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. 2015 Jan-Feb;20(1):45–47. doi: 10.1093/pch/20.1.45

TABLE 1.

Incidence of recurrent urinary tract infections (UTIs) in the three largest published trials of antibiotic prophylaxis

Study Age of children enrolled Inclusion criteria UTI definition Intervention Sample size Patients with UTIs Relative risk of UTI in group on prophylaxis NNTP
All patients* Prophylaxis group* Control group*
Montini et al (8), 2008; Italy 2 months to 7 years One febrile UTI; excluded if the child had a complex urological malformation or severe renal damage Fever AND either elevated ESR/CRP or elevated neutrophil count AND 2 urines with: pyuria AND ≥108/Lof a singleorganism TMP-SMX or amoxicillin-clavulanate† 211 cases; 127 controls 27/312 (8.7%)
Subgroups:

  • No VUR: 8/210 (3.8%)

  • Grade I or II VUR: 7/88 (4.3%)

  • Grade III VUR: 12/40 (30%)

 15/211 (7 1%)
Subgroups:

  • No VUR: 5/129 (3.9%)

  • Grade I or II VUR: 4/56 (7.1%)

  • Grade III VUR: 6/26 (23.1%)

 12/127 (9.5%)
Subgroups:

  • No VUR: 3/81 (3.7%)

  • Grade I or II VUR: 3/32 (9.4%)

  • Grade III VUR: 6/14 (42 9%)

 0 75 (95% CI 0.36–1.55; P=0.44) 42
PRIVENT (9), 2009; Australia Birth to 18 years One or more symptomatic UTIs at any time in the past; excluded if the child had a urological predisposing cause UTI symptoms (not defined) AND positive urine culture‡ TMP-SMX (controls received TMP-SMX for only the first 14 days) 288 cases; 288 controls 91/576 (16%) 36/288 (13%) Subgroup: febrile recurrences 19/288 (7%) 55/288 (19) Subgroup: febrile recurrences 36/288 (13%) 0.65 (95% CI 0.44–0.96; P=0.03) 17
RIVUR (11), 2014; United States 2 to 71 months One or two UTIs within the last 112 days with grade I – IV VUR and no urological anomalies Pyuria, positive urine culture§, AND fever or urinary symptoms TMP-SMX 302 cases; 305 controls 111/607 (18.2%)
Grade I or II VUR: 46/322 (14.3%)
Grade III or IV VUR: 64/280 (22.9%)		 39/302 (12.9%) 72/305 (23.6%) 0.55 (95% CI 0.38–0.78) 9

CRP C-reactive protein; ESR Erythrocyte sedimentation rate; NNTP Number of children needed to treat to prevent one UTI during study follow-up (one year in the Montini et al(8) and PRIVENT(9) studies and two years in the RIVUR(11) study; TMP-SMX Trimethoprim-sulfamethoxazole (also known as cotrimoxazole); VUR Vesicoureteral reflux.

*

Results assume that patients lost to follow-up did not experience recurrences because this is the only analysis reported in the PRIVENT study;

†

The original plan was to compare the two antibiotics; however, recruitment was slow and this plan was abandoned. Both antibiotics were dosed at 15 mg/kg/day, presumably of the TMP component for the TMP-SMX;

‡

Any growth from a suprapubic aspiration urine specimen, ≥107/L of a single organism from a catheter sample or ≥108/L of a single organism for clean voided specimens;

§

Single organism that was neither Lactobacillus nor Candida, at ≥5×107/L for catheterized or suprapubic aspiration urine specimens or ≥108/L for clean voided specimens;

Suprapubic, abdominal or flank pain or tenderness; urinary urgency, frequency or hesitancy; dysuria; foul-smelling urine; or, in infants younger than 4 months of age, failure to thrive, dehydration or hypothermia