Years
Healthy volunteers: No

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 either hospital-acquired bacterial pneumonia (HAP) or
      community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring
      intravenous (IV) antibiotic therapy.
    

Eligibility 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 <0.5x10⁹/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