Fosfomycin as Oral Transition Therapy Versus Continued Intravenous β-Lactams for Complicated Urinary Tract Infections Caused by Extended-Spectrum β-Lactamase-Producing Enterobacterales: A Multicenter, Open-Label, Randomized Controlled Trial.
Jun-Won Seo, Da Young Kim, Youngmin Yoon et al.
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In 30 seconds
This multicenter, open-label randomized noninferiority trial compared oral fosfomycin transition therapy with continued intravenous carbapenem or β-lactam/β-lactamase inhibitor therapy in hospitalized adults with complicated UTIs caused by ESBL-producing Enterobacterales who had improved after 3–7 days of intravenous antibiotics. Among 299 randomized patients, clinical cure was 92.8% with oral fosfomycin and 95.2% with continued intravenous therapy (risk difference, -2.47%; 95% CI -7.84 to 2.89), meeting the trial’s noninferiority criterion. Microbiological cure, safety, and 30-day outcomes were also reported as comparable.
Key findings
- Clinical cure occurred in 92.8% with oral fosfomycin versus 95.2% with intravenous therapy (risk difference, -2.47%; 95% CI -7.84 to 2.89), confirming noninferiority.
- Urine microbiological cure was 98.0% with fosfomycin versus 96.6% with intravenous therapy; blood cure was 97.3% versus 97.5%.
- Safety profiles and 30-day outcomes were comparable between treatment groups.
Why it matters
The trial addresses the need for oral options after initial intravenous treatment of ESBL-producing complicated UTIs, where continued reliance on carbapenems may contribute to resistance. Comparable cure and safety outcomes in this study suggest that oral transition can be a carbapenem-sparing approach for appropriately selected patients who have already improved on intravenous antibiotics.
What to keep in mind
The trial was open-label and conducted at four tertiary hospitals in South Korea; its findings apply to hospitalized adults who improved after 3–7 days of intravenous antibiotics.