Condition 1: Vesicoureteral Reflux. Condition 2: Recurrent Urinary Tract Infection. Vesicoureteral-reflux Urinary tract infection, site not specified
Conditions
Interventions
Intervention 1: Intervention group 1: Continuous daily cephalexin prophylaxis at a dose of 15 milligrams per kilogram body weight administered orally once daily for 6 months. The medication will be pr
Sponsors
Ardabil University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children with primary VUR of any grade Children with primary VUR of any grade with recurrent urinary tract infections Children with primary VUR of any grade with bladder and bowel dysfunction
Exclusion criteria
Exclusion criteria: Children with secondary VUR Children with VUR of any grade without recurrent urinary tract infections or bladder and bowel dysfunction Children with primary VUR who underwent anti-reflux surgery and deflux treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive urine culture. Timepoint: Baseline before treatment initiation, during symptomatic episodes throughout the 6-month treatment period, and at the end of the 6-month treatment period. Method of measurement: Standard urine culture with bacterial count greater than 100000 colony forming units per milliliter.;Presence of pyuria in urinalysis. Timepoint: Baseline before treatment initiation, during symptomatic episodes throughout the 6-month treatment period, and at the end of the 6-month treatment period. Method of measurement: Microscopic urinalysis showing white blood cells greater than 5 per high power field.;Fever episodes. Timepoint: Continuous monitoring throughout the 6-month treatment period. Method of measurement: Axillary temperature measurement above 38 degrees Celsius.;Urinary frequency symptoms. Timepoint: Continuous monitoring throughout the 6-month treatment period. Method of measurement: Clinical assessment of urination frequency of at least three consecutive times with intervals less than ten minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibiotic resistance patterns. Timepoint: At baseline before treatment initiation and at the end of each 6-month treatment period. Method of measurement: Standard antibiotic susceptibility testing using disk diffusion method according to Clinical and Laboratory Standards Institute guidelines.;Adverse drug reactions. Timepoint: Continuous monitoring throughout each 6-month treatment period. Method of measurement: Clinical assessment and parental reporting of gastrointestinal symptoms, allergic reactions, and other drug-related adverse events. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoya Houshmandi Khaneghahi
Ardabil University of Medical Sciences
Outcome results
None listed