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。

A Comparison of the Efficacy and Safety of Intravenous Followed by Oral Delafloxacin With Vancomycin Plus Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Multinational, Double-Blind, Randomized Study

CIDに報告された、急性細菌性皮膚・皮膚組織感染症(ABSSSI)に対する、P3。

  • delafloxacin 300 mg IV every 12 hours for 3 days with a switch to 450 mg oral delafloxacin
  • vancomycin 15 mg/kg IV with aztreonam for 5–14 days

 

academic.oup.com

 

感想

非劣勢。

消化器系副作用は、delafloxacin群に多いかも。

耐性菌出現どうなるか注視したい。

武器が増えたことは嬉しい。

 

note

delafloxacinは、MRSAに対してもスペクトルを有するキノロン系。

 

Abstract


Background
Delafloxacin is an intravenous (IV)/oral anionic fluoroquinolone with activity against gram-positive (including methicillin-resistant Staphylococcus aureus [MRSA]), gram-negative, atypical, and anaerobic organisms. It is approved in the United States for acute bacterial skin and skin structure infections (ABSSSIs) caused by designated susceptible gram-positive and gram-negative organisms, and is in development for the treatment of community-acquired bacterial pneumonia.
Methods
A multicenter, randomized, double-blind trial of 850 adults with ABSSSI compared delafloxacin 300 mg IV every 12 hours for 3 days with a switch to 450 mg oral delafloxacin, to vancomycin 15 mg/kg IV with aztreonam for 5–14 days. The primary endpoint was objective response at 48–72 hours. Investigator-assessed response based on resolution of signs and symptoms at follow-up (day 14 ± 1), and late follow-up (day 21–28) were secondary endpoints.
Results
In the intent-to-treat analysis set, the objective response was 83.7% in the delafloxacin arm and 80.6% in the comparator arm. Investigator-assessed success was similar at follow-up (87.2% vs 84.4%) and late follow-up (83.5% vs 82.2%). Delafloxacin was comparable to vancomycin + aztreonam in eradication of MRSA at 96.0% vs 97.0% at follow-up. Frequency of treatment-emergent adverse events between the groups was similar. Treatment-emergent adverse events leading to study drug discontinuation was higher in the vancomycin + aztreonam group (1.2% vs 2.4%).
Conclusions
In ABSSSI patients, IV/oral delafloxacin monotherapy was noninferior to IV vancomycin + aztreonam combination therapy for both the objective response and the investigator-assessed response at follow-up and late follow-up. Delafloxacin was well tolerated as monotherapy in treatment of ABSSSIs.
Clinical Trials Registration
NCT01984684. 

 

参照

 

2017. 65. 149. 化学療法学会より、

開発状況 

f:id:akinohanayuki:20180827080753p:plain

f:id:akinohanayuki:20180827080809p:plain

akinohanayuki.hatenablog.com