Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials

• Published in: BMC infectious diseases Vol. 19; no. 1; pp. 195 - 12
• Main Authors: Scheeren, Thomas W L, Welte, Tobias, Saulay, Mikael, Engelhardt, Marc, Santerre-Henriksen, Anne, Hamed, Kamal
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 26-02-2019; BioMed Central; BMC
• Subjects: Aged; Aged, 80 and over; Analysis; Anti-Bacterial Agents - therapeutic use; Ceftaroline; Ceftazidime - therapeutic use; Ceftobiprole; Ceftriaxone - therapeutic use; Cephalosporin; Cephalosporins; Cephalosporins - therapeutic use; Chronic obstructive lung disease; Clinical trials; Community-Acquired Infections - drug therapy; Community-Acquired Infections - mortality; Community-acquired pneumonia; Comorbidity; Critically ill persons; Cross Infection - drug therapy; Cross Infection - mortality; Drug therapy; Female; Health aspects; Hospital-acquired pneumonia; Humans; Linezolid; Linezolid - therapeutic use; Male; Medical research; Methicillin; Middle Aged; Mortality; Pneumonia; Pneumonia - drug therapy; Pneumonia - mortality; Retrospective Studies; Risk factors; Severity of Illness Index; Treatment Outcome; Hospital-acquired pneumonia; Community-acquired pneumonia; Cephalosporin; Ceftobiprole
• ISSN: 1471-2334; 1471-2334
• DOI: 10.1186/s12879-019-3820-y

Patients with pneumonia who are elderly or severely ill are at a particularly high risk of mortality. This post hoc retrospective analysis of data from two Phase III studies evaluated early improvement outcomes in subgroups of high-risk patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP, excluding ventilator-associated pneumonia [VAP]).
One study included hospitalised CAP patients randomised to ceftobiprole or ceftriaxone ± linezolid treatment. The other study included HAP patients, who were randomised to ceftobiprole or ceftazidime plus linezolid treatment. The primary outcome was rate of early clinical response (Day 3 in CAP and Day 4 in HAP patients). Additional outcome measures included clinical cure at a test-of-cure visit, 30-day all-cause mortality and safety.
The overall high-risk group comprised 398 CAP patients and 307 HAP patients with risk factors present at baseline. The rate of early response was numerically higher in ceftobiprole-treated patients vs comparator-treated patients in the following high-risk groups: CAP patients aged ≥75 years (16.3% difference, 95% confidence interval [CI]: 1.8, 30.8); CAP patients with COPD (20.1% difference, 95% CI: 8.8, 31.1); all high-risk HAP patients (12.5% difference, 95% CI: 3.5, 21.4); HAP patients with >10 baseline comorbidities (15.3% difference, 95% CI: 0.3, 30.4).
Previous studies show that ceftobiprole is an efficacious therapy for patients with pneumonia who are at high risk of poor outcomes. This post hoc analysis provides preliminary evidence that ceftobiprole treatment may have advantages over other antibiotics in terms of achieving early improvement in high-risk patients with HAP (excluding VAP) and in some subgroups of high-risk CAP patients.
NCT00210964 : registered September 21, 2005; NCT00229008 : registered September 29, 2005; NCT00326287 : registered May 16, 2006.