3児の親さん薬剤師のブログ

とある薬剤師です。感染症治療を考える素材をちょこっと提供。noteもあります https://note.com/twin1980

A phase 3 randomized double-blind comparison of ceftobiprole medocaril versus ceftazidime plus linezolid for the treatment of hospital-acquired pneumonia.

2014年 CIDで報告された、Phase 3 を振り返り。

最近、Ceftobiproleが気になってました。

 

 

HAP VAP エンピリックにMRSAカバーは、必要性が少ない日々を送っていますので

今、旨味は少ないですね。てか、必要性が高まらないで欲しいです。

 

肺炎の試験は、確定診断の難しさ、原因微生物ばらつきの難しさなどなどあり

どの試験も、もやもや感があります。

 

P : HAP VAP

E :  ceftobiprole 500 mg every 8 hours

C : ceftazidime 2 g every 8 hours plus linezolid 600 mg every 12 hours

O : primary outcome ; clinical cure

49.9% vs 52.8% (intent-to-treat [ITT], 95% confidence interval [CI] for the difference, −10.0 to 4.1)

 

Abstract

Background. Ceftobiprole, the active moiety of ceftobiprole medocaril, is a novel broad-spectrum cephalosporin, with bactericidal activity against a wide range of gram-positive bacteria, including Staphylococcus aureus (including methicillin-resistant strains) and penicillin- and ceftriaxone-resistant pneumococci, and gram-negative bacteria, including Enterobacteriaceae and Pseudomonas aeruginosa.

Methods. This was a double-blind, randomized, multicenter study of 781 patients with hospital-acquired pneumonia (HAP), including 210 with ventilator-associated pneumonia (VAP). Treatment was intravenous ceftobiprole 500 mg every 8 hours, or ceftazidime 2 g every 8 hours plus linezolid 600 mg every 12 hours; primary outcome was clinical cure at the test-of-cure visit.

Results. Overall cure rates for ceftobiprole vs ceftazidime/linezolid were 49.9% vs 52.8% (intent-to-treat [ITT], 95% confidence interval [CI] for the difference, −10.0 to 4.1) and 69.3% vs 71.3% (clinically evaluable [CE], 95% CI, −10.0 to 6.1). Cure rates in HAP (excluding VAP) patients were 59.6% vs 58.8% (ITT, 95% CI, −7.3 to 8.8), and 77.8% vs 76.2% (CE, 95% CI, −6.9 to 10.0). Cure rates in VAP patients were 23.1% vs 36.8% (ITT, 95% CI, −26.0 to −1.5) and 37.7% vs 55.9% (CE, 95% CI, −36.4 to 0). Microbiological eradication rates in HAP (excluding VAP) patients were, respectively, 62.9% vs 67.5% (microbiologically evaluable [ME], 95% CI, −16.7 to 7.6), and in VAP patients 30.4% vs 50.0% (ME, 95% CI, −38.8 to −0.4). Treatment-related adverse events were comparable for ceftobiprole (24.9%) and ceftazidime/linezolid (25.4%).

Conclusions. Ceftobiprole is a safe and effective bactericidal antibiotic for the empiric treatment of HAP (excluding VAP). Further investigations are needed before recommending the use of ceftobiprole in VAP patients.

Clinical Trials Registration.NCT00210964, NCT00229008.

 

補足

 

 第61回日本感染症学会 東日本 シンポジウム22 より

http://www.societyinfo.jp/godo2012/abstracts/shitei/151-S22-1%2810055%29.pdf