Kidney StonesPhase 3NCT02579161
Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
A Phase 3 study testing cephalosporins, Fluoroquinolones and Clindamycin in people with Kidney Stones, run by Northwell Health at 2 sites in United States.
Trial summary
The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones
- What is being tested?
- cephalosporins, Fluoroquinolones and Clindamycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years old
- Negative urine culture within 1 month prior to procedure
- Renal Calculi which would optimally require PCNL for treatment.
Who cannot join
- Patients <18 years old.
- Patients who are not able to give consent for study
- Patients currently on antibiotics immediately prior to the procedure
- Previous history of sepsis or SIRS from stone manipulations
- Foley catheter in place for greater than 1 week duration
- Patients under going planned, multi-staged procedures
- Immunosuppressed patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Shore University Hospital
Manhasset, New York, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
About this study
The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
Read the detailed description
For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. However, PCNL is not without its complications, specifically infectious. The procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore, the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines for the appropriate duration and class of antibiotics. This fact leaves the practicing urologists to their own subjective experiences to the guide them. In addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount.
The investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. The investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics until the removal of any external catheters. The investigators will model the antibiotics choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary. The investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
Antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone
Looking at the same drugs and doses the variable is the timeframe of the medication
- Conditions
- Kidney Stones
- Being tested
- cephalosporins, Fluoroquinolones, Clindamycin, Ampicillin/Gentamicin
- Keywords
- Percutaneous Nephrolithotomy, Kidney Stones, Antibiotics
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalosporinsDrug
Also called ancef
Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed
FluoroquinolonesDrug
Also called ciprofloxacin
If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance
ClindamycinDrug
Also called Lincosamides
If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.
Ampicillin/GentamicinDrug
Also called Penicillinase-sensitive penicillin\Aminoglycoside
5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics for a 24 hour period | Active comparator | Antibiotics for a 24 hour period
Intervention drug to be determined based on patient history etc. Receives: Drug: cephalosporins; Drug: Fluoroquinolones; Drug: Clindamycin; Drug: Ampicillin/Gentamicin |
| Continued antibiotics | Active comparator | Continued antibiotics until the removal of any external catheters
Intervention drug to be determined based on patient history etc. Receives: Drug: cephalosporins; Drug: Fluoroquinolones; Drug: Clindamycin; Drug: Ampicillin/Gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Infectious Complications
Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.
Measured: 0-30 days post-operatively
Secondary outcomes (2)
Length of Stay (Days)
Length of Hospital Stay After Surgery (days)
Measured: 0-30 days post operatively
Number of Participants With Associated Clavien Grade of Adverse Event
Overall complication rates are reported based on Clavien-Dindo scale. The numbers reported are recorded Clavien complications. There is only one Clavien complication per patient as such a recorded number indicates one complication of this classification and also one patient with this complication. For example, if a Clavien III is recorded, it is indicating that one patient in that study group had one Clavien III complication.
Grade I are any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention.
Grade II complications require drug treatments other than those allowed for Grade I complications; Grade III complications require surgical, endoscopic or radiological intervention either IIIa, not under general anesthesia or IIIb, under general anesthesia. Grade IV are Life-threatening complications. Grade V are most severe and result in death of the patient.
Measured: 0 to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeph Okeke, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579161
- Sponsor's protocol ID
- 14-003
- Status last verified
- Sep 2023
- First submitted
- 19 Jun 2014
- Last updated
- 6 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Griffiths L, Aro T, Samson P, Derisavifard S, Gaines J, Alaiev D, Mullen G, Rai A, Williams T, Patel V, Guanay G, Leavitt D, Hartman C, Smith A, Hoenig D, Okeke Z. Prospective Randomized Trial of Antibiotic Prophylaxis Duration for Percutaneous Nephrolithotomy in Low-Risk Patients. J Endourol. 2023 Oct;37(10):1075-1080. doi: 10.1089/end.2022.0678.
PubMed 37578113
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT02579161
- Acronym / sponsor ID
- 14-003
- Conditions
- Kidney Stones
- Keywords
- Percutaneous Nephrolithotomy, Kidney Stones, Antibiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
Detailed description
For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. However, PCNL is not without its complications, specifically infectious. The procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore, the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines for the appropriate duration and class of antibiotics. This fact leaves the practicing urologists to their own subjective experiences to the guide them. In addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount.
The investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. The investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics until the removal of any external catheters. The investigators will model the antibiotics choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary. The investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
Antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone
Looking at the same drugs and doses the variable is the timeframe of the medication
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics for a 24 hour period | Active comparator | Drug: cephalosporins, Drug: Fluoroquinolones, Drug: Clindamycin, Drug: Ampicillin/GentamicinAntibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. |
| Continued antibiotics | Active comparator | Drug: cephalosporins, Drug: Fluoroquinolones, Drug: Clindamycin, Drug: Ampicillin/GentamicinContinued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 years old
- Negative urine culture within 1 month prior to procedure
- Renal Calculi which would optimally require PCNL for treatment.
Key exclusion criteria (7 listed)
- Patients <18 years old.
- Patients who are not able to give consent for study
- Patients currently on antibiotics immediately prior to the procedure
- Previous history of sepsis or SIRS from stone manipulations
- Foley catheter in place for greater than 1 week duration
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 |
|---|---|---|
| cephalosporinsAlso: ancefPatients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed | Drug | Antibiotics for a 24 hour period, Continued antibiotics |
| FluoroquinolonesAlso: ciprofloxacinIf the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance | Drug | Antibiotics for a 24 hour period, Continued antibiotics |
| ClindamycinAlso: LincosamidesIf allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision. | Drug | Antibiotics for a 24 hour period, Continued antibiotics |
| Ampicillin/GentamicinAlso: Penicillinase-sensitive penicillin\Aminoglycoside5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin | Drug | Antibiotics for a 24 hour period, Continued antibiotics |
Primary outcome
Number of Participants With Infectious Complications
Time frame: 0-30 days post-operatively
Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.
2 secondary outcomes
Length of Stay (Days)
Time frame: 0-30 days post operatively
Number of Participants With Associated Clavien Grade of Adverse Event
Time frame: 0 to 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37578113Griffiths L, Aro T, Samson P, Derisavifard S, Gaines J, Alaiev D, Mullen G, Rai A, Williams T, Patel V, Guanay G, Leavitt D, Hartman C, Smith A, Hoenig D, Okeke Z. Prospective Randomized Trial of Antibiotic Prophylaxis Duration for Percutaneous Nephrolithotomy in Low-Risk Patients. J Endourol. 2023 Oct;37(10):1075-1080. doi: 10.1089/end.2022.0678.
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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.
Zeph Okeke, MD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cephalosporins, Fluoroquinolones and Clindamycin in people with Kidney Stones, run by Northwell Health at 2 sites in United States.
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: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Infectious Complications (time frame: 0-30 days post-operatively). 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 NCT02579161, 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 6 Sep 2023.