- In the treatment of community-acquired bacterial pneumonia (CABP), delafloxacin had comparable outcomes to moxifloxacin regardless of subgroup or pathogen.
Why this matters
- Delafloxacin has no QT restrictions, phototoxicity, food restrictions, or major drug-drug interactions.
- 860 patients randomly assigned 1:1 in a double-blind, active-controlled phase 3 study comparing delafloxacin to moxifloxacin in patients with CABP.
- All patients were treated for a mean 8.5 days (6.3 days intravenous, 2.2 days oral).
- Early clinical response was assessed 96±24 hours after first dose.
- Outcomes analyzed by subgroups including age, sex, risk factor, and bacterial pathogen.
- Funding: Melinta Therapeutics.
- Delafloxacin and moxifloxacin arms had similar demographics and were predominantly male and white, with 13%-14% having a history of COPD/asthma.
- Response rates in delafloxacin (383/431) and moxifloxacin (381/428) arms were not significantly different.
- Response rate difference of −0.2 slightly favored moxifloxacin (95% CI, −4.4 to 4.1).
- More adverse events occurred in delafloxacin arm (30.5% vs 26.2%).
- Most common adverse events (AEs) were diarrhea, increased transaminase, and headache.
- Delafloxacin arm had higher rates of AEs leading to drug discontinuation (3.5% vs 1.6%).
- Outcomes were consistent regardless of subgroup or pathogen identified.
- Results may not be generalizable to all demographics.