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。https://note.mu/twin1980。

Decolonization to Reduce Postdischarge Infection Risk among MRSA Carriers

2月にNEJMで報告されたCLEAR trial。

MRSA 保菌者を対象に,退院後の衛生教育と,退院後の衛生教育+除菌を比較してます。

 

除菌は,クロルヘキシジンによる口腔洗浄,クロルヘキシジンを用いた入浴またはシャワー浴,ムピロシンの鼻腔内塗布を 5 日間,月 2 回,6 ヵ月間です。

 

https://www.nejm.org/doi/full/10.1056/NEJMoa1716771

clinicaltrials.gov

 

f:id:akinohanayuki:20190403131314j:plain

感想

 

パラダイムシフトにつながる素晴らしい研究。

ただし、クロルヘキシジンを用いた入浴またはシャワー浴のプロセスは、日本に文化がまだないので根ずくのか?

しかし、トライしないとこのままガラパゴスとなりそう。

 

ジャーナルクラブにおいての意見


・参加者は3か月おきの面会おきに25~50ドルの謝礼が出ているが,この謝礼は介護者には払われなかったのか.インセンティブのあり方でもバイアスが大きく関わる。
・クロルヘキシジンの浴槽とかシャワーは,日本では有効な濃度で実施されていないことが多い.
・糖尿病のP値が,比較群と対象群で0.08と低いが,これはどうしてか.選択バイアスは?
・ムピロシンはあまり使われていない抗菌薬という印象があるが.当院ではどういうときに出るのか.他院では,心臓外科の手術後などで使われることがある?
(小児では、バクトロバンとして使用されることが多いらしい)
・プライマリーアウトカムでCDCの基準を満たした感染とあるが,Limitationsでも老人ホームで基準が厳格に適用されなかったとあるが,なかなか判断が徹底できているのだろうか.
(CDCの感染基準に準拠して診断されていた)
・2次アウトカムにしてもMRSAの臨床症状の出現はなかなか難しい判断と言えそうだが.
・そうは言っても,MRSAに対してここまで真正面から研究を組むのはさすが感染症医学の先進国のアメリカだ.

 

Abstract

BACKGROUND

Hospitalized patients who are colonized with methicillin-resistant Staphylococcus aureus (MRSA) are at high risk for infection after discharge.

METHODS

We conducted a multicenter, randomized, controlled trial of postdischarge hygiene education, as compared with education plus decolonization, in patients colonized with MRSA (carriers). Decolonization involved chlorhexidine mouthwash, baths or showers with chlorhexidine, and nasal mupirocin for 5 days twice per month for 6 months. Participants were followed for 1 year. The primary outcome was MRSA infection as defined according to Centers for Disease Control and Prevention (CDC) criteria. Secondary outcomes included MRSA infection determined on the basis of clinical judgment, infection from any cause, and infection-related hospitalization. All analyses were performed with the use of proportional-hazards models in the per-protocol population (all participants who underwent randomization, met the inclusion criteria, and survived beyond the recruitment hospitalization) and as-treated population (participants stratified according to adherence).

RESULTS

In the per-protocol population, MRSA infection occurred in 98 of 1063 participants (9.2%) in the education group and in 67 of 1058 (6.3%) in the decolonization group; 84.8% of the MRSA infections led to hospitalization. Infection from any cause occurred in 23.7% of the participants in the education group and 19.6% of those in the decolonization group; 85.8% of the infections led to hospitalization. The hazard of MRSA infection was significantly lower in the decolonization group than in the education group (hazard ratio, 0.70; 95% confidence interval [CI], 0.52 to 0.96; P=0.03; number needed to treat to prevent one infection, 30; 95% CI, 18 to 230); this lower hazard led to a lower risk of hospitalization due to MRSA infection (hazard ratio, 0.71; 95% CI, 0.51 to 0.99). The decolonization group had lower likelihoods of clinically judged infection from any cause (hazard ratio, 0.83; 95% CI, 0.70 to 0.99) and infection-related hospitalization (hazard ratio, 0.76; 95% CI, 0.62 to 0.93); treatment effects for secondary outcomes should be interpreted with caution owing to a lack of prespecified adjustment for multiple comparisons. In as-treated analyses, participants in the decolonization group who adhered fully to the regimen had 44% fewer MRSA infections than the education group (hazard ratio, 0.56; 95% CI, 0.36 to 0.86) and had 40% fewer infections from any cause (hazard ratio, 0.60; 95% CI, 0.46 to 0.78). Side effects (all mild) occurred in 4.2% of the participants.

CONCLUSIONS

Postdischarge MRSA decolonization with chlorhexidine and mupirocin led to a 30% lower risk of MRSA infection than education alone. (Funded by the AHRQ Healthcare-Associated Infections Program and others; ClinicalTrials.gov number, NCT01209234.)

 

 

J-IDEO (ジェイ・イデオ) Vol.3 No.2

J-IDEO (ジェイ・イデオ) Vol.3 No.2