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.

Omadacycline for Community-Acquired Bacterial Pneumonia

NEJMに報告された、OPTIC

市中肺炎に対するOmadacycline vs moxifloxacin P3 RCT。

3日後から内服スイッチ。

 

主要評価項目は,早期の臨床反応。生存しており、4つの症状(咳、痰、胸痛、呼吸困難)のうち少なくとも2つの改善。

非劣性マージンは 10パーセント。

https://www.nejm.org/doi/full/10.1056/NEJMoa1800201

 

f:id:akinohanayuki:20190209190702j:plain

 

感想

CAPに対して、Omadacyclineは、moxifloxacinと非劣勢でした。

Twelve deaths (8 in the omadacycline group and 4 in the moxifloxacin group)は、気になるので、慎重にウォッチですね。

 なお、Omadacyclineとは、テトラサイクリン系でESBLにもスペクトルあり。

テトラサイクリンなので、8歳以下は避けるべし。骨と歯への影響のため。

www.idstewardship.com

 

Abstract


BACKGROUND
Omadacycline, a new once-daily aminomethylcycline antibiotic agent that can be administered intravenously or orally, reaches high concentrations in pulmonary tissues and is active against common pathogens that cause community-acquired bacterial pneumonia.


METHODS
In a double-blind trial, we randomly assigned (in a 1:1 ratio) adults with community-acquired bacterial pneumonia (Pneumonia Severity Index risk class II, III, or IV) to receive omadacycline (100 mg intravenously every 12 hours for two doses, then 100 mg intravenously every 24 hours), or moxifloxacin (400 mg intravenously every 24 hours). A transition to oral omadacycline (300 mg every 24 hours) or moxifloxacin (400 mg every 24 hours), respectively, was allowed after 3 days; the total treatment duration was 7 to 14 days. The primary end point was early clinical response, defined as survival with improvement in at least two of four symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) and no worsening of symptoms at 72 to 120 hours, without receipt of rescue antibacterial therapy. A secondary end point was investigator-assessed clinical response at a post-treatment evaluation 5 to 10 days after the last dose, with clinical response defined as resolution or improvement in signs or symptoms to the extent that further antibacterial therapy was unnecessary. A noninferiority margin of 10 percentage points was used.


RESULTS
The intention-to-treat population included 386 patients in the omadacycline group and 388 patients in the moxifloxacin group. Omadacycline was noninferior to moxifloxacin for early clinical response (81.1% and 82.7%, respectively; difference, −1.6 percentage points; 95% confidence interval [CI], −7.1 to 3.8), and the rates of investigator-assessed clinical response at the post-treatment evaluation were 87.6% and 85.1%, respectively (difference, 2.5 percentage points; 95% CI, −2.4 to 7.4). Adverse events that emerged after treatment initiation were reported in 41.1% of the patients in the omadacycline group and 48.5% of the patients in the moxifloxacin group; the most frequent events were gastrointestinal (10.2% and 18.0%, respectively), and the largest difference was for diarrhea (1.0% and 8.0%). Twelve deaths (8 in the omadacycline group and 4 in the moxifloxacin group) occurred during the trial.


CONCLUSIONS
Omadacycline was noninferior to moxifloxacin for the treatment of community-acquired bacterial pneumonia in adults. (Funded by Paratek Pharmaceuticals; OPTIC ClinicalTrials.gov number, NCT02531438.)

 

 

感染症プラチナマニュアル 2019

感染症プラチナマニュアル 2019