The Effect of Cefepime/Fluorothiazinone Compared with Cefepime/Placebo on Clinical Cure and Microbiological Eradication in Patients with Complicated Urinary Tract Infections: A Prospective Randomized Clinical Trial

The multicenter prospective randomized trial of clinical and microbiological efficacy of cefepime in combination with fluorothiazinone or placebo was conducted to expand the possibilities of empirical therapy for patients with complicated urinary tract infections. The primary endpoint of the study in the MITT population was the clinical cure and pathogen eradication on the 21st day after the conclusion of antibacterial therapy: this indicator was 75.6% in cefepim/fluorothiazinone group and 50.8% in cefepim/placebo group; 97.5% one-sided confidential interval (14.7%) exceeded the hypothesis of equal efficacy (0%), allowing an alternative hypothesis of the superiority of cefepime/fluorothiazinone over cefetime/placebo to be accepted. There was a significant (P=0.012) decrease in relapses occurrences of infection at follow-up (90 days after the start of treatment) after the use of cefepime/fluorothiazinone compared with cefepime/placebo, 3/178 (1.7%; 95% CI: 0.3–4.8) and 14/175 (8.0%; 95% CI: 4.4–13.1), respectively. Adverse events were detected in 37 (20.6%; 13.4–25.3) patients in group cefepim/fluorothiazinone and in 27 (15.2%; 8.0–18.2) patients in group cefepim/placebo; their number did not significantly differ, they were not severe and did not require drug discontinuation. The results of the study showed the clinical and microbiological advantages of cefepime/fluorothiazinone combination compared with cefepime/placebo with an equal safety profile, which makes it possible to expand the effectiveness of empirical therapy for complicated urinary tract infections.

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