ISSUE 1543
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The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.
ABSSSIs — The FDA's definition of an ABSSSI includes cellulitis/erysipelas, major cutaneous abscess, wound infection, or burn infection, with a minimum lesion size of 75 cm2 and symptoms of systemic infection. Patients with chronic infections such as diabetic foot and decubitus ulcer infections, human and animal bites, and necrotizing fasciitis are excluded from ABSSSI trials.1
STANDARD TREATMENT — In many parts of the US, purulent skin and soft-tissue infections are now
... more- KM Itani and AF Shorr. FDA guidance for ABSSSI trials: implications for conducting and interpreting clinical trials. Clin Infect Dis 2014; 58 (Suppl 1):S4.
- DL Stevens et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis 2014; 59:147.
- Drugs for common bacterial infections in adults. Med Lett Drugs Ther 2017; 59:171.
- JC Cho et al. What is old is new again: delafloxacin, a modern fluoroquinolone. Pharmacotherapy 2018; 38:108.
- RK Flamm et al. In vitro activity of delafloxacin tested against isolates of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Antimicrob Agents Chemother 2016; 60:6381.
- JM Remy et al. Activity of delafloxacin against methicillin-resistant Staphylococcus aureus: resistance selection and characterization. J Antimicrob Chemother 2012; 67:2814.
- J Pullman et al. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a phase 3, double-blind, randomized study. J Antimicrob Chemother 2017; 72:3471.
- W O'Riordan et al. 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. Clin Infect Dis 2018; in press.
- S McCurdy et al. In vitro activity of delafloxacin and microbiological response against fluoroquinolone-susceptible and nonsusceptible Staphylococcus aureus isolates from two phase 3 studies of acute bacterial skin and skin structure infections. Antimicrob Agents Chemother 2017; 61:e00772-17.
- Alternatives to fluoroquinolones. Med Lett Drugs Ther 2016; 58:75.
- JS Litwin et al. A thorough QT study to evaluate the effects of therapeutic and supratherapeutic doses of delafloxacin on cardiac repolarization. Antimicrob Agents Chemother 2015; 59:3469.
- J Ferguson et al. Assessment of phototoxicity potential of delfloxacin in healthy male and female subjects: a phase 1 study. Poster presented at ICAAC/ICC, San Diego, CA, Sept 17-21, 2015. Poster F-1198a.
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