Abstract
Background
Delafloxacin (DLX) is an IV/oral anionic fluoroquinolone with no QT restrictions. It is approved for the treatment of serious skin infections including those due to MRSA and Gram-negative pathogens. A Phase 3 trial of patients with CABP was recently completed comparing DLX to moxifloxacin (MOX), including patients with diabetes (DM).
Methods
Multicenter, randomized, double-blind trial of adults with CABP with at least 2 clinical symptoms; physical signs; and radiographic evidence of pneumonia. Patients were randomized 1:1 to DLX or MOX treatment for 5–10 days. Patients received a minimum of 3 days of IV treatment, then were switched to oral at MD discretion. Key endpoints were the Early Clinical Response (ECR) at 96 ±24h and the investigator assessment of response at Test of Cure (TOC) 5–10 days after last dose in the Intent to Treat population. Clinical success was defined as complete or near resolution of signs and symptoms and no further antibiotics needed per investigator assessment.
Results
131 DM patients were randomized. Patient characteristics: 59% male; mean age 66 (26% ≥ age 75); 40% PORT class IV/V; 29% multi-lobar pneumonia. Bacterial pathogens were identified in 59% at baseline. Patients received treatment ~8.5 days. DLX was comparable to MOX in patients with DM, with response at ECR 90% DLX vs. 88.5% MOX [1.5 (95% CI -9.6, 13.2)] as well as Clinical Success at TOC 87.1% DLX vs. 86.9% MOX [0.3 (95% CI −11.6, 12.7)]. The overall % of DM patients with at least one treatment-related adverse event (AE) was 18.6% DLX and 11.7% MOX. The most frequent treatment-related adverse events were gastrointestinal in nature including diarrhea seen in 6 DLX and 2 MOX patients.There were 3 DLX and 2 MOX deaths of patients with DM during the study (up to Day 28), unrelated to treatment. There were no cases of C diff in these patients. There were no reports of hypoglycemia on DLX. There was one discontinuation of treatment due to a related AE in each treatment group.
Conclusion
IV/oral DLX was comparable to IV/oral MOX for treatment of CABP in patients with diabetes. DLX has no preclinical signals for QT prolongation and has no QT prolongation in a validated challenge study. There were no events of hypoglycemia. DLX appears effective and well tolerated in patients with diabetes and CABP.
Disclosures
All authors: No reported disclosures.
Session: 244. Bacterial Respiratory Infections
Saturday, October 5, 2019: 12:15 PM