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Table 4 Outcome measures at Test Of Cure—TOC day 17 ± 1 and on study completion day 33 ± 3

From: The efficacy of pivmecillinam in oral step-down treatment in hospitalised patients with E. coli bacteremic urinary tract infection; a single-arm, uncontrolled treatment study

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
  1. Per-protocol population
  2. 1Body temperature and patient reported outcome measure not done in one patient
  3. 2Urine and blood sample not done in two patients
  4. 3Clostridioides Difficile Infection
  5. *Colony Forming Unit