Introduction
Methods
Study design and participants
Intervention and randomization
Procedures
Outcomes
Statistical analysis
Original analysis plan
Bayesian analysis plan
Results
Patient characteristics
Variables | Total randomized patients (n= 48) | p | |
---|---|---|---|
Dexamethasone group n= 23 | Control group n= 25 | ||
Age in months | 9.4 (5.3–12.3) | 7.4 (3.7–13.7) | 0.768 |
Sex (females) | 15 (66%) | 14 (56%) | 0.514 |
Race (Caucasian) | 18 (78%) | 22 (88%) | 0.481 |
Urinary tract abnormalities on fetal US | 1 (4%) | 0 (0%) | 0.292 |
Max body temperature in °C | 39.5 (39.3–40.0) | 39.3 (38.8–39.8) | 0.019 |
Duration of fever in days | 2 (2-4) | 3 (2-4) | 0.218 |
Weight in kg | 8.5 (7.0–10.0) | 8.0 (6.6–10.0) | 0.943 |
Weight percentile by sex/age | 50.0 (25.0–90.0) | 75.0 (50.0–78.8) | 0.552 |
Height in cm | 70.0 (65.5–75.5) | 68.0 (65.0–75.0) | 0.752 |
Height percentile by sex/age | 75.0 (50.0–90.0) | 75.0 (50.0–90.0) | 0.772 |
PCT ng/ml | 2.8 (1.4–5.7) | 3.1 (1.7–8.1) | 0.677 |
CRP mg/L | 15.0 (9.2–75) | 17.0 (6.5–46.2) | 0.689 |
Leukocytes n/mm3 | 17.920 (12.930–23.800) | 18.580(14.782–24.555) | 0.488 |
Hemoglobin g/L | 11.1 (10.2–11.6) | 11.0 (10.2–11.5) | 0.783 |
Urea mg/dL | 13.0 (7.3–16.8) | 11.0 (8.0–16.0) | 0.756 |
Creatinine mg/dL | 0.32 (0.28–0.36) | 0.30 (0.28–0.40) | 0.850 |
Leukocyturia on urine dipstick | 23 (100%) | 24 (96%) | 0.332 |
Nitraturia on urine dipstick | 15 (65%) | 17 (68%) | 0.838 |
Urine method collection for culture | |||
•Catheterization | 22 (96%) | 21 (84%) | 0.305 |
•Clean catch | 1 (4%) | 4 (16%) | |
Hospitalization | 15 (65%) | 20 (80%) | 0.250 |
Urine culture positive | 20 (87%) | 22 (88%) | 0.772 |
Isolated germs on urine culture | |||
•E. coli | 20 (87%) | 22 (88%) | 0.772 |
•Other germ | 0 (0%) | 0 (0%) | |
Antibiotics initially administered | 0.282 | ||
•Oral | |||
°Amoxicillin-clavulanate | 11 (100%) | 9 (100%) | |
•Parenteral | |||
°Ceftriaxone | 11 (92%) | 13 (81%) | |
°Amoxicillin-clavulanate | 1 (8%) | 1 (4%) | |
°Ampicillin-sulbactam | 0 (0%) | 2 (8%) | |
Switch in antibiotics | 11 (48%) | 14 (56%) | 0.570 |
•Oral | 10 (43%) | 10 (40%) | |
°Amoxicillin-clavulanate | 6 (60%) | 6 (60%) | 0.410 |
°Cefixime | 3 (30%) | 2 (20%) | |
°Cefpodoxime | 0 (0%) | 1 (10%) | |
°Cefibutene | 0 (0%) | 1 (10%) | |
°Other | 1 (10%) | 0 (0%) | |
•Parenteral | 1 (4%) | 4 (16%) | |
°Ampicillin-sulbactam | 0 (0%) | 1 (25%) | |
°Ceftriaxone | 1 (100%) | 2 (50%) | 0.660 |
°Meropenem | 0 (0%) | 1 (25%) | |
Antibiotic therapy duration in days | 9 (9–10) | 10 (8.25–10) | 0.720 |
Kidney and bladder US performed | 18 (78%) | 21 (84%) | 1.000 |
Patients with abnormal findings | 9 (50%) | 4 (19%) | |
°Loss of cortico-medullary differentiation | 1 | 0 | 0.041 |
°Parenchymal thinning | 0 | 1 | |
°Calyceal dilatation | 4 | 3 | |
°Pelvic dilatation | 4 | 2 | |
°Uretheral dilatation | 2 | 1 | |
°Parenchymal hyperechogenicity | 1 | 0 | |
VCUG | 6 (30%) | 4 (18%) | 0.369 |
•VUR at MCUG | 1 * | 2 ** |
Variables | Total randomized patients (n= 18) | p | |
---|---|---|---|
Dexamethasone group n= 7 | Control group n= 11 | ||
Age in months | 10.7 (3.9–16.1) | 11.6 (5.1–18.2) | 0.964 |
Sex (females) | 3 (43%) | 7 (64%) | 0.630 |
Race (Caucasian) | 5 (71%) | 9 (82%) | 0.717 |
Urinary tract abnormalities on fetal US | 1 (14%) | 0 (0%) | 0.389 |
Max body temperature in °C | 39.5 (39.3–40.0) | 39.3 (38.3–39.8) | 0.099 |
Duration of fever in days | 2 (2–4) | 3 (2–4) | 0.376 |
Weight in kg | 7.7 (7.2–10.5) | 8.9 (6.5–11.0) | 0.856 |
Weight percentile by sex/age | 50.0 (25.0–90.0) | 75.0 (50.0–78.8) | 0.824 |
Height in cm | 68 (62.0–80.0) | 70.0 (62.0–80.0) | 0.892 |
Height percentile by sex/age | 50.0 (50.0–90.0) | 75.0 (50.0–90.0) | 0.852 |
PCT ng/ml | 3.6 (1.3–6.1) | 2.3 (1.7–3.3) | 0.526 |
CRP mg/L | 15.2 (10.0–115.1) | 17.0 (4.1–109) | 0.821 |
Leukocytes n/mm3 | 19.630 (7.020–29.150) | 18.480 (16.800–25.600) | 0.441 |
Hemoglobin g/L | 11.1 (10.2–11.7) | 11.0 (10.0–11.6) | 0.585 |
Urea mg/dL | 14.0 (12.0–35.9) | 11.0 (8.0–18.0) | 0.266 |
Creatinine mg/dL | 0.38 (0.33–0.50) | 0.29 (0.24–0.30) | 0.055 |
Leukocyturia on urine dipstick | 6 (86%) | 10 (91%) | 0.732 |
Nitraturia on urine dipstick | 6 (86%) | 9 (82%) | 0.829 |
Urine method collection for culture | |||
•Catheterization | 7 (100%) | 8 (73%) | 0.130 |
•Clean catch | 0 (0%) | 3 (27%) | |
Hospitalization | 4 (57%) | 9 (82%) | 0.255 |
Antibiotics initially administered | 0.464 | ||
•Oral | |||
°Amoxicillin-clavulanate | 4 (57%) | 3 (27%) | |
•Parenteral | |||
°Ceftriaxone | 3 (43%) | 7 (64%) | |
°Ampicillin-sulbactam | 0 (0%) | 1 (9%) | |
Switch in antibiotics | 3 (43%) | 7 (64%) | 1.000 |
•Oral | |||
°Amoxicillin-clavulanate °Cefixime | 1 2 | 4 1 | |
°Cefibutene | 0 | 1 | |
•Parenteral | |||
°Meropenem | 0 (0%) | 1 (9%) | |
Antibiotic therapy duration in days | 10 (9–10) | 10 (8–15) | 0.771 |
Kidney and bladder US performed | 5 (71%) | 11 (100%) | |
Abnormal kidney and bladder US | 4 (57%) | 3 (27%) | 0.627 |
°Parenchymal thinning | 0 (0%) | 1 (9%) | |
°Calyceal dilatation | 2 (28%) | 2 (18%) | |
°Pelvic dilatation | 1 (14%) | 2 (18%) | |
°Uretheric dilatation | 1 (14%) | 1 (9%) | |
VCUG | 3 (43%) | 2 (18%) | 0.326 |
•VUR at VCUG | 1 * | 1 ** |
Primary outcome
Treatment (n=7) | Control (n=11) | ||||
---|---|---|---|---|---|
0% (0) | 18% (2) | ||||
Predictive posterior estimates (95% credible interval) | πTreat − πControl (95% credible interval) | P(πtreat − πcontrol < 0) | P(πtreat − πcontrol < − 0.2) | ||
Informative | 1 (0 ; 4) | 4 (1 ; 7) | −0.19 (−0.29 ; −0.06) | 0.99 | 0.39 |
Low-informative | 0 (0 ; 3) | 3 (0 ; 7) | −0.20 (−0.33 ; −0.03) | 0.98 | 0.47 |
Uninformative | 1 (0 ; 4) | 3 (0 ; 7) | −0.09 (−0.40 ; 0.25) | 0.70 | 0.25 |