Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2 (PNLABXPART2)
Nephrolithiasis, Urinary Tract Infection (UTI), Sepsis
About this trial
This is an interventional prevention trial for Nephrolithiasis focused on measuring nephrolithiasis, percutaneous nephrolithiasis, urinary tract infection (UTI), Sepsis
Eligibility 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
Sites / Locations
- University of California San DiegoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
1a: Indwelling drains (48 hr)
1b: Indwelling drains (7d)
2a: +UCx with Oral Options (48hr)
2b: +UCx with Oral Options (7d)
3a: +UCx No Oral options (48hr)
3b: +UCx No Oral options (7d)
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.
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.
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.
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.
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.
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.