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Table 3 Clinical and bacteriologic outcomes in the intention-to-treat and per-protocol population

From: Treatment duration of febrile urinary tract infection: a pragmatic randomized, double-blind, placebo-controlled non-inferiority trial in men and women

  Randomized Difference (90% CI) Non-inferiority test P value Not randomized population
Antibiotic treatment for 7 days Antibiotic treatment for 14 days
Intention-to-treat population (n = 94) (n = 99)    
Short-term efficacya (n = 94) (n = 99)    (n = 119)
 Clinical cureb 85 (90.4%) 94 (94.9%) –4.5% (–10.7 to 1.7) 0.072 101 (84.9%)
 Bacteriologic curec 86/93 (92.5%) 89/92 (96.7%) –4.3% (–9.7 to 1.2) 0.041 94/109 (86.2%)
Cumulative efficacyd (n = 94) (n = 94)    (n = 116)
 Clinical cureb 87 (92.6%) 86 (91.5%) 1.1% (–5.5 to 7.6) 0.005 88 (75.9%)
Per-protocol population (n = 92) (n = 92)    
Short-term efficacya (n = 92) (n = 92)    NA
 Clinical cureb 83 (90.2%) 87 (94.6%) –4.3% (–10.8 to 2.1) 0.073  
 Bacteriologic curec 84/91 (92.3%) 83/86 (96.5%) –4.2% (–9.9 to 1.4) 0.045
Cumulative efficacyd (n = 92) (n = 87)   
 Clinical cureb 85 (92.4%) 79 (90.8%) 1.6% (–5.3 to 8.4) 0.005
  1. Data presented as number (%), unless otherwise indicated. NA: not applicable
  2. aShort-term efficacy: endpoints assessed at 10- to 18-days post-treatment visit
  3. bClinical cure: being alive with absence of fever and resolution of UTI symptoms through post-treatment visit with no additional antimicrobial therapy for a relapse of UTI prescribed
  4. cBacteriologic cure: elimination of study entry uropathogen or pathogen growth < 104 CFU/mL (women) or <103 CFU/mL (men) combined with disappearance of leucocyturia
  5. dCumulative efficacy: endpoint assessed at 70- to 84-days post-treatment visit