Percutaneous NephrolithotomyNCT03178292
Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy
A study testing Levofloxacin in people with Percutaneous Nephrolithotomy and Infection, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in reducing upper urinary tract infection and urosepsis after PCNL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Nephrolithotomy, Infection, Sepsis
- What is being tested?
- Levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2017to 15 Jun 2017
- 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
- Stones ≥ 2.5 cm and/or hydronephrosis
- Sterile mid urine stream
Who cannot join
- Patients with a stent, nephrostomy tube or indwelling catheter
- Uncontrolled Diabetes mellitus
- Renal failure
- Fever before surgery
- Concomitant bladder stone or tumour
- Patients with active UTI
- Contralateral renal/ureteric stone
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and Nephrology Center
Al Mansurah, Aldakahlia, 35516
Abdelwahab R. Hashem, Msc, 01069678979 ext. 002, abdelwahab_hashem@yahoo.com
About this study
Official title: Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy (PCNL)
To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in reducing upper urinary tract infection and urosepsis after PCNL.
Read the detailed description
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for removal of large volume upper urinary tract stones. Although PCNL is effective and yielding high stone-free rates, complications rates range from 18.30% to 83% with sepsis has been reported in 0.3% to 7.6% of cases result in the most common cause of perioperative mortality in PCNL patients.
Urosepsis after PNL is an important and potentially catastrophic complication. The overall incidence of fever (25%), bacteremia (23%), endotoxemia (34%) and septicemic shock occurs in 0.3%-2.5% of patients. Urosepsis and shock result from the intravasation of bacteria or endotoxins into bloodstream, which in turn increases with prolonged surgery, degree of hydronephrosis, bacterial load in the renal pelvis, and presence of infected stones.
Charton et al., concluded that without antibiotic prophylaxis 35% of patient suffered urinary tract infection a post-PCNL, although preoperative urine showing no growth. In a prospective but nonrandomized assessment of PCNL patients receiving oral ciprofloxacin, intravenous ciprofloxacin, or no antimicrobial treatment found postoperative urinary tract infection to occur in 17%, 0%, and 40% of patients, respectively. Mariappan et al., stated that midstream urine (MSU) culture does not represent upper tract infection in patients with obstructing stones. Also, stone and pelvic urine cultures are better predictors of upper tract infection and urosepsis in such cases.
Antibiotic prophylaxis has been recommended (Level of evidence: IIb, III) for patients subjected to PCNL to avert these infectious complications, as profiled in an American Urological Association (AUA) Best Practice Policy Statement. They also recommend antibiotic prophylaxis before shock wave lithotripsy and ureteroscopy with high level (Level of evidence: Ia and Ib, respectively) due to presence of meta-analysis and large randomised controlled trial.
The optimal timing, dosing, and duration of a prophylactic antibiotic regimen for PCNL procedures has also been a point of discussion. The AUA best practice policy statement currently recommends that a one-time dose on the day of the procedure is sufficient. The EAU guidelines are less definitive in concluding that a short course is adequate but that the "length of time is to be determined." Mariappan and colleagues in a prospective non-randomised trial found that 52 patients who had dilated collecting systems, stone burden greater than 2 cm, and no confounding factors predisposing to UTIs who received a 1-week course of ciprofloxacin before PCNL had a 3-fold lower risk of postoperative UTI and SIRS than 46 patients who received standard perioperative antibiotics on the day of surgery.
Bag and colleagues prospectively randomized 101 patients with greater than 2.5-cm kidney stones and/or hydronephrosis with sterile preoperative urine cultures to a 7-day course of nitrofurantoin versus no antibiotics before PCNL and found a statistically significant lower rate of postoperative SIRS (19% vs 49%), endotoxemia (18% vs 42%), positive result on kidney urine culture (0% vs 10%), and positive result on stone culture (8% vs 30%) in the arm receiving nitrofurantoin.
Although these two small series support a week of preoperative antibiotics before PCNL, larger, prospective, randomized studies are needed to better elucidate the risks and benefits of empiric antibiotics
- Conditions
- Percutaneous Nephrolithotomy, Infection, Sepsis, Antibiotics
- Being tested
- Levofloxacin, Placebo
- Medical subject headings
- Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called Levofloxacin 500Mg
Levofloxacin 500Mg daily for 5 days
PlaceboDrug
Also called placebo Oral Tablet
Placebo Oral Tablet daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin | Active comparator | Levofloxacin 500 mg daily for 5 days Receives: Drug: Levofloxacin |
| Placebo | Placebo comparator | Placebo tab daily for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper urinary tract infection and systemic inflammatory response syndrome (SIRS) after PCNL by Criteria for SIRS established by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference
SIRS if patient has Two or more of the 4 SIRS criteria
Measured: 1 year
Secondary outcomes (1)
difference between culture and sensitivity of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone.
Preoperative urine (MSU),intraoperative renal pelvic urine and extracted stone culture and sensitivity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion15 Jun 2017 (estimated)
- Study completion15 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Ahmed Shoma, MD, Study chair, Urology and Nephrology centerNasr Eltabey, MD, Study director, Urology and Nephrology centerMahmoud Laimon, Msc, Principal investigator, Urology and Nephrology centerMuhamad Abdullateef, Msc, Principal investigator, Urology and Nephrology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178292
- Sponsor's protocol ID
- Ab-PCNL
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy (PCNL)
- ClinicalTrials.gov ID
- NCT03178292
- Acronym / sponsor ID
- Ab-PCNL
- Conditions
- Percutaneous Nephrolithotomy, Infection, Sepsis, Antibiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 15 Jun 2017 (estimated)
- Study completion
- 15 Jun 2017 (estimated)
- First posted
- 6 Jun 2017 (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.
To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in reducing upper urinary tract infection and urosepsis after PCNL.
Detailed description
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for removal of large volume upper urinary tract stones. Although PCNL is effective and yielding high stone-free rates, complications rates range from 18.30% to 83% with sepsis has been reported in 0.3% to 7.6% of cases result in the most common cause of perioperative mortality in PCNL patients.
Urosepsis after PNL is an important and potentially catastrophic complication. The overall incidence of fever (25%), bacteremia (23%), endotoxemia (34%) and septicemic shock occurs in 0.3%-2.5% of patients. Urosepsis and shock result from the intravasation of bacteria or endotoxins into bloodstream, which in turn increases with prolonged surgery, degree of hydronephrosis, bacterial load in the renal pelvis, and presence of infected stones.
Charton et al., concluded that without antibiotic prophylaxis 35% of patient suffered urinary tract infection a post-PCNL, although preoperative urine showing no growth. In a prospective but nonrandomized assessment of PCNL patients receiving oral ciprofloxacin, intravenous ciprofloxacin, or no antimicrobial treatment found postoperative urinary tract infection to occur in 17%, 0%, and 40% of patients, respectively. Mariappan et al., stated that midstream urine (MSU) culture does not represent upper tract infection in patients with obstructing stones. Also, stone and pelvic urine cultures are better predictors of upper tract infection and urosepsis in such cases.
Antibiotic prophylaxis has been recommended (Level of evidence: IIb, III) for patients subjected to PCNL to avert these infectious complications, as profiled in an American Urological Association (AUA) Best Practice Policy Statement. They also recommend antibiotic prophylaxis before shock wave lithotripsy and ureteroscopy with high level (Level of evidence: Ia and Ib, respectively) due to presence of meta-analysis and large randomised controlled trial.
The optimal timing, dosing, and duration of a prophylactic antibiotic regimen for PCNL procedures has also been a point of discussion. The AUA best practice policy statement currently recommends that a one-time dose on the day of the procedure is sufficient. The EAU guidelines are less definitive in concluding that a short course is adequate but that the "length of time is to be determined." Mariappan and colleagues in a prospective non-randomised trial found that 52 patients who had dilated collecting systems, stone burden greater than 2 cm, and no confounding factors predisposing to UTIs who received a 1-week course of ciprofloxacin before PCNL had a 3-fold lower risk of postoperative UTI and SIRS than 46 patients who received standard perioperative antibiotics on the day of surgery.
Bag and colleagues prospectively randomized 101 patients with greater than 2.5-cm kidney stones and/or hydronephrosis with sterile preoperative urine cultures to a 7-day course of nitrofurantoin versus no antibiotics before PCNL and found a statistically significant lower rate of postoperative SIRS (19% vs 49%), endotoxemia (18% vs 42%), positive result on kidney urine culture (0% vs 10%), and positive result on stone culture (8% vs 30%) in the arm receiving nitrofurantoin.
Although these two small series support a week of preoperative antibiotics before PCNL, larger, prospective, randomized studies are needed to better elucidate the risks and benefits of empiric antibiotics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin | Active comparator | Drug: LevofloxacinLevofloxacin 500 mg daily for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tab daily for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stones ≥ 2.5 cm and/or hydronephrosis
- Sterile mid urine stream
Key exclusion criteria (7 listed)
- Patients with a stent, nephrostomy tube or indwelling catheter
- Uncontrolled Diabetes mellitus
- Renal failure
- Fever before surgery
- 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 |
|---|---|---|
| LevofloxacinAlso: Levofloxacin 500MgLevofloxacin 500Mg daily for 5 days | Drug | Levofloxacin |
| PlaceboAlso: placebo Oral TabletPlacebo Oral Tablet daily for 5 days | Drug | Placebo |
Primary outcome
Upper urinary tract infection and systemic inflammatory response syndrome (SIRS) after PCNL by Criteria for SIRS established by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference
Time frame: 1 year
SIRS if patient has Two or more of the 4 SIRS criteria
1 secondary outcome
difference between culture and sensitivity of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: Yes. Yes meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)
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Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
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Supine vs. Prone Mini-PCNL in Children
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Nephrostomy Tract Infiltration for Pain Control After PCNL
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Not yet recruitingPhase 4
Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy
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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.
Ahmed Shoma, MD study chair
Urology and Nephrology center
Nasr Eltabey, MD study director
Urology and Nephrology center
Mahmoud Laimon, Msc principal investigator
Urology and Nephrology center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levofloxacin in people with Percutaneous Nephrolithotomy and Infection, run by Mansoura 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 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 6 Jun 2017. 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.
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 Abdelwahab R. Hashem, Msc (01069678979 ext. 002, abdelwahab_hashem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper urinary tract infection and systemic inflammatory response syndrome (SIRS) after PCNL by Criteria for SIRS established by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference (time frame: 1 year). 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 6 Jun 2017.