Patients in 3 (1 phase 2 and 2 phase 3) comparator-controlled clinical trials were randomized to receive eravacycline 1 mg/kg intravenously (IV) every 12 hours, ertapenem 1 g IV every 24 hours, or meropenem 1 g IV every 8 hours for 4 to 14 days, and investigators conducted a pooled safety analysis from these trials. A total of 576 patients were treated with eravacycline 1 mg/kg IV every 12 hours and 547 patients were treated with comparators (ertapenem or meropenem). Demographic and baseline characteristics were similar among the groups. The eravacycline-treated population included 28% obese patients (BMI ≥30 kg/m2) and 7.6% with baseline moderate-to-severe renal impairment.
The overall rate of treatment-emergent adverse events (TEAEs) was 37.7% for eravacycline and 27.8% for the comparator group. The most frequent TEAEs associated with eravacycline versus the comparators were nausea (6.9% vs 0.9%), infusion-site reactions (6.8% vs 1.8%), vomiting (3.5% vs 2.4%), wound infection (2.6% vs 1.1%), diarrhea (2.3% vs 1.5%), anemia (1.9% vs 2.9%), pyrexia (1.9% vs 2.0%), and hypertension (1.6% vs 2.4%). Among the eravacycline group, 5.7% reported serious TEAEs; the rate of serious TEAEs was 6.0% in the comparator group. TEAEs leading to discontinuation of the study drug were 1.6% versus 2.2%, respectively, and TEAEs leading to death were 1.2% versus 1.3% for eravacycline versus comparators, respectively. Pooled analysis data demonstrated that eravacycline 1 mg/kg every 12 hours is generally well-tolerated for the treatment of complicated intra-abdominal infections when compared with ertapenem and meropenem.
Source: Efimova E, et al. IDWeek 2018. Abstract 1976.