Table 2

Sample size for single-arm interventional paediatric antibiotic CTs having safety as a primary endpoint, according to the rates of adverse events (AEs) per single drug class reported in the systematic review

Drug classOverall percentage experiencing AEs*Sample size to provide >0.80 probability that final 95% CI around estimated AE rate is no more than 10% above thisUpper 97.5% confidence limit around an observation of 0/N (%)Sample size to provide >0.90 probability that final 95% CI around estimated AE rate is no more than 10% above thisUpper 97.5% confidence limit around an observation of 0/N (%)Sample size to provide >0.95 probability that final 95% CI around estimated AE rate is no more than 10% above thisUpper 97.5% confidence limit around an observation of 0/N (%)
Penicillins131063.41392.61722.1
Aminoglycosides3517.0705.1794.6
Cephalosporins161143.21522.41901.9
Macrolides221352.71802.02291.6
Penicillins+BLI461652.22261.62831.3
Fluoroquinolones361612.32251.62771.3
Carbapenems331582.32141.72701.4
Linezolid611532.42051.82581.4
Glycopeptides751173.11532.41852.0
Sulfonamides+trimethoprim5596.1854.21023.6
Amphenicols4556.5734.9914.0
  • The third, fifth and seventh columns represent the sample size that would provide a >0.80, >0.90 and >0.95 probability, respectively, that the final 95% CI around the estimated percentage experiencing AEs in the new trial was no more than 10% higher than the average rate provided in the second column. The fourth, sixth and eighth columns provide the upper 97.5% confidence limit around an observation of zero AEs of a particular type from this number of children.

  • *Data are expressed as median proportion of overall AEs among the studies included in the systematic review by Pansa et al,3 rounded to the nearest percentage point.

  • BLI, beta lactamase inhibitor; CT, clinical trial.