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Table 3 Clinical outcomes in the modified intention-to-treatment (MITT) and validated per protocol (VPP) populations

From: Comparison of ceftriaxone plus macrolide and ampicillin/sulbactam plus macrolide in treatment for patients with community-acquired pneumonia without risk factors for aspiration: an open-label, quasi-randomized, controlled trial

 CTRXABPC/SBTRisk Difference % (95% CI)p-value
MITT population, n124139  
Treatment period, days±SD7.8 ± 3.28.2 ± 3.7 0.245*
 Day 4, effective, n (%)106 (88) (121 cases)130 (96) (135 cases)−8.7 (−15.4–-2.0)0.011
 Day 7, effective, n (%)105 (88) (120 cases)126 (97) (130 cases)−9.4 (−16.0–-2.8)0.007
 EOT, effective, n (%)108 (87)130 (94)−7.1 (−14.2–0.0)0.055
 EOS, cure, n (%)102 (83)126 (91) 0.187
 EOS, relapse, n (%)5 (4.0)3 (2) 
 EOS, failure, n (%)17 (14)10 (7) 
 Death within 30 days, n (%)4 (3)0 (0)3.2 (0.1–6.3)0.048
 VPP population, n104108  
Treatment period, days±SD7.9 ± 2.98.3 ± 3.3 0.387*
 Day 4, effective, n (%)95 (91)105 (97)−5.9 (−12.1–0.4)0.079
 Day 7, effective, n (%)94 (90)105 (97)−6.8 (−13.3–-0.4)0.047
 EOT, effective, n (%)94 (90)104 (96)−5.9 (−12.6–0.8)0.072
 EOS, cure, n (%)89 (86)102 (94) 0.053
 EOS, relapse, n (%)5 (5)1 (1) 
 EOS, failure, n (%)10 (10)5 (5) 
 Death within 30 days, n (%)1 (1)0 (0)1.0 (−0.9–2.8)0.491
  1. CTRX Ceftriaxone, ABPC/SBT Ampicillin/sulbactam, CI Confidence interval, EOT End of treatment, EOS End of study. Relapse was defined as cases with recurrent fever after day 7 after primarily being judged as improving by EOT. Comparisons were conducted using the chi-squared test unless otherwise indicated. *Student’s t-test. Fisher’s exact test