Table 2.
Secondary End Points of the Intention-to-Treat Population
| Secondary End Point | Fosfomycin (n=48) | Ciprofloxacin (n=49) | Risk Difference (95% Confidence Interval/P Value) |
|---|---|---|---|
| 6–10 days post-end of therapy | |||
| Microbiological cure | 29/37 (78.4%) | 33/35 (94.3%) | –16.2% (–32.7% to –0.0%) |
| 30–35 days post-end of therapy | |||
| Clinical cure | 35/47 (74.5%) | 33/44 (75.0%) | 0.4% (–18.4% to 17.6%) |
| Reinfection | 4/47 (8.5%) | 7/44 (15.9%) | –7.8% (–22.3% to 6.6%) |
| Relapse | 2/47 (4.3%) | 0/44 | 5.2% (–4.0% to 14.3%) |
| Additional antibiotic therapy for presumed urinary tract infection | 6/47 (12.8%) | 7/44 (15.9%) | –3.4% (–18.6% to 11.9%) |
| Length of hospital stay, mean (SD), days | 4.4 (1.2) | 5.4 (2.5) | P=.9156a |
| Hospital readmission (any cause) | 3/48 (6.3%) | 1/49 (2.0%) | 5.0% (–5.3% to 15.2%) |
| Absenteeism daysb mean (SD) | 3.0 (6.7) | 2.5 (7.0) | P=.5508c |
| Intensive care unit admissiona | 1/48 (2.1%) | 0/49 | 2.9% (–5.3% to 11.0%) |
| Mortality (any cause) | 2/48 (4.2%) | 0/49 | 5.4% (–3.3% to 14.0%) |
| Mortality (probably related) | 0/48 | 0/49 | NA |
Abbreviation: SD, standard deviation.
After randomization.
Number of days absent from paid or voluntary work.
Calculated using a Mann-Whitney test.