さまよう薬剤師のブログ

感染症治療を考える素材を提供します。最近は意思決定への応用が関心領域。双子と0歳の育児奮闘中。I have Ph.D. but less sense a ID pharmacist (ICPS). Another face is an investor.

Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis

NEJMに報告された、POET trial 。

デンマークにおける、IEに対する経口 vs 注射 RCT。

 

 

www.ncbi.nlm.nih.gov

 

感想

 

面白い!Supplementary読むことおすすめ。

これからは、switch、OPATが重要な時代になる。

switch推進派の私には、頼もしい報告。

 

我々の抄読会での主な討論

・感染性心内膜炎は右心系が多いはずであり,その意味でも右心系で既に結果が出ていることから今回の結果も当然の結果と言えそうである.

・Limitationsにもあるように,合併症の多い高齢者を除いており,チャンピオンデータを集めている.選択バイアスはそれなりに大きいと言わざるを得ない.

・この結果の通りにガイドラインが改訂されることがあれば,感染性心内膜炎の治療はかなり入院期間が減らせることになる.敗血症としてまずは2週間という先入観も捨てる必要がある.

・このStudyでは菌種を特定しており,耐性菌は除外しているが,血液培養で耐性菌が出た時には内服での抗生物質は非常に高価な薬剤になるので,今回の研究結果がどうであっても医療経済の面でも静脈投与継続が望まれそうだ.

 

note

 

 

f:id:akinohanayuki:20180831053744j:plain

 

f:id:akinohanayuki:20180831053752j:plain

 

Abstract


Background

Patients with infective endocarditis on the left side of the heart are typically treated with intravenous antibiotic agents for up to 6 weeks. Whether a shift from intravenous to oral antibiotics once the patient is in stable condition would result in efficacy and safety similar to those with continued intravenous treatment is unknown.

Methods

In a randomized, noninferiority, multicenter trial, we assigned 400 adults in stable condition who had endocarditis on the left side of the heart caused by streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci and who were being treated with intravenous antibiotics to continue intravenous treatment (199 patients) or to switch to oral antibiotic treatment (201 patients). In all patients, antibiotic treatment was administered intravenously for at least 10 days. If feasible, patients in the orally treated group were discharged to outpatient treatment. The primary outcome was a composite of all-cause mortality, unplanned cardiac surgery, embolic events, or relapse of bacteremia with the primary pathogen, from the time of randomization until 6 months after antibiotic treatment was completed.

Results

After randomization, antibiotic treatment was completed after a median of 19 days (interquartile range, 14 to 25) in the intravenously treated group and 17 days (interquartile range, 14 to 25) in the orally treated group (P=0.48). The primary composite outcome occurred in 24 patients (12.1%) in the intravenously treated group and in 18 (9.0%) in the orally treated group (between-group difference, 3.1 percentage points; 95% confidence interval, -3.4 to 9.6; P=0.40), which met noninferiority criteria.

Conclusions

In patients with endocarditis on the left side of the heart who were in stable condition, changing to oral antibiotic treatment was noninferior to continued intravenous antibiotic treatment. (Funded by the Danish Heart Foundation and others; POET ClinicalTrials.gov number, NCT01375257 .).

 

Supp

 

f:id:akinohanayuki:20180831054009p:plain

f:id:akinohanayuki:20180831054800p:plain