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

January 12, 2026 updated by: Ahmed Zoeir, Tanta University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 11511
        • Faculty of medicine, Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult patients with renal stones scheduled for PCNL

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Preoperative Fosfomycin Trometamol group
Fosfomycin before PCNL
Procedure: PCNL
PCNL for renal stones
Active Comparator: Preoperative 5-day Levofloxacin group
Levofloxacin before PCNL
Procedure: PCNL
PCNL for renal stones
Other: No preopertive antibiotic group
control, no preoperative antibiotic before PCNL
Procedure: PCNL
PCNL for renal stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
post-operative infectious complications and sepsis
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

July 2, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35524/6/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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