Prulifloxacin vs fosfomycin for prophylaxis in female patients with recurrent UTIs: a non-inferiority trial

Elisabetta Costantini, Alessandro Zucchi, Eleonora Salvini, Annarita Cicalese, Vincenzo Li Marzi, Maria T eresa Filocamo, Vittorio Bini, Massimo Lazzeri

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INTRODUCTION AND HYPOTHESIS: This multicentre, randomised, non-blinded, parallel group study is designed to assess the null hypothesis that a 3-month prophylactic schedule with fosfomycin is not inferior to prulifloxacin in reducing the number of urinary tract infection episodes during and after prophylaxis in female patients with recurrent urinary tract infections (rUTIs).

METHODS: One hundred and fifty-two patients with rUTIs who were candidates for prophylaxis therapy were enrolled and randomised to prulifloxacin (group 1) or fosfomycin (group 2). The prophylaxis regimen included a single dose of fosfomycin (one 3-g cachet) per week, or a single dose (600 mg) of prulifloxacin (one tablet) a week for 12 weeks. The inclusion criteria were female patients over 18 years, urine culture responsiveness to drugs at patient recruitment and history of rUTI. Exclusion criteria were pregnancy and counter-indications to this drug therapy. Patients were prospectively randomised. Check-ups were scheduled at 2 weeks, 1 month and 3 months from the beginning of the study and 3, 6, and 12 months after suspension of the therapy. The primary end-points were the reduction of the number of UTIs (negative urine culture) during and after prophylaxis.

RESULTS: Final data analysis included 67 patients in group 1 and 57 in group 2. Nine out of 76 patients (group 1) and 19 out of 76 (group 2) dropped out. UTI episodes were significantly reduced in number compared with before prophylaxis (p 

CONCLUSIONS: Both drugs provided adequate prophylaxis in patients with rUTIs, with no difference in efficacy.

Original languageEnglish
Pages (from-to)1173-1178
Number of pages6
JournalInternational Urogynecology Journal and Pelvic Floor Dysfunction
Issue number9
Publication statusPublished - Sep 1 2014

ASJC Scopus subject areas

  • Medicine(all)


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