Presentation (CTI)

OBJECTIVES: This study evaluated the efficacy and safety of levornidazole disodium phosphate for treating postoperative intra-abdominal infections (PIAIs) involving anaerobic pathogens.
METHODS: This noninferiority trial conducted in China, patients with PIAIs were randomized 1:1 to receive either 1 g Levornidazole Disodium Phosphate for Injection once daily (treatment) or 0.5 g Ornidazole and Sodium Chloride Injection twice daily (control) for 4-7 days. The primary endpoint was the clinical cure rate at the test of cure (TOC) visit. With a non-inferiority margin of -8%. Secondary endpoints included bacteriological eradication rate, overall success rate at both TOC and the end of therapy (EOT) visits, and clinical cure rate at EOT.
RESULTS: The full-analysis set comprised 339 patients (treatment) and 338 patients (control). At TOC, clinical cure rates were 92.33% (treatment) and 93.05% (control) , yielding a between-group difference of -0.72% (95% CI: -4.85, 3.35), demonstrating non-inferiority. Clinical cure rates at EOT, bacteriological eradication rates and overall success rates at EOT and TOC were similar in two groups. Adverse drug reactions occurred in 9.86% (34/345) of the treatment group and 12.17% (42/345) of the control group, showing no statistically significant difference.
CONCLUSIONS: Once-daily Levornidazole Disodium Phosphate for Injection demonstrated non-inferiority to twice-daily Ornidazole and Sodium Chloride Injection in treating PIAIs, Levornidazole Disodium Phosphate for Injection provides a more convenient therapeutic regimen with a comparable tolerability profile.