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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 : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Roger L Sur, M.D., University of California, San Diego

Study Description
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Brief Summary:
This study will be a multi-institutional randomized clinical trial of a short course of pre-operative antibiotic prophylaxis in addition to perioperative antibiotics prior to undergoing percutaneous nephrolithotomy. The select patient population will be those patients deemed to be at a moderately increased risk of postoperative infectious complications. These higher risk patients are those with indwelling urinary drainage tubes and those with a positive preoperative urine culture.

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

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Study Design
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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 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1a: Indwelling drains (48 hr)

This group has indwelling urinary tubes/drains and a negative urine culture

  • Nitrofurantoin (Macrobid) 100 mg oral bid for 48 hours prior to surgery
  • All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
 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

  • Nitrofurantoin (Macrobid) 100 mg oral bid for 7 days prior to surgery
  • All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
 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

  • Nitrofurantoin (Macrobid) 100 mg oral bid for 48 hours prior to surgery
  • If patient has previous allergies to Macrobid and/or sensitivity profile indicates Macrobid resistance, then one antibiotic will be provided in the following order: nitrofurantoin > sulfamethoxazole-trimethoprim > doxycycline> ciprofloxacin > cephalexin > cefpodoxime.
  • All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
 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

  • Nitrofurantoin (Macrobid) 100 mg oral bid for 7 days prior to surgery
  • If patient has previous allergies to Macrobid and/or sensitivity profile indicates Macrobid resistance, then one antibiotic will be provided in the following order: nitrofurantoin > sulfamethoxazole-trimethoprim > doxycycline> ciprofloxacin > cephalexin > cefpodoxime.
  • All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
 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

  • 48 hour course of an IV/Intramuscular (IM) antibiotic (proven effective on sensitivity profile)
  • Gentamicin (80 mg) preferred if sensitive
  • All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
 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

  • 7 day course of an IV/Intramuscular (IM) antibiotic (proven effective on sensitivity profile)
  • Gentamicin (80 mg) preferred if sensitive
  • All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Length of hospital stay [ Time Frame: 30 days ]
    hospital day defined as any inpatient stay < or = 24 hours


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Roger L Sur, MD 619-543-2628 rlsur@ucsd.edu
Contact: Joel E Abbott, DO 619-543-2628 jabbott@westernu.edu

Locations
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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         
Sponsors and Collaborators
University of California, San Diego
More Information
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Publications of Results:

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Responsible Party: Roger L Sur, M.D., Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02829060     History of Changes
Other Study ID Numbers: 160158
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: RedCap Password Protected Data Share System
Keywords provided by Roger L Sur, M.D., University of California, San Diego:
nephrolithiasis
percutaneous nephrolithiasis
urinary tract infection (UTI)
Sepsis
Additional relevant MeSH terms:
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Ampicillin
Infection
Urinary Tract Infections
Nephrolithiasis
Kidney Calculi
Urologic Diseases
Kidney Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
 Anti-Bacterial Agents
Gentamicins
Nitrofurantoin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents