Urinary Tract Infection (Diagnosis)Phase 2/3NCT07229755
Comparison Between Effect of Empirical Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy in Children With Pyuria
A Phase 2/3 study testing Ceftriaxone (Rocephin®) and Levofloxacin in people with Urinary Tract Infection (Diagnosis), run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between effect of empirical antibiotic prophylaxis versus enhanced prophylactic measures on rate of urinary tract infection after Flexible ureteroscopy in Children. Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection (Diagnosis)
- What is being tested?
- Ceftriaxone (Rocephin®) and Levofloxacin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 5 Feb 2025
- Phase
- Phase 2/3
- 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 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age starting from 4 up to 14 years old.
- Patients with renal stones from 1cm to 1.5cm in largest dimensions (not more than 4 cm3 measured by CTUT) undergoing flexible URS.
Who cannot join
- Patients who refuse to participate in the study.
- Patients with single functioning kidney.
- Patients with rising serum creatinine.
- Known patient with neurogenic bladder.
- Patients with DM type1.
- Immunocompromised children.
- Children with coagulopathy.
- Patients with untreated UTI (or any interfering symptoms with UTI as fever or irritative LUTS).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare between effect of empirical antibiotic prophylaxis versus enhanced prophylactic measures on rate of urinary tract infection after Flexible ureteroscopy in Children.
- Conditions
- Urinary Tract Infection (Diagnosis)
- Being tested
- Ceftriaxone (Rocephin®), Levofloxacin
- Medical subject headings
- Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone (Rocephin®)Drug
empirical antibiotic vs urine culture guided antibiotic
LevofloxacinDevice
culture based antibiotic
| Study group | Role | What they receive |
|---|---|---|
| empirical antibiotic prophylaxis | Placebo comparator | empirical antibiotic not culture guided Receives: Drug: Ceftriaxone (Rocephin®); Device: Levofloxacin |
| enhanced antibiotic prophylaxis | Experimental | Not described Receives: Drug: Ceftriaxone (Rocephin®); Device: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased rate of urinary tract infection after Flexible ureteroscopy in Children
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2024
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diaa El din Mahmoud, Proffessor, Study director, Ain Shams UniversityMohamed Saied, Lecturer, Study director, Ain Shams UniversityHisham Arafa, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229755
- Sponsor's protocol ID
- FMASU MS591/2024
- Status last verified
- Jun 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Akram M, Jahrreiss V, Skolarikos A, Geraghty R, Tzelves L, Emilliani E, Davis NF, Somani BK. Urological Guidelines for Kidney Stones: Overview and Comprehensive Update. J Clin Med. 2024 Feb 16;13(4):1114. doi: 10.3390/jcm13041114.
PubMed 38398427
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Effect of Empirical Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy in Children With Pyuria
- ClinicalTrials.gov ID
- NCT07229755
- Acronym / sponsor ID
- FMASU MS591/2024
- Conditions
- Urinary Tract Infection (Diagnosis)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 17 Nov 2025 (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.
The aim of this study is to compare between effect of empirical antibiotic prophylaxis versus enhanced prophylactic measures on rate of urinary tract infection after Flexible ureteroscopy in Children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empirical antibiotic prophylaxis | Placebo comparator | Drug: Ceftriaxone (Rocephin®), Device: Levofloxacinempirical antibiotic not culture guided |
| enhanced antibiotic prophylaxis | Experimental | Drug: Ceftriaxone (Rocephin®), Device: Levofloxacin |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age starting from 4 up to 14 years old.
- Patients with renal stones from 1cm to 1.5cm in largest dimensions (not more than 4 cm3 measured by CTUT) undergoing flexible URS.
Key exclusion criteria (8 listed)
- Patients who refuse to participate in the study.
- Patients with single functioning kidney.
- Patients with rising serum creatinine.
- Known patient with neurogenic bladder.
- Patients with DM type1.
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 |
|---|---|---|
| Ceftriaxone (Rocephin®)empirical antibiotic vs urine culture guided antibiotic | Drug | empirical antibiotic prophylaxis, enhanced antibiotic prophylaxis |
| Levofloxacinculture based antibiotic | Device | empirical antibiotic prophylaxis, enhanced antibiotic prophylaxis |
Primary outcome
Decreased rate of urinary tract infection after Flexible ureteroscopy in Children
Time frame: From enrollment to the end of treatment at 2 weeks
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 17 Nov 2025.
- Results publication: PubMed 38398427Akram M, Jahrreiss V, Skolarikos A, Geraghty R, Tzelves L, Emilliani E, Davis NF, Somani BK. Urological Guidelines for Kidney Stones: Overview and Comprehensive Update. J Clin Med. 2024 Feb 16;13(4):1114. doi: 10.3390/jcm13041114.
- Individual participant dataSharing planned: Yes
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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.
Diaa El din Mahmoud, Proffessor study director
Ain Shams University
Mohamed Saied, Lecturer study director
Ain Shams University
Hisham Arafa study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ceftriaxone (Rocephin®) and Levofloxacin in people with Urinary Tract Infection (Diagnosis), run by Ain Shams 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 2 inclusion and 8 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 17 Nov 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decreased rate of urinary tract infection after Flexible ureteroscopy in Children (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229755, which also lists 1 linked publication.
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 17 Nov 2025.