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Completed

NCT Number: NCT07355907

Preoperative Prophylactic Fosfomycin Trometamol Versus 5-day Levofloxacin in Prevention of Postpercutaneous Nephrolithotomy Infectious Complications and Sepsis.

A randomized controlled trial comparing the use of preoperative prophylactic single dose fosfomycin trometamol versus levofloxacin in prevention of post-PCNL infectious complications and sepsis.

the 3 groups were compared as regards the baseline data, preoperative data, intra-operative data, and post-op data.

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Key information

About this study

A prospective randomized study, in which 300 patients admitted to urology department, Tanta university with renal stones prepared for PCNL were randomly distributed into 3 groups:

Group I, included 70 patients received single oral dose Fosfomycin 3 gm the night before the procedure.

Group II, included 70 patients received 5 days levofloxacin 500 mg once daily before PCNL Group III, included 70 patients will not receive preoperative treatment

The patients were evaluated by: complete hemogram, renal function, stone work-up, and MSU culture were done preoperatively.

NCCT was done for all included patients Intraoperative renal pelvic urine (collected after ureteral catheterization or at first puncture of pelvicalyceal system [PCS]) and stone fragments were collected in sterile plastic containers for culture. The samples were sent immediately (within 1 hour) to the laboratory for processing.

The following data were recorded and compared; patients' demographic data, stone characteristics, preoperative lab. Investigations, intraoperative data (OR time and complications) and postoperative data (SFR, complications especially infectious ones, sepsis and fever, hospital stay), and post-operative bacteruria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients with renal stones scheduled for PCNL

Exclusion criteria

  • Unfit patients for surgery
  • patients with active UT
  • uncorrected coagulopathy
  • pregnancy
  • children

Treatment and study plan

PCNL

Procedure

PCNL for renal stones

Primary outcomes

  1. post-operative infectious complications and sepsis

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison of Preoperative Prophylactic Single Dose Fosfomycin Trometamol Versus 5-day Levofloxacin in Prevention of Post-percutaneous Nephrolithotomy Infectious Complications and Sepsis: A Prospective Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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