Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies.
Tobias WelteThomas Wl ScheerenJ Scott OvercashMikael SaulayMarc EngelhardtKamal A HamedPublished in: Future microbiology (2021)
Aim: To evaluate the efficacy and safety of ceftobiprole in patients aged ≥65 years. Materials & methods: We conducted a post hoc analysis of three randomized, double-blind, Phase III studies in patients with acute bacterial skin and skin structure infections, community-acquired pneumonia and hospital-acquired pneumonia. Results: Findings for patients aged ≥65 years (n = 633) were consistent with those for the overall study populations, although a trend toward improved outcomes was reported in some subgroups, for example, patients aged ≥75 years with community-acquired pneumonia were more likely to achieve an early clinical response with ceftobiprole than comparator (treatment difference 16.3% [95% CI:1.8-30.8]). The safety profile was similar between treatment groups in all studies. Conclusion: This analysis further supports the efficacy and safety of ceftobiprole in older patients with acute bacterial skin and skin structure infections or pneumonia. Clinicaltrials.gov trial identifiers: NCT03137173, NCT00326287, NCT00210964, NCT00229008.
Keyphrases
- phase iii
- end stage renal disease
- double blind
- clinical trial
- ejection fraction
- newly diagnosed
- chronic kidney disease
- open label
- placebo controlled
- community acquired pneumonia
- peritoneal dialysis
- prognostic factors
- type diabetes
- phase ii
- healthcare
- adipose tissue
- emergency department
- intensive care unit
- metabolic syndrome
- extracorporeal membrane oxygenation
- patient reported
- acute respiratory distress syndrome
- combination therapy
- weight loss
- wound healing
- replacement therapy