Oral Fosfomycin after Carbapenems as De-escalating Therapy in Complicated Urinary Tract Infections: A Randomized Controlled Trial
Abstract
OBJECTIVES
To determine whether oral fosfomycin trometamol is noninferior to carbapenem continuation as step-down therapy for cUTIs caused by third-generation cephalosporin-resistant Enterobacterales.
METHODS
In this open-label, randomized, noninferiority trial, adults with 3GCRE cUTIs who received 3 days of intravenous carbapenem were assigned to oral fosfomycin trometamol or continued carbapenem to complete 7 days. The primary outcome was day-7 clinical cure; secondary outcomes included day-28 clinical and microbiological cure, readmission, and length of stay.
RESULTS
A total of 124 participants were enrolled (62 per group). The mean age was 73 years, 62.1% were female, and Escherichia coli accounted for 91% of isolates. Clinical cure at day 7 occurred in 98.4% in both groups (risk difference 0.0; 95% CI -0.04 to 0.04). Clinical cure at day 28 was also similar (91.9% in each group). Microbiological cure at day 7 was 100% with fosfomycin and 98.1% with carbapenem, and at day 28 was 90.3% and 85.5%, respectively. Hospital stay was shorter with fosfomycin (7.9 vs 12.0 days).
CONCLUSIONS
Oral fosfomycin trometamol as step-down therapy was comparable to continued carbapenem therapy for cUTIs caused by 3GCRE and significantly reduced hospital stay, supporting role of carbapenem-sparing option.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 124 participants or records.
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