Drug updated on 9/4/2024
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.
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Summary
- Baxdela (delafloxacin) is indicated for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria, and for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Clinical Cure Rate: Delafloxacin exhibited clinical cure rates similar to comparator drugs in both ABSSSI treatment (OR = 1.05, 95% CI = 0.87-1.27, I² = 16%) and MRSA-associated ABSSSIs (OR = 1.12, 95% CI = 0.71-1.77, I² = 0%).
- Microbiological Eradication: The microbiological eradication rate of delafloxacin was comparable to that of comparator drugs in ABSSSIs (OR = 1.21, 95% CI = 0.58-2.50, I² = 0%) and MRSA-associated ABSSSIs (OR = 1.16, 95% CI = 0.37-3.60, I² = 0%).
- Comparison to Other Drugs: Delafloxacin was found to be non-inferior to tigecycline and linezolid and superior to vancomycin in pooled cure rates for ABSSSI.
- No significant differences were observed in treatment-emergent adverse events (TEAEs) between delafloxacin and comparators (OR = 0.93, 95% CI = 0.80-1.08, I² = 75%). Delafloxacin showed a lower incidence of nervous system disorders (OR = 0.71, 95% CI = 0.50-1.01, I² = 52%) but a higher incidence of diarrhea (OR = 2.10, 95% CI = 1.70-2.96, I² = 0%).
- Delafloxacin had a lower risk of discontinuation due to adverse events (AEs) compared to comparators (OR = 0.33, 95% CI = 0.15-0.74, I² = 0%).
- There is no population type or subgroup information available in the reviewed studies.
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 |