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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- postoperative sepsis
Study Overview
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.
Detailed Description
This study will be a multi-institutional randomized clinical trial of a short course of pre-operative antibiotic prophylaxis in addition to perioperative antibiotics. Once patients have been identified and enrolled into the study, they will be grouped based on the sensitivity profiles of their positive urine culture or the presence of indwelling kidney drain tube (nephrostomy tube, nephroureteral stent, ureteral stent). Each of these groups will be individually randomized as follows:
Group 1) Kidney stone subjects with indwelling drain tube (nephrostomy tube or ureteral stent) and negative urine culture
Randomization:
- 7 day course of oral Macrobid (Nitrofurantoin) 100 mg twice daily + <24 hours perioperative intravenous (IV) antibiotics
- 48 hours perioperative oral Macrobid (Nitrofurantoin) 100mg twice daily + <24 hours perioperative IV antibiotics
Group 2) Kidney stone subjects with positive urine culture sensitive to oral antibiotics
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Gentamicin, 5mg/kg (Drug)
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.
Intervention: Ampicillin 2g (Drug)
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.
Intervention: Nitrofurantoin 100 mg, 48 hrs (Drug)
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.
Intervention: Nitrofurantoin 100 MG, 7d (Drug)
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.
Intervention: Gentamicin, 5mg/kg (Drug)
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.
Intervention: Ampicillin 2g (Drug)
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.
Intervention: Gentamicin, 5mg/kg (Drug)
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.
Intervention: Ampicillin 2g (Drug)
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.
Intervention: Nitrofurantoin 100 mg, 48 hrs (Drug)
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.
Intervention: Nitrofurantoin 100 MG, 7d (Drug)
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.
Intervention: Gentamicin, 5mg/kg (Drug)
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.
Intervention: Ampicillin 2g (Drug)
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.
Intervention: Gentamicin, 5mg/kg (Drug)
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.
Intervention: Ampicillin 2g (Drug)
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.
Intervention: Gentamicin, 80 mg, 48hr (Drug)
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.
Intervention: Gentamicin, 5mg/kg (Drug)
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.
Intervention: Ampicillin 2g (Drug)
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.
Intervention: Gentamicin, 80 mg, 7d (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- stone-free rate(30 days)
- Length of hospital stay(30 days)
- rate of nonseptic bacteruria(30 days)
Investigators
Roger L Sur, M.D.
Professor of Surgery
University of California, San Diego