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

NCT07229755 | Completed Phase 2 DMC

• 1 other identifier: FMASU MS591/2024
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infection (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Decreased rate of urinary tract infection after Flexible ureteroscopy in Children

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

empirical antibiotic prophylaxis

PLACEBO COMPARATOR

empirical antibiotic not culture guided

Drug: Ceftriaxone (Rocephin®); Device: Levofloxacin

enhanced antibiotic prophylaxis

EXPERIMENTAL

Drug: Ceftriaxone (Rocephin®); Device: Levofloxacin

Interventions

Ceftriaxone (Rocephin®) DRUG

empirical antibiotic vs urine culture guided antibiotic

empirical antibiotic prophylaxis; enhanced antibiotic prophylaxis

Levofloxacin DEVICE

culture based antibiotic

empirical antibiotic prophylaxis; enhanced antibiotic prophylaxis

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

• Akram M, Jahrreiss V, Skolarikos A, Geraghty R, Tzelves L, Emilliani E, Davis NF, Somani BK. Urological Guidelines for Kidney Stones: Overview and Comprehensive Update. J Clin Med. 2024 Feb 16;13(4):1114. doi: 10.3390/jcm13041114.

  PMID: 38398427 RESULT

MeSH Terms

Conditions

Urinary Tract Infections; Disease

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Diaa El din Mahmoud, Proffessor

  Ain Shams University

  STUDY DIRECTOR

• Mohamed Saied, Lecturer

  Ain Shams University

  STUDY DIRECTOR

• Hisham Arafa

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 5, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)