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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