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.

Open-Label Randomized Trial of Early Clinical Outcomes of Ceftaroline Fosamil Versus Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections at Risk of Methicillin-Resistant Staphylococcus aureus

皮膚・軟部組織感染に対する

Ceftaroline vs VCM

RCT

 

primary outcome 

Early Clinical Response [ Time Frame: 48 to 72 hours after initiation of study drug ]

Reduction of lesion size from baseline of at least 20%

 

Ceftaroline

600 mg IV (over 1 hour) every 12 hours for renal function > 50 mL/min, adjusted for renal function based on package insert for no more than 14 days.
 
Vancomycin
Dosed by institutional pharmacy protocol to reach goal trough level of 10 - 20 mg/L steady state concentration for no more than 14 days.

 

link.springer.com

 

f:id:akinohanayuki:20190421070226j:plain

 

感想

 

非劣勢となったトライアル。

Ceftarolineは、緑膿菌スペクトルなく使いやすそうですが、

価格重要ですが、耐性化はどうなのでしょうか?推移を要チェックですね。

 

Abstract


Introduction

Acute bacterial skin and skin structure infections (ABSSSIs) remain among the most common infectious processes seen in the clinical setting. For patients with complicated ABSSSIs deemed to require intravenous antibiotics, vancomycin remains the mainstay therapy. Ceftaroline has been shown to be non-inferior to vancomycin and may result in faster resolution of signs of infection.

Methods

Multicenter, prospective, open-label, randomized trial of ceftaroline versus vancomycin for the treatment of adult patients admitted for management of ABSSSIs from April 2012 to May 2016; 166 patients in the clinically evaluable (CE) group were needed to determine a 20% difference in primary outcome of clinical response at day 2 or 3 of antibiotics. Clinical response was defined as cessation of spread of lesion and improvement in systemic signs/symptoms of infection. A secondary outcome was a ≥ 20% reduction in lesion size at day 2 or 3 of antibiotics.

Results

One hundred seventy-four patients were enrolled in the intention-to-treat (ITT) group and 108 were CE. Among CE patients, 54 were randomized to ceftaroline and 54 to vancomycin. Baseline characteristics were similar except patients in the ceftaroline arm were older and had a non-significantly higher degree of comorbidities (median Charlson score 2 vs. 4, respectively). Cellulitis was the most common type of ABSSSI (85.2% vs. 79.6%, respectively). Rapid diagnostic testing of available cultures (n = 55) demonstrated high agreement with clinical microbiology for identification of Staphylococcus aureus (100%) and MRSA (100%). There was no significant difference in primary outcome of day 2 or 3 clinical response (50.0% vs. 51.9%).

Conclusion

Early clinical response between vancomycin- and ceftaroline-treated ABSSSIs was similar. Patients with ABSSSIs rarely remained hospitalized for > 2–3 days, thus limiting our ability to critically assess clinical outcomes.

Trial Registration

ClinicalTrials.gov identifier, NCT02582203.

Funding

Allergan plc.

 

 

www.idstewardship.com

 

KEY POINTS

  • Ceftaroline (Teflaro) is a cephalosporin and beta-lacatam antibiotic that inhibits the growth of susceptible organisms by interfering with cell wall synthesis
  • The first commercially available beta-lactam in the United States with activity versus MRSA
    • Many people consider ceftaroline to have a spectrum similar to that of ceftriaxone, but with added anti-MRSA coverage
    • DOES NOT cover Pseudomonas aeruginosa
  • Has FDA-indications for skin and soft tissue infection as well as community acquired pneumonia
  • Requires dosage adjustment for renal function