Table 2. Primary and Secondary Outcomes.
| Characteristics | Children, No./total No. (%) | P value | Difference of proportions, % (95% CI) | No. needed to treata | ||
|---|---|---|---|---|---|---|
| Standard-course therapy | Short-course therapy | All children | ||||
| Primary outcome—treatment failure | ||||||
| UTI between day 6 and day 11-14 visit | 2/328 (0.6) | 14/336 (4.2) | 16/664 (2.4) | <.01 | 3.6 (≤5.5)b | 28 |
| Secondary outcomes | ||||||
| UTI after day 11-14 visit | 12/326 (3.7) | 13/322 (4.0) | 25/648 (3.9) | .97 | 0.4 (−2.6 to 3.3) | c |
| Asymptomatic bacteriuria at day 11-14 visit | 11/328 (3.4) | 32/336 (9.5) | 40/664 (6.0) | <.01 | 6.2 (2.5-9.9) | 17 |
| UTI symptoms day 6 through day 11-14 visit | 30/328 (9.1) | 41/336 (12.2) | 71/664 (10.7) | .25 | 3.1 (−1.6 to 7.7) | c |
| Positive urine culture day 6 though day 11-14 visitd | 15/328 (4.6) | 42/336 (12.5) | 47/664 (7.1) | <.01 | 7.9 (3.7-12.1) | 13 |
| Stool antimicrobial resistance at day 24-30 visite | 23/298 (7.7) | 28/310 (9.0) | 51/608 (8.4) | .66 | 1.3 (−3.1 to 5.7) | c |
Abbreviation: UTI, urinary tract infection.
a
Number of children that would need to be treated with standard-course therapy to prevent 1 treatment failure. Confidence interval not presented because, for some outcomes, upper bound is unbounded. This analysis was added post hoc.
b
One-sided confidence interval, therefore only upper bound of is shown; by definition, lower bound is −100.
c
Number needed to treat not presented because difference in proportions was not significant.
d
With or without symptoms.
e
Defined by recovery of antimicrobial-resistant Escherichia coli or Klebsiella pneumoniae from the stool of children in whom these resistant organisms were not present at enrollment.