Efficacy and safety of levornidazole disodium phosphate for the treatment of pelvic inflammatory disease: A multicenter, double-blind, randomized trial

Abstract

Background In this multicenter, double-blind, randomized, parallel-group study, the efficacy and safety of levornidazole and levornidazole disodium phosphate for the treatment of women with pelvic inflammatory disease (PID) were compared. Methods The women from 12 hospitals in China received a 14-day course of intravenous levornidazole at 0.5 g twice a day (Group A, n = 49) or intravenous levornidazole disodium phosphate at 1.0 g once a day (Group B, n = 49) or 0.5 g twice a day (Group C, n = 46). Results Overall, of the 144 patients in the full analysis set (FAS), 91.00% (n = 131) were included in the per-protocol set; further, 38 of these cases (29.00%) were microbiologically valid. In the FAS population, the 14-day clinical cure rates were 77.55% for Group A, 83.67% for Group B, and 82.61% for Group C (P = 0.7446). The 14-day bacteriological clearance rates in the FAS population were 76.47% for Group A, 93.75% for Group B, and 100.00% for Group C (P = 0.2476). Drug-related adverse events occurred less frequently in Group B (38.78%) than in Group A (61.22%; P = 0.025). Conclusions These results indicate that daily administration of levornidazole disodium phosphate as a concentration-dependent antibacterial agent antibacterial agent for 14 days was as clinically and bacteriologically efficacious for women with PID as levornidazole twice daily for 14 days. Moreover, the former was associated with significantly fewer drug-related adverse events. Trial registration: ChiCTR2300073123 registered on 03/07/2023 (https://www.chictr.org.cn/showproj.html?proj=196700).