This article is part of Pulmonology Advisor‘s coverage of the CHEST 2019 meeting, taking place in New Orleans, LA. Our staff will report on medical research related to asthma, COPD, critical care medicine, and more conducted by experts in the field. Check back regularly for more news from CHEST 2019.
NEW ORLEANS — Delafloxacin may provide a feasible alternative antibiotic monotherapy option for treating patients with community-acquired bacterial pneumonia (CABP) who have renal impairment in both the inpatient and outpatient settings, according to the results of a study presented at the CHEST Annual Meeting 2019, held October 19 to 23 in New Orleans, Louisiana.
Delafloxacin is an anionic fluoroquinolone antibiotic available in both oral and intravenous (IV) formulations. Of note, unlike the other members of this class of medication, delafloxacin does not have QT restrictions; it is approved for the treatment of serious skin infections in the United States.
Researchers conducted a phase 3, multicenter, randomized, double-blind trial of adults with CABP and renal insufficiency to compare the safety and effectiveness of delafloxacin with that of moxifloxacin. A total of 447 patients were randomly assigned in a 1:1 ratio to receive either delafloxacin or moxifloxacin for 5 to 10 days. Patients were switched from IV to oral therapy after 3 days at the physicians’ discretion. The clinical end points were investigator assessment of clinical success at test of cure visit (5-10 days after the end of treatment) and all-cause mortality at day 28.
Results demonstrated that 32.6% and 29.7% of patients with renal insufficiency in the delafloxacin and moxifloxacin groups, respectively, had >1 treatment-emergent adverse events. The most common adverse events associated with delafloxacin use were gastrointestinal or hepatic in nature, and none led to the discontinuation of treatment. However, serious adverse events did lead to discontinuation in 6 patients in the delafloxacin group compared with 3 in the moxifloxacin group. Further, there were no preclinical signs of QT prolongation in patients who received delafloxacin; of note, this finding was validated in a challenge study.
The researchers concluded that both oral and IV formulations of delafloxacin were comparable in safety and effectiveness with oral and IV formulations of moxifloxacin in the treatment of CABP in patients with renal impairment.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Cammarata S, Mindiashvili L, Horcajada JP, Lawrence L, Quinta M, Cheng C-Y. Treatment of community-acquired bacterial pneumonia in patients with renal impairment: outcomes from a global phase-3 study of delafloxacin. Presented at: CHEST Annual Meeting 2019; October 19-23, 2019; New Orleans, LA.