Single-dose fosfomycin trometamol (Monuril) versus multiple-dose norfloxacin: results of a multicenter study in females with uncomplicated lower urinary tract infections.

The results of an open, randomized study comparing the efficacy and safety of Fosfomycin trometamol (Monuril), 3-gram single dose, and Norfloxacin (Noroxine 400), 400 mg twice daily for 5 days, are reported. Clinical and bacteriological assessments were performed before and 3-4 (short-term) and 25-30 days (long-term) after treatment. Only female patients with uncomplicated lower urinary tract infection were eligible for inclusion in the study: 33 cases were given Fosfomycin trometamol and 30 cases Norfloxacin. In the overall etiology, Escherichia coli (74% of the strains found), Proteus mirabilis (6%) and Klebsiella pneumoniae (6%) are highly predominant. With regard to bacteriological efficacy, the percentages of eradication in the two groups were similar: after the short-term test, 93.9% (31 of 33 patients) in the Fosfomycin trometamol group and 86.6% (26 of 30) in the Norfloxacin group, and after the long-term tests, 73.3% (22 of 30) in the Fosfomycin trometamol group and 77.89% (21 of 27) in the Norfloxacin group. There are no statistically significant differences. The duration of the reported side effects was significantly lower in the Fosfomycin trometamol group. The simplified dosage regimen (single dose) and its favorable benefit/risk ratio justifies the use of Fosfomycin trometamol as a treatment for uncomplicated urinary tract infections in female patients.