Table 4 Outcome measures at Test Of Cure—TOC day 17 ± 1 and on study completion day 33 ± 3
Primary outcome—TOC—day 17 ± 1 | n/N | % |
|---|---|---|
Clinical efficacy1 | ||
Afebrile | 49/49 | 100.0 |
No need for re-treatment | 45/50 | 90.0 |
Improved health status | 46/49 | 93.9 |
Composite primary end-point (all three above) | 44/50 | 88.0 95% CI [75.7–95.5] |
Secondary outcome—TOC—day 17 ± 1 | ||
Bacteriologic result—urine culture2 | ||
No growth (< 103 CFU*/mL) | 19/48 | 39.6 |
E. coli 103 → 105 CFU/mL | 14/48 | 29.2 |
Other uropathogen | 2/48 | 4.2 |
Mixed flora/contaminated | 13/48 | 27.1 |
C-reactive protein (mg/L)2 | ||
< 30 | 43/48 | 89.6 |
≥ 30 | 5/48 | 10.4 |
Secondary outcome measures—day 33 ± 3 | ||
Readmission due to UTI < 1 month after discharge | 4/50 | 8.0 |
Including 2 patients readmitted prior to TOC | ||
Including 1 patient treated with elective transurethral bladder biopsy | ||
Readmission for other reasons < 1 month after discharge | 4/50 | 8.0 |
Calculous cholecystitis = 1 | ||
Spondylodiscitis = 1 | ||
Rectal hemorrhage = 1 | ||
Observation for abdominal pain = 1 | ||
Treatment-requiring UTI < 1 month after discharge | 6/50 | 12.0 |
Death < 1 month after discharge | 0/50 | 0.0 |
Occurrence of CDI3 | 1/50 | 2.0 |