A multinational, open-label, analyst-blinded, clinical trial 2 included 513 nonpregnant women aged 18 years and older with symptoms of lower UTI, a positive urine dipstick result, and no known colonization or previous infection with resistant uropathogens. Women were randomized in a 1:1 ratio to oral nitrofurantoin, 100 mg 3 times a day for 5 days, or a single 3-g dose of oral fosfomycin. Clinical resolution through day 28 was achieved in 171 of 244 patients (70%) receiving nitrofurantoin vs 139 of 241 patients (58%) receiving fosfomycin (difference 12%, 95% CI 4% to 21%). Microbiologic resolution occurred in 129 of 175 (74%) vs 103 of 163 (63%), respectively (difference 11%, 95% CI 1% to 20%). Adverse events were few and primarily gastrointestinal; the most common were nausea and diarrhea (7/248 and 3/248 in the nitrofurantoin group vs 5/247 and 5/247 in the fosfomycin group, respectively).
A Cochrane review [Abstract] 1 included 21 studies with a total of 6016 subjects. Different antimicrobial treatments (7 days) for acute uncomplicated lower UTI were compared. Short-term cure was defined as absence of urinary symptoms up to 2 weeks after start of treatment or negative urine culture within 2 weeks, and long-term follow-up was up to 8 weeks. For symptomatic cure, no difference was found between different antimicrobial treatments (trimethoprim-sulfamethoxazole (TMP-SMX), fluoroquinolones, beta-lactam drugs, and nitrofurantoin), see table T1. For bacteriological cure, fluoroquinolones were more effective than beta-lactams in short-term, but not more effective than TMP-SMX. Rashes were more frequent with TMP-SMX than with nitrofurantoin or fluoroquinolones and with beta-lactam drugs compared to fluoroquinolones. Minimal data were available on resistant strains during or after antimicrobial treatment.
Clinical comment: Consider the drug resistance when choosing the treatment. Fluoroquinolones are not recommended for lower UTI.
| Studies | Patients | Intervention | Control | Outcome | Risk ratio and 95% Cl | Outcome in words |
|---|---|---|---|---|---|---|
| Symptomatic cure | ||||||
| 5 RCTs | 927 | fluoroquinolone | TMP-SMX | Short-term | RR 1.00 (0.97 to 1.03) | No difference |
| 1 RCT | 614 | fluoroquinolone | TMP-SMX | Long-term | RR 0.99 (0.94 to 1.05) | No difference |
| 2 RCTs | 176 | beta-lactams | TMP-SMX | Short-term | RR 0.95 (0.81 to 1.12) | No difference |
| 2 RCTs | 138 | beta-lactams | TMP-SMX | Long-term | RR 1.06 (0.93 to 1.21) | No difference |
| 3 RCTs | 733 | nitrofurantoin | TMP-SMX | Short-term | RR 0.99 (0.95 to 1.04) | No difference |
| 2 RCTs | 338 | nitrofurantoin | TMP-SMX | Long-term | RR 1.01 (0.94 to 1.09) | No difference |
| 1 RCT | 51 | nitrofurantoin | beta-lactams | Short-term | RR 1.19 (0.93 to 1.51) | No difference |
| 2 RCTs | 1192 | fluoroquinolone | beta-lactams | Short-term | RR 1.15 (0.99 to 1.32) | No difference |
| Bacteriological cure | ||||||
| 5 RCTs | 1289 | fluoroquinolone | beta-lactams | Short-term | RR 1.22 (1.13 to 1.31) | Fluoroquinolones slightly more effective than beta-lactams |
| 7 RCTs | 1253 | fluoroquinolone | TMP-SMX | Short-term | RR 1.03 (1.00 to 1.07) | No difference |
| 6 RCTs | 884 | fluoroquinolone | TMP-SMX | Long-term | RR 1.06 (1.00 to 1.12) | No difference |
| 5 RCTs | 389 | beta-lactams | TMP-SMX | Short-term | RR 0.95 (0.88 to 1.04) | No difference |
| 5 RCTs | 311 | beta-lactams | TMP-SMX | Long-term | RR 0.97 (0.87 to 1.08) | No difference |
| 2 RCTs | 170 | nitrofurantoin | beta-lactams | Short-term | RR 1.09 (0.75 to 1.58) | No difference |
| 2 RCTs | 143 | nitrofurantoin | beta-lactams | Long-term | RR 0.97 (0.86 to 1.09) | No difference |
| 4 RCTs | 668 | nitrofurantoin | TMP-SMX | Short-term | RR 0.97 (0.87 to 1.08) | No difference |
| 3 RCTs | 395 | nitrofurantoin | TMP-SMX | Long-term | RR 1.01 (0.90 to 1.13) | No difference |
Primary/Secondary Keywords