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

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Urinary Tract Infection (Diagnosis)

Treatments: Device: Levofloxacin; Drug: Ceftriaxone (Rocephin®)

Study type: Interventional

Funder types: Other

Identifiers

NCT07229755

FMASU MS591/2024

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

empirical antibiotic prophylaxis

Placebo Comparator group

Description:

empirical antibiotic not culture guided

Treatment:

Drug: Ceftriaxone (Rocephin®)

Device: Levofloxacin

enhanced antibiotic prophylaxis

Experimental group

Treatment:

Drug: Ceftriaxone (Rocephin®)

Device: Levofloxacin