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

Keywords

Pelvic inflammatory disease / Levornidazole disodium phosphate / Multicenter / Randomized controlled / Double-blind

Conflict of interest statement

YW, SJ and RW were from Yangtze River Pharmaceutical Group Co, Ltd.. The other authors declare that they have no competing interests.

Ethics approval and consent to participate

The study was conducted according to the Declaration of Helsinki and ethical approval was granted by the First Affiliated Hospital with Nanjing Medical University Medical Ethics Committee (Approval No. 2017-SR-014). Written informed consent was obtained from participants.

Availability of data and materials

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

Funding

The study did not receive any financial support from grants.

Authors’ contributions

YW and RW contributed to study design and drafting of the manuscript. SJ, ZY and LZ contributed to data collection. ZF, XJ and MX contributed to statistical analysis. YL and JK contributed to editing of the manuscript. All authors have read and approved the final manuscript.

Publisher’s note

The Publisher of the Journal remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Edited by Pan Y, Lei Y, Zhang Q

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