さまよう薬剤師のブログ

学位を持っても、センスのない、感染制御専門薬剤師のブログ.  I have Ph.D. but less sense ID pharmacist.

Surotomycin versus vancomycin in adults with Clostridium difficile infection: primary clinical outcomes from the second pivotal, randomized, double-blind, Phase 3 trial

JAC に報告された、CIDに対するSurotomucin、P3

academic.oup.com

 

 

Abstract

Background

The available treatment options for Clostridium difficile infection (CDI) are limited by high recurrence rates. Surotomycin was a novel bactericidal cyclic lipopeptide in development to treat CDI that demonstrated non-inferiority to vancomycin in a Phase 2 trial.

Objectives

To assess surotomycin safety and clinical response (non-inferiority versus vancomycin) at the end of treatment (EOT) of CDI. Additionally, to assess surotomycin response over time and sustained response at 30–40 days post-EOT (superiority versus vancomycin).

Patients and methods

Patients with CDI were randomized (1:1) to receive twice-daily oral surotomycin 250 mg alternating with twice-daily placebo or four-times-daily oral vancomycin 125 mg for 10 days in this Phase 3, double-blind, multicentre, international trial. Clinical response over time and sustained clinical response were monitored until the end of the trial, through a follow-up period of 30–40 days. Clinical Trial Registration: NCT01598311.

Results

A total of 285 and 292 patients with confirmed CDI were randomized to receive surotomycin and vancomycin, respectively. Surotomycin-associated clinical response at EOT was non-inferior to vancomycin (surotomycin/vancomycin: 83.4%/82.1%; difference 1.4%, 95% CI − 4.9, 7.6). Following treatment with surotomycin, both clinical response over time (stratified log-rank test, P =0.277) and sustained clinical response (63.3%/59.0%; difference 4.3%, 95% CI − 3.6, 12.2) did not demonstrate superiority versus vancomycin at end of trial. Both treatments were generally well tolerated.

Conclusions

Surotomycin demonstrated non-inferiority to vancomycin for CDI clinical response at EOT. Surotomycin did not demonstrate superiority to vancomycin for clinical response over time or sustained clinical response rate.

 

PECO

 

P : Patients with CDI 

E :  twice-daily oral surotomycin 250 mg for 10 days

C : twice-daily placebo or four-times-daily oral vancomycin 125 mg for 10days

O : Surotomycin-associated clinical response at EOT was non-inferior to vancomycin (surotomycin/vancomycin: 83.4%/82.1%; difference 1.4%, 95% CI − 4.9, 7.6). 

sustained clinical response (63.3%/59.0%; difference 4.3%, 95% CI − 3.6, 12.2).

T : Phase 3, double-blind, multicentre, international trial, ITT

 

f:id:akinohanayuki:20171201060323p:plain

 

サンプルサイズ : 片群あたり258は超えているが、脱落数は多め

 

f:id:akinohanayuki:20171201060356p:plain

f:id:akinohanayuki:20171201060415p:plain

f:id:akinohanayuki:20171201060427p:plain

 

感想

 

微妙でした。

この結果では、私が患者であれば、VCMを希望します。

価格はVCMより安価でないでしょうし...