Drug updated on 5/17/2024
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.
Latest News
![loading GIF](/img/news-loading.gif)
Summary
- Delafloxacin (Baxdela) is indicated for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), caused by designated susceptible bacteria.
- Three studies were reviewed, which collectively analyzed data from multiple randomized controlled trials to compare delafloxacin's safety and effectiveness against other antibiotic agents in treating ABSSSI and CABP.
- In terms of clinical efficacy, delafloxacin exhibited a comparable cure rate to comparator antibiotics such as linezolid, tigecycline, and vancomycin. For MRSA-associated ABSSSIs specifically, it showed similar clinical cure rates, underscoring its potential value in treating these challenging infections.
- The analysis revealed no significant difference between delafloxacin's safety profile and comparative antibiotics. However, it was associated with a higher incidence of diarrhea but lower incidence of nervous system disorders, suggesting specific patient subgroups might benefit more from this drug.
- Even though explicit mentions about population subgroups were limited within the studies; adult patients suffering from acute bacterial infections, particularly those at risk for or suffering from MRSA-associated infections, could potentially benefit most effectively from this drug.
- Compared to other drugs like linezolid and tigecycline used in the treatment of ABSSSI, delafloxacin demonstrated non-inferiority and even showed superiority over vancomycin, making it an essential consideration due to its better tolerability highlighted by lower discontinuation rates due to adverse events.
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 |