Does periprocedural antibiotic prevent micturating cystourethrography (MCU) associated urinary tract infection in children?

Periprocedural antibiotic prophylaxis compared to placebo in preventing voiding cystourethrography-associated urinary tract infection in children- A randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079750

Enrollment

208

Registered

2025-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: Peri-procedural Antibiotics (Co- trimoxazole): one randomized group of patients undergoing voiding cystourethrography receiving antibiotic Co-trimoxazole at 2 mg/Kg (Syrup Bactrim (40 m

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 3 months to 18 years undergoing voiding cystourethrography

Exclusion criteria

Exclusion criteria: 1) Children on immunosuppressive medications like nephrotic syndrome or post kidney transplant recipients 2) Children with known allergy to cotrimoxazole/ radiocontrast agent or sulpha allergy 3) Patient who already has an indwelling urinary catheter on the day of voiding cystourethrography 4) Child having fever and/or signs and symptoms of urinary tract infection on the scheduled day of voiding cystourethrography

Design outcomes

Primary

Measure	Time frame
To compare the proportion of patients who develop symptomatic voiding cystourethrography-associated urinary tract infection within 7 days post procedure between the antibiotic prophylaxis group and placebo group in children aged 3 months to 18 years undergoing voiding cystourethrographyTimepoint: Within 7 days post voiding cystourethrography	—

Secondary

Measure	Time frame
To compare the proportion of patients who have asymptomatic bacteriuria between days 2-7 post voiding cystourethrography in the antibiotic prophylaxis and placebo groups. To compare the proportion of patients who develop symptomatic voiding cystourethrography-associated urinary tract infection between 7-14 days post procedure between the antibiotic prophylaxis group and placebo group To determine the antibiotic sensitivity pattern in these children. To identify the risk factors for developing post-voiding cystourethrography-associated urinary tract infection.Timepoint: 2-14 days post voiding cystourethrography	—

Measure

Time frame

To compare the proportion of patients who have asymptomatic bacteriuria between days 2-7 post voiding cystourethrography in the antibiotic prophylaxis and placebo groups. To compare the proportion of patients who develop symptomatic voiding cystourethrography-associated urinary tract infection between 7-14 days post procedure between the antibiotic prophylaxis group and placebo group To determine the antibiotic sensitivity pattern in these children. To identify the risk factors for developing post-voiding cystourethrography-associated urinary tract infection.Timepoint: 2-14 days post voiding cystourethrography

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Countries

India

Contacts

Public ContactDr Sudarsan K

Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER)

sudarsanjipmer@gmail.com9855071507

Outcome results

None listed

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