Decolonization of intestinal carriage of extended-spectrum β-lactamase-producing Enterobacteriaceae with oral colistin and neomycin: a randomized, double-blind, placebo-controlled trial.
Decolonization of intestinal carriage of extended-spectrum β-lactamase-producing Enterobacteriaceae with oral colistin and neomycin: a randomized, double-blind, placebo-controlled trial.
2013年JACに報告された、スイス単施設における、ESBL産生腸内細菌キャリア除菌を目的とした、経口コリスチン+ネオマイシンとプラセボの比較試験。
PECO
P : adult patients with an ESBL-E-positive rectal swab
E : colistin sulphate (50 mg 4×/day) and neomycin sulphate (250 mg 4×/day) for 10 days plus nitrofurantoin (100 mg 3×/day) for 5 days in the presence of ESBL-E bacteriuria
C : placebo
O :
The primary outcome was detection of ESBL-E by rectal swab 28 ± 7 days after the end of treatment. [14/27 (52%) versus 10/27 (37%), P = 0.27].
During treatment and shortly afterwards, there was significantly lower rectal ESBL-E carriage in the treatment group: 9/26 versus 19/22 on day 6 of treatment (P < 0.001) and 8/25 versus 20/26 on day 1 post-treatment (P = 0.001).
This effect had disappeared by day 7 post-treatment (18/27 versus 17/25, P = 0.92).
Liquid stools were more common in the treatment group (7/27 versus 2/29, P = 0.05).
T : double-blind, randomized, placebo-controlled, single-centre tria
Fig and Tab
感想
単施設RCTですが、主評価はネガティブ結果。
副評価には、有意な項目もあるが、現時点ではむずがしいですね。