NephrolithiasisNCT04374188
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy
A study testing Ciprofloxacin and Levofloxacin in people with Nephrolithiasis, run by Diaa Eldin Taha Ramadan Mohamed at 1 site in Egypt.
Trial summary
Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Ciprofloxacin and Levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patient 18 years or older
- Stones ≥ 2 cm and/or mild to moderate hydronephrosis
- Sterile mid urine stream
Who cannot join
- Patients with a stent, nephrostomy tube or indwelling catheter
- Renal failure
- Fever before surgery
- Previous manipulation/procedure
- Concomitant bladder stone or tumour
- Patients with active UTI
- Contralateral renal/ureteric stone
Trial locations and contacts
1 site in 1 country.
Hossam Nabeeh, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh faculty of medicine
Kafr ash Shaykh, Kafrelsheikh
Diaa ELDIN Taha, MD, 01008531384, drdiaaeldin@gmail.com
Hossam Nabeeh, MD
About this study
Official title: Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial
Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.
Read the detailed description
To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.
- Conditions
- Nephrolithiasis
- Being tested
- Ciprofloxacin, Levofloxacin
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Also called quinolones
drug adminstration to ameliorate sepsis incidence
LevofloxacinDrug
Also called quinolones
levofloxacin pill
| Study group | Role | What they receive |
|---|---|---|
| ciprofloxacin | Active comparator | ciprofloxacin tablets Receives: Drug: Ciprofloxacin |
| levofloxacin | Active comparator | levofloxacin tablets Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ciprofloxacin versus levofloxacin duration before PCNL
To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL.
Measured: 12 months
Secondary outcomes (2)
differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine
Compare the difference between C\&S of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone, in predicting the upper urinary tract infection and urosepsis.
Measured: 12 months
predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.
assess the risk factors for SIRS and sepsis in PCNL.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Sep 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- 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
- Model description
- Efficacy of ciprofloxacin therapy in sepsis avoidance.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diaa Eldin Taha Ramadan Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diaa Eldin Taha Ramadan Mohamed, Kafrelsheikh University
- Investigators
- Diaa Eldin Taha, MD, Principal investigator, Lecturer of urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374188
- Sponsor's protocol ID
- RS/19.23
- Status last verified
- Mar 2021
- First submitted
- 18 Apr 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04374188
- Acronym / sponsor ID
- RS/19.23
- Conditions
- Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Diaa Eldin Taha Ramadan MohamedUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 5 May 2020 (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.
Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.
Detailed description
To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Efficacy of ciprofloxacin therapy in sepsis avoidance.
| Arm | Type | Receives |
|---|---|---|
| ciprofloxacin | Active comparator | Drug: Ciprofloxacinciprofloxacin tablets |
| levofloxacin | Active comparator | Drug: Levofloxacinlevofloxacin tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Patient 18 years or older
- Stones ≥ 2 cm and/or mild to moderate hydronephrosis
- Sterile mid urine stream
Key exclusion criteria (7 listed)
- Patients with a stent, nephrostomy tube or indwelling catheter
- Renal failure
- Fever before surgery
- Previous manipulation/procedure
- Concomitant bladder stone or tumour
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 |
|---|---|---|
| CiprofloxacinAlso: quinolonesdrug adminstration to ameliorate sepsis incidence | Drug | ciprofloxacin |
| LevofloxacinAlso: quinoloneslevofloxacin pill | Drug | levofloxacin |
Primary outcome
Effect of ciprofloxacin versus levofloxacin duration before PCNL
Time frame: 12 months
To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL.
2 secondary outcomes
differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine
Time frame: 12 months
predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Hossam Nabeeh, MD contact
Diaa Eldin Taha, MD principal investigator
Lecturer of urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofloxacin and Levofloxacin in people with Nephrolithiasis, run by Diaa Eldin Taha Ramadan Mohamed 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diaa Eldin Taha, MD (01008531384, drdiaaeldin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of ciprofloxacin versus levofloxacin duration before PCNL (time frame: 12 months). 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 3 Mar 2021; AzTrials last refreshed its copy on 9 Nov 2026.