A multicenter, open-label, randomized controlled clinical trial to compare biapenem with meropenem in the treatment of bacterial pneumonia and urinary tract infections

Objective To evaluate the efficacy and safety of biapenem versus meropenem in the treatment of bacterial pneumonia and urinary tract infections. Methods In this multicenter, open-label, randomized controlled clinical trial, patients with bacterial pneumonia or urinary tract infections were assigned randomly to receive biapenem or meropenem. Results The overall clinical efficacy rates of biapenem and meropenem were 87.0% (107/123) and 90.1% (109/121) respectively. Specifically, the efficacy rates were 90.0% (63/70) vs. 91.9% (57/62) for bacterial pneumonia, and 83.0% (44/53) vs. 88.1% (52/59) for urinary tract infections, respectively. The overall bacterial eradication rates of biapenem and meropenem were 96.3% (77/80) and 98.8% (79/80) respectively, specifically 100% (42/42) vs. 100% (39/39) for bacterial pneumonia, and 92.1% (35/38) vs.97.6% (40/41) for urinary tract infections. The incidence of adverse reaction was 4.7% (6/129) in biapenem group and and 3.1% (4/128) in meropenem group. The incidence of drug-related laboratory abnormality was 17.1% (22/129) in biapenem group and 19.5% (25/128) in meropenem group. Discontinuation due to adverse reaction was reported in 2 (1.6%) patients of biapenem group and 4 (3.1%) patients of meropenem group. No statistically significant difference was found between the two groups in terms of efficacy rate, bacterial eradication rate or incidence of adverse reaction. Conclusions Biapenem is effective and well-tolerated in treating bacterial pneumonia and urinary tract infection, which is comparable to meropenem in terms of efficacy and safety.