Calculi, RenalNCT07355907
Preoperative Prophylactic Fosfomycin Trometamol Versus 5-day Levofloxacin in Prevention of Postpercutaneous Nephrolithotomy Infectious Complications and Sepsis.
A study testing PCNL in people with Calculi, Renal and PCNL, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Calculi, Renal, PCNL, Infectious Complications
- What is being tested?
- PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult patients with renal stones scheduled for PCNL
Who cannot join
- Unfit patients for surgery
- patients with active UT
- uncorrected coagulopathy
- pregnancy
- children
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Calculi, Renal, PCNL, Infectious Complications
- Being tested
- PCNL
- Keywords
- renal stones, PCNL, INFECTION, SEPSIS, ANTIBIOTIC PROPHYLAXIS
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNLProcedure or surgery
PCNL for renal stones
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Fosfomycin Trometamol group | Active comparator | Fosfomycin before PCNL Receives: Procedure: PCNL |
| Preoperative 5-day Levofloxacin group | Active comparator | Levofloxacin before PCNL Receives: Procedure: PCNL |
| No preopertive antibiotic group | Other | control, no preoperative antibiotic before PCNL Receives: Procedure: PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative infectious complications and sepsis
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jan 2023
- Primary completion2 Jul 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculi, RenalStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zoeir, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355907
- Sponsor's protocol ID
- 35524/6/22
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07355907
- Acronym / sponsor ID
- 35524/6/22
- Conditions
- Calculi, Renal, PCNL, Infectious Complications
- Keywords
- renal stones, PCNL, INFECTION, SEPSIS, ANTIBIOTIC PROPHYLAXIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preoperative Fosfomycin Trometamol group | Active comparator | Procedure: PCNLFosfomycin before PCNL |
| Preoperative 5-day Levofloxacin group | Active comparator | Procedure: PCNLLevofloxacin before PCNL |
| No preopertive antibiotic group | Other | Procedure: PCNLcontrol, no preoperative antibiotic before PCNL |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with renal stones scheduled for PCNL
Key exclusion criteria (5 listed)
- Unfit patients for surgery
- patients with active UT
- uncorrected coagulopathy
- pregnancy
- children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCNLPCNL for renal stones | Procedure or surgery | No preopertive antibiotic group, Preoperative 5-day Levofloxacin group, Preoperative Fosfomycin Trometamol group |
Primary outcome
post-operative infectious complications and sepsis
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCNL in people with Calculi, Renal and PCNL, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative infectious complications and sepsis (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.