Efficacy and safety of levornidazole disodium phosphate for the treatment of pelvic inflammatory disease: A multicenter, double-blind, randomized trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Objective: To compare the efficacy and safety of levornidazole and levornidazole disodium phosphate in women with pelvic inflammatory disease. Methods: Women from 12 hospitals in China received a 14-day treatment course comprising 7 days of intravenous therapy followed by 7 days of oral sequential therapy: intravenous levornidazole 0.5 g twice daily (Group A, n =49), levornidazole disodium phosphate 1.0 g once daily (Group B, n =49), or levornidazole disodium phosphate 0.5 g twice daily (Group C, n =46), followed by oral levofloxacin plus ornidazole for 7 days. Results: Of the 144 patients in the full analysis set (FAS), 131 (91.00%) were included in the per-protocol set and 38 (29.00%) were microbiologically valid. In the FAS, clinical cure rates at day 14 were 77.55%, 83.67%, and 82.61% for Groups A, B, and C, respectively ( P =0.745). Bacteriological clearance rates were 76.47%, 93.75%, and 100.00%, respectively ( P =0.248). Drug-related adverse events occurred less frequently in Group B than in Group A (38.78% vs . 61.22%; P =0.025). Conclusions: Daily administration of levornidazole disodium phosphate achieved clinical and bacteriological efficacy comparable to twice-daily levornidazole in women with pelvic inflammatory disease and was associated with significantly fewer drug-related adverse events.
Authors: Yanjun Wang, Shichun Ji, Zhixue You, Li Zhou, Zhenghui Fang, Xuemei Jia, Meiqing Xie, Yangzhi Li, Jiali Kang, Ruwei Wang
Institutions: Yangtze River Pharmaceutical Group (China), Nanjing Medical University, Jiangsu Province Hospital, Westlake University, Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine, Shandong University, Jinan Central Hospital, Nanjing Maternity and Child Health Care Hospital, Sun Yat-sen University, Sun Yat-sen Memorial Hospital, Guangzhou First People's Hospital
Language: English
Subfield: Microbiology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W4401019708