Comparison Between Effect of Empirical Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy in Children With Pyuria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-02-05

Brief Summary

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The aim of this study is to compare between effect of empirical antibiotic prophylaxis versus enhanced prophylactic measures on rate of urinary tract infection after Flexible ureteroscopy in Children.

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Detailed Description

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Conditions

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Urinary Tract Infection (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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empirical antibiotic prophylaxis

empirical antibiotic not culture guided

Group Type PLACEBO_COMPARATOR

Ceftriaxone (Rocephin®)

Intervention Type DRUG

empirical antibiotic vs urine culture guided antibiotic

Levofloxacin

Intervention Type DEVICE

culture based antibiotic

enhanced antibiotic prophylaxis

Group Type EXPERIMENTAL

Ceftriaxone (Rocephin®)

Intervention Type DRUG

empirical antibiotic vs urine culture guided antibiotic

Levofloxacin

Intervention Type DEVICE

culture based antibiotic

Interventions

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Ceftriaxone (Rocephin®)

empirical antibiotic vs urine culture guided antibiotic

Intervention Type DRUG

Levofloxacin

culture based antibiotic

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age starting from 4 up to 14 years old.
* Patients with renal stones from 1cm to 1.5cm in largest dimensions (not more than 4 cm3 measured by CTUT) undergoing flexible URS.

Exclusion Criteria

* Patients who refuse to participate in the study.
* Patients with single functioning kidney.
* Patients with rising serum creatinine.
* Known patient with neurogenic bladder.
* Patients with DM type1.
* Immunocompromised children.

* Children with coagulopathy.
* Patients with untreated UTI (or any interfering symptoms with UTI as fever or irritative LUTS).

Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes