Drug updated on 12/11/2024
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 the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI)and Community-Acquired Bacterial Pneumonia (CABP)
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Delafloxacin showed no significant difference in clinical cure rate compared to other antibiotics for treating acute bacterial infections in adults, with an odds ratio (OR) of 1.06 (95% confidence interval (CI): 0.89-1.26). Its microbiological eradication rate was also similar to comparators (OR: 1.33, 95% CI: 0.94-1.88).
- For acute bacterial skin and skin structure infections (ABSSSI), delafloxacin was non-inferior to tigecycline and linezolid, and superior to vancomycin in terms of pooled cure rates, with a pooled efficacy of 80% (95% CI: 1.01 [0.97-1.06]).
- Delafloxacin demonstrated a safety profile similar to comparator antibiotics, with no significant differences in treatment-emergent adverse events (OR = 0.93%, 95% CI = 0.80-1.08) or serious adverse events (OR = 0.94%, 95% CI = 0.67-1.32).
- Delafloxacin had a higher incidence of diarrhea (OR = 2.10%, 95% CI = 1.70-2.96) compared to comparators but a lower incidence of nervous system disorders (OR = 0.71%, 95% CI = 0.50-1.01).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Baxdela (delafloxacin) Prescribing Information. | 2021 | Melinta Therapeutics, LLC., Parsippany, New Jersey |
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 |
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 |