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CompletedNCT07229755Updated Nov 17, 2025

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

A Phase 2/3 interventional study of Ceftriaxone (Rocephin®) and Levofloxacin in Urinary Tract Infection (Diagnosis), sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Ain Shams University · Phase 2/3, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jul 2024, registered Nov 2025).
Phase
Phase 2/3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
4 Years to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Urinary Tract Infection (Diagnosis)
03

In context

Urinary Tract Infections

753 studies on the registry are indexed under Urinary Tract Infections; 127 are open to participants now.

This study's enrollment of 140 is close to the median of 130 across 523 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
140 participants (actual)

Study arms

  • Placebo comparator
    empirical antibiotic prophylaxis

    empirical antibiotic not culture guided

    Drug: Ceftriaxone (Rocephin®) · Device: Levofloxacin

  • Experimental
    enhanced antibiotic prophylaxis

    Drug: Ceftriaxone (Rocephin®) · Device: Levofloxacin

Interventions

  • DrugCeftriaxone (Rocephin®)

    empirical antibiotic vs urine culture guided antibiotic

  • DeviceLevofloxacin

    culture based antibiotic

06

What researchers measure

Primary outcomes

  1. Decreased rate of urinary tract infection after Flexible ureteroscopy in Children

    Time frame: From enrollment to the end of treatment at 2 weeks

07

Study locations

1 site
  • Ain Shams University
    Cairo, Egypt
08

References and documents

Publications

  • 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. PubMed 38398427 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07229755
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Jul 1, 2024
Primary completion
Dec 31, 2024
Completion
Feb 5, 2025
Last update
Nov 17, 2025

Study contacts

Diaa El din Mahmoud, Proffessor
study director · Ain Shams University
Mohamed Saied, Lecturer
study director · Ain Shams University
Hisham Arafa
study director · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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