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Background and Purpose <p>Levornidazole is an ornidazole derivative effective against anaerobic pathogens. Levornidazole disodium phosphate, the disodium phosphate salt of levornidazole, exhibits higher water solubility compared to levornidazole. This study aimed to evaluate the efficacy and safety of levornidazole disodium phosphate in patients with intra-abdominal infections (IAIs) caused by anaerobic pathogens.</p> Methods <p>This non-inferiority trial enrolled patients with IAIs in China, randomized 1:1 to either 1 g levornidazole disodium phosphate intravenously once daily (levornidazole group) or 0.5 g ornidazole and sodium chloride intravenously twice daily (control group) for 4–7 days. The primary endpoint was the clinical cure rate at the test-of-cure (TOC) visit. The non-inferiority margin was −8%. Secondary endpoints included the bacterial eradication rate, overall success rate at both TOC and the end of therapy (EOT) visits, and clinical cure rate at the EOT visit.</p> Results <p>The full analysis set included 339 patients in the levornidazole group and 338 patients in the control group. At TOC, the clinical cure rates were 92.33% in the levornidazole group and 93.05% in the control group, with a between-group difference of −0.72% (95% CI: −4.85, 3.35). Clinical cure rates at EOT, bacteriological eradication rates, and overall success rates at EOT and TOC were similar in the two groups. The incidence of adverse drug reactions was 9.86% (34/345) in the levornidazole group and 12.17% (42/345) in the control group.</p> Conclusions <p>Once-daily levornidazole disodium phosphate was non-inferior to twice-daily ornidazole and sodium chloride for treating IAI, offering a more convenient, better-tolerated option due to its lower dosing frequency.</p>

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Efficacy and safety of levornidazole disodium phosphate injection in patients with intra-abdominal infections caused by anaerobic bacteria: a multicenter, randomized, single-blind, phase IV, non-inferiority trial (ANAEROGUARD study)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月28日

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  • Lin Chen,
  • Lei Zhang,
  • Rufu Chen,
  • Zhiwei Zheng,
  • Li Zhou,
  • Xiufang Zhu,
  • Yuanyuan Wang,
  • Desheng Ni,
  • Xiang Chen,
  • Shuguang Zhao,
  • Yuhuai Zhou,
  • Chuxiao Shao,
  • Jian Xu,
  • Feng Sun,
  • Guoying Wang,
  • Tao Zhao,
  • Xiaorong Li,
  • Quan Wang,
  • Shuanghai Liu,
  • Jiaqing Cao,
  • Yang Fu,
  • Jianxin Ye,
  • Bin Wang,
  • Youming Ding,
  • Wei Wang,
  • Yunjie Zhang,
  • Bo Huang,
  • Jianzhao Huang,
  • Wei Han,
  • Wenxian Guan,
  • Jialin Zhang,
  • Zhongtao Zhang,
  • Jiren Yu,
  • Jiaojiao Yang,
  • Yong Lan,
  • Xiaoping Chen

摘要

Background and Purpose

Levornidazole is an ornidazole derivative effective against anaerobic pathogens. Levornidazole disodium phosphate, the disodium phosphate salt of levornidazole, exhibits higher water solubility compared to levornidazole. This study aimed to evaluate the efficacy and safety of levornidazole disodium phosphate in patients with intra-abdominal infections (IAIs) caused by anaerobic pathogens.

Methods

This non-inferiority trial enrolled patients with IAIs in China, randomized 1:1 to either 1 g levornidazole disodium phosphate intravenously once daily (levornidazole group) or 0.5 g ornidazole and sodium chloride intravenously twice daily (control group) for 4–7 days. The primary endpoint was the clinical cure rate at the test-of-cure (TOC) visit. The non-inferiority margin was −8%. Secondary endpoints included the bacterial eradication rate, overall success rate at both TOC and the end of therapy (EOT) visits, and clinical cure rate at the EOT visit.

Results

The full analysis set included 339 patients in the levornidazole group and 338 patients in the control group. At TOC, the clinical cure rates were 92.33% in the levornidazole group and 93.05% in the control group, with a between-group difference of −0.72% (95% CI: −4.85, 3.35). Clinical cure rates at EOT, bacteriological eradication rates, and overall success rates at EOT and TOC were similar in the two groups. The incidence of adverse drug reactions was 9.86% (34/345) in the levornidazole group and 12.17% (42/345) in the control group.

Conclusions

Once-daily levornidazole disodium phosphate was non-inferior to twice-daily ornidazole and sodium chloride for treating IAI, offering a more convenient, better-tolerated option due to its lower dosing frequency.