Hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalisation. MedDRA version: 19.0 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862 MedDRA version: 19.0 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Zevtera©
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Ceftobiprole medocaril sodium
Current Sponsor code: BAL5788-001
Other descriptive name
Sponsors
Basilea Pharmaceutica International Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following at Screening: 1. Male or female aged 3 months to 38.5 °C) or hypothermia (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any one of the following at Screening: 1. Known resistance of the causative pathogen to ceftobiprole or IV standard-of-care cephalosporin treatment (± vancomycin) 2. On mechanical ventilation at Screening for more than 48 hours 3. Chest trauma with severe lung contusion or flail chest 4. Acute respiratory distress syndrome 5. Empyema or lung abscess 6. Anatomical bronchial obstruction 7. Documented or suspected active or currently-treated pulmonary tuberculosis 8. Documented or suspected atypical bacterial pneumonia, or viral pneumonia without bacterial superinfection, or need for antibiotic coverage with a macrolide 9. Positive result from a rapid diagnostic test for influenza or respiratory syncytial virus, unless bacterial pneumonia secondary to viral respiratory illness is suspected based on a clinical history of exacerbation of fever and respiratory symptoms after initial improvement in the symptoms of an acute respiratory infection 10. Documented or suspected pertussis, chemical pneumonitis (e.g., aspiration of gastric contents, inhalation injury), or cystic fibrosis 11. Severe immunodeficiency (HIV infection, or congenital or acquired immunodeficiency syndrome) 12. Significant laboratory abnormalities (based on local laboratory results) including: ? Hematocrit 5 × the age-specific upper limit of normal ? Creatinine clearance of < 50 mL/min/1.73 m2, or requirement for any form of renal dialysis therapy 13. Use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before randomization for the current episode of pneumonia 14. History of a previous clinically-relevant hypersensitivity or serious adverse reaction to beta-lactam antibiotics or to vancomycin 15. Poorly-controlled seizure disorder (? 1 seizure in the month preceding randomization)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterise the safety profile of ceftobiprole in paediatric patients with HAP or CAP requiring hospitalisation and intravenous (IV) antibiotic therapy;Secondary Objective: In paediatric patients with HAP or CAP requiring hospitalisation: ? - To compare the clinical cure rate and microbiological eradication rate at the test-of-cure (TOC) visit between ceftobiprole and IV standard-of-care cephalosporin treatment (± vancomycin) ? - To compare the clinical and microbiological relapse rates at the last follow-up (LFU) visit between ceftobiprole and IV standard-of-care cephalosporin treatment (± vancomycin) ?- To characterise other efficacy measures of ceftobiprole (e.g., improvement in signs and symptoms of pneumonia, length of hospital stay) ? - To assess the pharmacokinetics (PK) of ceftobiprole;Primary end point(s): Analysis of adverse events (AEs) assessed on each of the first 3 days of study-drug treatment, and at the end-of-treatment (EOT), TOC, and LFU visits (Safety population). ;Timepoint(s) of evaluation of this end point: Days 1, 2, 3, end of treatment (EOT), 7-14 days after EOT, 28-35 days after EOT (other timepoints may also be analyzed) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Efficacy: Comparison of clinical cure rates (ITT and CE populations) and microbiological eradication rates (mITT and ME populations) between ceftobiprole and the comparator at the TOC visit; and cure of pneumonia, defined as clinical improvement or lack of progression of X-ray abnormalities, as well as resolution of clinical pneumonia findings, at study Day 4 and the EOT visit (ITT and CE populations). The clinical and microbiological relapse rates at the LFU visit will also be compared (ITT, CE, mITT and ME populations). 2. Pharmacokinetics: Descriptive analysis of ceftobiprole plasma concentration per time point, based on PK sampling in at least 15 patients in each of the two age categories of < 6 years and = 6 years (PK population);Timepoint(s) of evaluation of this end point: Efficacy: Day 4, EOT, 7-14 days after EOT, 28-35 days after EOT; Pharmacokinetics: On Day 3 at the following time points: Children aged 2 years and older: pre-dose, and at 2h (end of infusion), 4h, 6h, and 8h after start of infusion Children aged less than 2 years: pre-dose and at 4h (end of infusion), 6h, and 8h after start of infusion | — |
Countries
Bulgaria, Hungary, Romania
Contacts
Public ContactNatalia Peppi
PSI CRO AG
Outcome results
None listed