Trial reportBMC infectious diseases2026
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).
Trial report in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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36 authors.
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Abstract
background and purposeLevornidazole 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.
methodsThis 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.
resultsThe 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.
conclusionsOnce-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.
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