Urinary tract infection
Conditions
Interventions
Non-administration of antibiotics.
Sponsors
Tokyo Metropolitan Children's Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed first episode of UTI 8 weeks before registration. First episode of UTI 1. Body temperature >= 38.0 degrees C. 2. Positive results of urine culture by single strain (>= 10000 CFU/ml by bladder catheterization or >= 1000 CFU/ml by bladder aspiration). 2) The presence of VUR grade 0-2, monolateral or bilateral, diagnosed 2 weeks before registration. 3) Ages at the time of diagnosis of UTI are 1 months to < 4 years. 4) Written informed consent from the patients' parents or legal guardians.
Exclusion criteria
Exclusion criteria: 1) Gestational age < 37 weeks. 2) Weight at birth < 2000g. 3) Complex urologic malformations. 4) Neurogenic bladder. 5) Hydronephrosis or ureteral dilation over grade 3 according to SFU classification. 6) Phimosis and ballooning at urination. 7) Previous episode of UTI. 8) Using antibiotic prophylaxis for another infection. 9) Renal dysfunction at recovery phase of UTI. (By EIA method, <1year old: sCr >= 0.4, >=1year old: sCr >= 0.5) 10) Hypertension at recovery phase of UTI. 11) Liver dysfunction at recovery phase of UTI. (AST or ALT exceed over 2.5 times the upper limit of normal). 12) Known to be immunocompromised status. 13) Intractable UTI (duration of fever >= 7days after beginning of antibiotics). 14) Complicated septic shock or DIC. 15) Judged inappropriate for this study by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse free survival of upper urinary tract infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival of asymptomatic bacteriuria or cystitis. Incidence of renal scars with DMSA renal scintigraphy. Rate of non recurrence of upper urinary tract infection. Development rate of renal dysfunction. | — |
Countries
Japan
Contacts
Public ContactRiku Hamada
Tokyo Metropolitan Children's Medical Center Deparment of nephrology
Outcome results
None listed