A post hoc analysis of two Phase III trials showing the efficacy and tolerability of ceftobiprole in East Asian patients.
Haihui HuangLei GaoMarc EngelhardtMikael SaulayKamal A HamedPublished in: Future microbiology (2021)
Aim: To evaluate the efficacy and safety of ceftobiprole in patients from East Asia. Materials & methods: A post hoc analysis was conducted of two randomized, double-blind, Phase III studies in patients with community- or hospital-acquired pneumonia. Results: Findings for East Asian patients were consistent with the overall study populations. A trend toward higher microbiological eradication rates and numerically lower rates of all-cause mortality were reported for ceftobiprole versus comparators (all-cause mortality [intent-to-treat]: community-acquired pneumonia, 1.5 vs 2.8%; hospital-acquired pneumonia excluding ventilator-associated pneumonia, 5.9 vs 11.4%). The incidence of adverse events was similar between treatment groups. Conclusion: This post hoc analysis supports the efficacy and tolerability of ceftobiprole in East Asian patients. ClinicalTrials.gov trial identifiers: NCT00326287, NCT00210964, NCT00229008.
Keyphrases
- phase iii
- double blind
- end stage renal disease
- open label
- placebo controlled
- clinical trial
- chronic kidney disease
- newly diagnosed
- ejection fraction
- healthcare
- phase ii
- randomized controlled trial
- patient reported outcomes
- helicobacter pylori
- intensive care unit
- community acquired pneumonia
- study protocol
- mental health
- helicobacter pylori infection
- genetic diversity