NCT07355907

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

Calculi, RenalPCNLInfectious Complications

Keywords

renal stonesPCNLINFECTIONSEPSISANTIBIOTIC PROPHYLAXIS

Outcome Measures

Primary Outcomes (1)

  • post-operative infectious complications and sepsis

    1 week

Study Arms (3)

Preoperative Fosfomycin Trometamol group

ACTIVE COMPARATOR

Fosfomycin before PCNL

Procedure: PCNL

Preoperative 5-day Levofloxacin group

ACTIVE COMPARATOR

Levofloxacin before PCNL

Procedure: PCNL

No preopertive antibiotic group

OTHER

control, no preoperative antibiotic before PCNL

Procedure: PCNL

Interventions

PCNLPROCEDURE

PCNL for renal stones

No preopertive antibiotic groupPreoperative 5-day Levofloxacin groupPreoperative Fosfomycin Trometamol group

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients with renal stones scheduled for PCNL

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Tanta University

Tanta, 11511, Egypt

Location

MeSH Terms

Conditions

Kidney CalculiNephrolithiasisInfectionsSepsis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tanta, ElGeish street, Gharbiya government, Egypt

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

January 1, 2023

Primary Completion

July 2, 2024

Study Completion

January 1, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

EG(1)