NCT06828874

A Study of Levornidazole Disodium Phosphate for Injection vs. Ornidazole in Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria

A Prospective, Multicenter, Randomized, Blinded, Positive Parallel Control Study to Estimate the Efficacy and Safety of Levornidazole Disodium Phosphate for Injection in the Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 696 (actual)
• Sponsor: Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anaerobic infections are very common in clinical practice. Poor control of anaerobic infections in patients undergoing abdominal surgery may lead to the occurrence of complications. The aim of this study is to explore the efficacy and safety of Levornidazole Phosphate Disodium for Injection in the treatment of patients with postoperative intra-abdominal infections caused by anaerobic bacteria.

Conditions

• Intraabdominal Infections

Interventions

Type	Name	Description
DRUG	Levornidazole Disodium Phosphate for Injection	1g，once daily, intravenously guttae for 4 to 7 days
DRUG	Ornidazole and Sodium Chloride Injection	0.5g at a time , 2 times per day, intravenously guttae for 4 to 7 days

Timeline

• Start date: 2023-05-10
• Primary completion: 2024-09-23
• Completion: 2024-10-14
• First posted: 2025-02-17
• Last updated: 2025-02-18

Locations

32 sites across 1 country: China