FOSFOMYCIN TROMETAMOL VERSUS OFLOXACIN COTRIMOXAZOLE AS SINGLE DOSE THERAPY OF ACUTE UNCOMPLICATED URINARY-TRACT INFECTION IN FEMALES - A MULTICENTER STUDY

20 urologists took part in a single blind, randomized study. Female patients with acute uncomplicated UTI were recruited. The patients received either a single dose of 3 g fosfomycin trometamol versus 200 mg ofloxacin or 1.92 g cotrimoxazole. Follow-up examinations were carried out after one and four weeks. Of 562 patients 446 could be evaluated for efficacy and 496 for tolerance. Patients were analysed according to the amount of bacteriuria: "significant" (≥ 105/ml), "low count" (102-104 ml) and "no bacteriuria" (≤ 101/ml), as well as according to the sensitivity of the infecting organisms: sensitive (resistant): fosfomycin trometamol ≤ 16 mg/l (≥ 128 mg/l), ofloxacin ≤ 1 mg/l (≥ 8 mg/l), co-trimoxazole ≤ 2/38 mg/l (≥ 16/304 mg/l). Up to one week the following results could be achieved: clinical improvement was attained in patients with "significant" bacteriuria (fosfomycin trometamol-150, ofloxacin-89, co-trimoxazole -69) in 94.7% for fosfomycin trometamol, in 95.4% for ofloxacin, and in 94% for co-trimoxazole; in patients with "low count" bacteriuria (fosfomycin trometamol-44, ofloxacin-18, co-trimoxazole-30) in 95.2% for fosfomycin trometamol, in 93.7% for ofloxacin, and in 96.4% for co-trimoxazole; and in patients with no bacteriuria (fosfomycin trometamol-11, ofloxacin-6, co-trimoxazole-4) in 81.8% for fosfomycin trometamol, in 100% for ofloxacin and in 100% for co-trimoxazole. Sterile urine or non-significant bacteriuria was achieved in the group with "significant" bacteriuria in 87.4% for fosfomycin trometamol, in 91% for ofloxacin and in 88.4% for co-trimoxazole; and in the group with "low count" bacteriuria in 86.4% for fosfomycin trometamol, in 94.4% for ofloxacin, and in 96.7% for cotrimoxazole. In patients infected by resistant (intermediary sensitive) strains sterile urine or non-significant bacteriuria could be achieved in 7/11 (5/6) patients for fosfomycin trometamol and 2/5 (0/1) for co-trimoxazole. Concerning side effects a total of 6.8% for fosfomycin trometamol, 5.9% for ofloxacin and 7.9% for co-trimoxazole was experienced mostly at the gastrointestinal site (fosfomycin trometamol-6.4%, ofloxacin-5.9%, co-trimoxazole-6.3%). This study demonstrates that fosfomycin trometamol was equally effective and tolerable in single-dose therapy of acute uncomplicated UTI in females when compared to other established drugs such as ofloxacin and co-trimoxazole. © 1990 MMV Medizin Verlag GmbH.