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

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07355907
Enrollment
210
Registered
2026-01-21
Start date
2023-01-01
Completion date
2025-01-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calculi, Renal, PCNL, Infectious Complications

Keywords

renal stones, PCNL, INFECTION, SEPSIS, ANTIBIOTIC PROPHYLAXIS

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.

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.

Interventions

PROCEDUREPCNL

PCNL for renal stones

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* adult patients with renal stones scheduled for PCNL

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
post-operative infectious complications and sepsis1 week

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026