Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2 (PNLABXPART2)
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ClinicalTrials.gov Identifier: NCT02829060 |
Recruitment Status :
Recruiting
First Posted : July 12, 2016
Last Update Posted : March 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nephrolithiasis Urinary Tract Infection (UTI) Sepsis | Drug: Nitrofurantoin 100 MG, 7d Drug: Gentamicin, 5mg/kg Drug: Ampicillin 2g Drug: Nitrofurantoin 100 mg, 48 hrs Drug: Gentamicin, 80 mg, 7d Drug: Gentamicin, 80 mg, 48hr | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | The Endourology Disease Group for Excellence (EDGE) Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy in Patients With Moderate Risk of Postoperative Infection |
Actual Study Start Date : | January 2016 |
Estimated Primary Completion Date : | January 2025 |
Estimated Study Completion Date : | January 2025 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1a: Indwelling drains (48 hr)
This group has indwelling urinary tubes/drains and a negative urine culture
|
Drug: Gentamicin, 5mg/kg
Peri-operative dose: 5 mg/kg of ideal body weight, IV
Other Name: Gentamicin Drug: Ampicillin 2g Peri-operative dose: 2 grams, IV Drug: Nitrofurantoin 100 mg, 48 hrs 48 hour course, 100 mg twice daily, PO
Other Name: Macrobid |
Active Comparator: 1b: Indwelling drains (7d)
This group has indwelling urinary tubes/drains and a negative urine culture
|
Drug: Nitrofurantoin 100 MG, 7d
7 day course, 100 mg twice daily, PO
Other Name: Macrobid Drug: Gentamicin, 5mg/kg Peri-operative dose: 5 mg/kg of ideal body weight, IV
Other Name: Gentamicin Drug: Ampicillin 2g Peri-operative dose: 2 grams, IV |
Active Comparator: 2a: +UCx with Oral Options (48hr)
This group has a positive pre-operative urine culture with oral antibiotic options
|
Drug: Gentamicin, 5mg/kg
Peri-operative dose: 5 mg/kg of ideal body weight, IV
Other Name: Gentamicin Drug: Ampicillin 2g Peri-operative dose: 2 grams, IV Drug: Nitrofurantoin 100 mg, 48 hrs 48 hour course, 100 mg twice daily, PO
Other Name: Macrobid |
Active Comparator: 2b: +UCx with Oral Options (7d)
This group has a positive pre-operative urine culture with oral antibiotic options
|
Drug: Nitrofurantoin 100 MG, 7d
7 day course, 100 mg twice daily, PO
Other Name: Macrobid Drug: Gentamicin, 5mg/kg Peri-operative dose: 5 mg/kg of ideal body weight, IV
Other Name: Gentamicin Drug: Ampicillin 2g Peri-operative dose: 2 grams, IV |
Active Comparator: 3a: +UCx No Oral options (48hr)
This group has a positive pre-operative urine culture with no oral antibiotic options based on culture sensitivities
|
Drug: Gentamicin, 5mg/kg
Peri-operative dose: 5 mg/kg of ideal body weight, IV
Other Name: Gentamicin Drug: Ampicillin 2g Peri-operative dose: 2 grams, IV Drug: Gentamicin, 80 mg, 48hr 48 hour course, 80 mg daily, IM or IV |
Active Comparator: 3b: +UCx No Oral options (7d)
This group has a positive pre-operative urine culture with no oral antibiotic options based on culture sensitivities
|
Drug: Gentamicin, 5mg/kg
Peri-operative dose: 5 mg/kg of ideal body weight, IV
Other Name: Gentamicin Drug: Ampicillin 2g Peri-operative dose: 2 grams, IV Drug: Gentamicin, 80 mg, 7d 7 day course, 80 mg daily, IM or IV |
- postoperative sepsis [ Time Frame: 30 days ]
Sepsis will be defined by the 2012 International Guidelines for the Management of Severe Sepsis and Septic Shock where 2 or more of the following variables are present and temporally associated
- Temp > 38.3C or <36C
- Heart Rate > 90/min (at least 12 hrs after surgery)
- Respiratory Rate >20/min (at least 12 hrs after surgery)
- Altered mental status: defined as lack of orientation to either name, place or time/date
- Systolic Blood Pressure (SBP) <90 mmHg, Mean Arterial Pressure <70 mmHg, or SBP decrease >40 mmHg in adults
- White blood cell (WBC) > 12000 or <4000
- rate of nonseptic bacteruria [ Time Frame: 30 days ]-non septic bacteria is the presence of any colony forming units on urine culture where sepsis is not present
- stone-free rate [ Time Frame: 30 days ]stone free defined as absence of kidney stone on all post-operative imaging (plain kidney-ureter-bladder X-ray or renal ultrasound or computed tomography)
- Length of hospital stay [ Time Frame: 30 days ]hospital day defined as any inpatient stay < or = 24 hours

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Age: >17 years of age
Gender: both men and women included. We anticipated enrolling a study population of approximately 60% men and 40% women based on a higher incidence of kidney stones among men in NHANES data.
Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions.
Health status: see below for specific inclusion/exclusion criteria.
Inclusion criteria:
- Renal stone of any size for which PCNL is recommended
- Positive preoperative urine culture within 3 months
- Current internalized ureteral stent, nephrostomy tube, nephroureteral stent
Exclusion criteria
- Patients age <18
- Active pregnancy
- Patients receiving antibiotic doses (other than prescribed for the study) within the seven days preceding surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829060
Contact: Roger L Sur, MD | 619-543-2628 | rlsur@ucsd.edu | |
Contact: Joel E Abbott, DO | 619-543-2628 | jabbott@westernu.edu |
United States, California | |
University of California San Diego | Recruiting |
San Diego, California, United States, 92101 | |
Contact: Roger L Sur, MD 619-543-2628 rlsur@ucsd.edu | |
Contact: Joel E Abbott, DO 619-543-2628 jabbott@westernu.edu | |
Sub-Investigator: Seth K Bechis, MD |
Responsible Party: | Roger L Sur, M.D., Professor of Surgery, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT02829060 |
Other Study ID Numbers: |
160158 |
First Posted: | July 12, 2016 Key Record Dates |
Last Update Posted: | March 24, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | RedCap Password Protected Data Share System |
nephrolithiasis percutaneous nephrolithiasis urinary tract infection (UTI) Sepsis |
Ampicillin Infection Urinary Tract Infections Nephrolithiasis Kidney Calculi Urologic Diseases Kidney Diseases Urolithiasis Urinary Calculi Calculi |
Pathological Conditions, Anatomical Gentamicins Nitrofurantoin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |