Without antibiotic prophylaxis in children with mild vesicoureteral reflux (grade 0-2) after a first urinary tract infection. : A multicenter trial.

UMIN ID: UMIN000001806

Registered date:27/03/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Urinary tract infection
• Date of first enrollment: 2008/12/01
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Non-administration of antibiotics.

Outcome(s)

• Primary Outcome: Relapse free survival of upper urinary tract infection.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 1months-old
• Age maximum: 48months-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Tokyo Metropolitan Children's Medical Center
• Source(s) of Monetary Support: Clinical research of Tokyo metropolitan hospital group