BMI does not modify safety, efficacy of fixed-dose omadacycline for CABP
The fixed-dosing omadacycline strategy demonstrates consistent safety and efficacy in patients with community-acquired bacterial pneumonia (CABP), regardless of body mass index (BMI), according to a phase III trial.
A total of 756 patients hospitalized for suspected CABP were randomized to receive intravenous omadacycline or moxifloxacin, with an optional transition to oral, for 7 to 14 days. Of these, 278 patients were of normal weight (BMI <18.5 kg/m2; n=138 and n=140 in the respective treatment arms), 266 were overweight (BMI 25 kg/m2 to <30 kg/m2; n=131 and n=135), and 212 were obese (BMI ≥30 kg/m2; n=104 and n=108).
Clinical success rates 72–120 hours after receipt of the first dose were similar in both treatment arms and across BMI categories: 82.9 percent, 80.5 percent, and 76.9 percent normal weight, overweight, and obese patients in the omadacycline arm. The corresponding numbers in the moxifloxacin arm were 88.6 percent, 80.7 percent, and 76.9 percent.
Results were consistent in an analysis stratified by diabetes status, with generally similar clinical success rates in the two treatment groups. Patients who achieved early clinical success or clinical stability generally showed continued clinical success at 5–10 days after the last dose (post-treatment evaluation).
Safety profiles of omadacycline and moxifloxacin were largely comparable across BMI subgroups and by diabetes history.