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A clinical trial to study the effectiveness of low dose antibiotic treatment and placebo for prevention of urinary infection in children with vesicoureteric reflux

Antibiotic Prophylaxis in the Management of Vesicoureteric Reflux: A Randomized Double-Blind Placebo Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/02/002462
Enrollment
192
Registered
2012-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Urinary tract infections in vesicoureteric reflux patients

Interventions

Intervention1: Co-trimoxazole: 2mg/kg body weightdailky in a single dose Control Intervention1: placebo: 2mg/kg/day as single dose at night

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children between 1-14 years of age and of either sex who are diagnosed to have primary VUR on micturating cystourethrogram will be recruited.

Exclusion criteria

Exclusion criteria: 1. Patients below 1 year of age 2. Patients with unilateral or bilateral severe(grade V) 3. VUR secondary to urinary tract obstruction including posterior urethral valves, neurogenic bladder and primary megaureter 4. Patients with symptoms of voiding dysfunction 5. Patients with history of drug sensitivity to sulphonamide 6. Immunocompromised patients or those receiving prophylactic cotrimoxazole for other reasons 7. S.Creatinine > 1.5 mg/dl

Design outcomes

Primary

MeasureTime frame
1.Number of episodes of urinary tract infection 2.2. Treatment failure Patients developing more than 2 episodes of UTI in 6 months during the follow-up will be considered as treatment failures. Timepoint: 1.From baseline(0) to 1 year 2.From baseline(0) to 6 months

Secondary

MeasureTime frame
1.Asymptomatic bactriuria 2.Side effects 3.ComplianceTimepoint: Every month from baseline(0) to 1year

Countries

India

Contacts

Public ContactDr Pankaj Hari

AIIMS

pankajhari@hotmail.com011-26594858

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026