Table 2.
Clinical Outcomes According to Study Group.
| Outcome | Trimethoprim–Sulfamethoxazole | Placebo | Absolute Difference in Risk (95% CI) |
|---|---|---|---|
| no. of children/total no. (%) | percentage points | ||
| Recurrent febrile or symptomatic UTI* | |||
|
| |||
| Children with missing 2-yr data classified as having had an event (intention-to- treat analysis) | 77/302 (25.5) | 114/305 (37.4)† | 11.9 (4.6 to 19.2) |
|
| |||
| Children with missing 2-yr data classified as not having had an event (intention-to-treat analysis)‡ | 39/302 (12.8) | 72/305 (25.4)§ | 12.6 (6.1 to 19.0) |
|
| |||
| Children with missing 2-yr data omitted | 39/264 (14.8) | 72/263 (27.4)§ | 12.6 (5.7 to 19.5) |
|
| |||
| Treatment failureঠ| 14/302 (5.0) | 27/305 (9.6)|| | 4.5 (0.2 to 8.8) |
|
| |||
| Renal scarring** | |||
|
| |||
| Overall | 27/227 (11.9) | 24/235 (10.2) | −1.7 (−7.4 to 4.0) |
|
| |||
| Severe†† | 9/227 (4.0) | 6/235 (2.6) | −1.4 (−4.7 to 1.8) |
|
| |||
| New‡‡ | 18/220 (8.2) | 19/227 (8.4) | 0.2 (−4.9 to 5.3) |
|
| |||
| Any cortical defect | 29/227 (12.8) | 25/235 (10.6) | −2.1 (−8.0 to 3.7) |
|
| |||
| Antimicrobial resistance | |||
|
| |||
| Resistant Escherichia coli in stool | 56/203 (27.6) | 41/210 (19.5) | −8.1 (−16.2 to 0.1) |
|
| |||
| First recurrent febrile or symptomatic UTI with resistant E. coli | 19/30 (63.3)§§ | 11/57 (19.3) | −44.0 (−64.1 to −24.0) |
|
| |||
| First recurrent febrile or symptomatic UTI with any resistant pathogen | 26/38 (68.4)§§ | 17/69 (24.6) | −43.8 (−61.7 to −25.8) |
Included are 7 children (3 in the trimethoprim–sulfamethoxazole group and 4 in the placebo group) with febrile or symptomatic UTIs that occurred before a missed 2-year visit. Imputation was applied to 38 children in the trimethoprim–sulfamethoxazole group and 42 children in the placebo group.
P = 0.002 by log-rank test stratified according to five core sites.
Percentages are based on Kaplan–Meier 2-year estimates.
P<0.001 by the log-rank test stratified according to five core sites.
Treatment failure was defined as the occurrence of two febrile UTIs (28 children), one febrile UTI and three symptomatic UTIs (2 children), four symptomatic UTIs (2 children), or new or worsening renal scarring (9 children).
P = 0.04 by the log-rank test stratified according to five core sites.
Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning.
Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by a diffusely scarred and shrunken kidney.
New renal scarring was defined as scarring on the outcome renal scan with technetium-99m–labeled dimercaptosuccinic acid that was not present at baseline.
P<0.001 by the Cochran–Mantel–Haenszel test stratified according to five core sites.