Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 450 mg); Injection (intravenous; 300 mg) |
| Drug Class | Fluoroquinolone antibacterials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
- Indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.
Summary
- Delafloxacin (Baxdela) is an antibiotic medication used for treating adults with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). It has been evaluated through randomized controlled trials, comparing its efficacy and safety against other antibiotics.
- The information about delafloxacin was derived from three systematic reviews/meta-analyses. These documents provided a comparative analysis of the drug's safety and effectiveness relative to other antimicrobial drugs.
- In terms of clinical efficacy, delafloxacin demonstrated a cure rate comparable to that of other antibiotics. Its performance was found non-inferior to tigecycline and linezolid, superior in some aspects compared to vancomycin when treating ABSSSIs including those associated with methicillin-resistant Staphylococcus aureus (MRSA).
- The microbiological eradication rate of delafloxacin aligns closely with comparator drugs suggesting it as a potential alternative therapeutic agent for acute bacterial infections including those caused by resistant bacteria.
- Safety profile comparison revealed no significant difference between delafloxacin and comparators regarding treatment-emergent adverse events or serious adverse events. However, incidence rates were higher for diarrhea but lower for nervous system disorders among patients treated with this drug; also, discontinuation due to adverse effects was less frequent than with comparators, indicating better tolerance in some patients.
- While there were no specific mentions of different population types or subgroup analyses such as age, race, or gender within the studies reviewed; studies focusing on adult patients suffering from ABSSSI suggest that this drug could be particularly useful in managing infections caused by resistant bacteria like MRSA.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Baxdela (delafloxacin) Prescribing Information. | 2021 | Melinta Therapeutics Inc., Lincolnshire, IL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| The efficacy and adverse events of delafloxacin in the treatment of acute bacterial infections: a systematic review and meta-analysis of randomized controlled trials. | 2022 | Frontiers in Pharmacology |
| The efficacy and adverse events of delafloxacin for treating acute bacterial skin and skin structure infections: a systematic review and meta-analysis. | 2020 | Journal of Pharmacy & Bioallied Sciences |
| Efficacy and safety of delafloxacin in the treatment of acute bacterial skin and skin structure infections: a systematic review and meta-analysis of randomized controlled trials. | 2019 | Infection and Drug Resistance |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Antimicrobial prescribing: delafloxacin for acute bacterial skin and skin structure infections. | 2021 | National Institute for Health and Care Excellence |
| Delafloxacin: a review in acute bacterial skin and skin structure infections. | 2020 | Drugs |