Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2

NCT02829060 | Completed

• 1 other identifier: 160158
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis; Urinary Tract Infection (UTI); Sepsis

Keywords

nephrolithiasis; percutaneous nephrolithiasis; urinary tract infection (UTI); Sepsis

Outcome Measures

Primary Outcomes (1)

• postoperative sepsis

  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

  30 days

Secondary Outcomes (3)

• rate of nonseptic bacteruria

  30 days

• stone-free rate

  30 days

• Length of hospital stay

  30 days

Study Arms (6)

1a: Indwelling drains (48 hr)

ACTIVE COMPARATOR

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; Drug: Ampicillin 2g; Drug: Nitrofurantoin 100 mg, 48 hrs

1b: Indwelling drains (7d)

ACTIVE COMPARATOR

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; Drug: Gentamicin, 5mg/kg; Drug: Ampicillin 2g

2a: +UCx with Oral Options (48hr)

ACTIVE COMPARATOR

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; Drug: Ampicillin 2g; Drug: Nitrofurantoin 100 mg, 48 hrs

2b: +UCx with Oral Options (7d)

ACTIVE COMPARATOR

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; Drug: Gentamicin, 5mg/kg; Drug: Ampicillin 2g

3a: +UCx No Oral options (48hr)

ACTIVE COMPARATOR

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; Drug: Ampicillin 2g; Drug: Gentamicin, 80 mg, 48hr

3b: +UCx No Oral options (7d)

ACTIVE COMPARATOR

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; Drug: Ampicillin 2g; Drug: Gentamicin, 80 mg, 7d

Interventions

Nitrofurantoin 100 MG, 7d DRUG

7 day course, 100 mg twice daily, PO

Also known as: Macrobid

1b: Indwelling drains (7d); 2b: +UCx with Oral Options (7d)

Gentamicin, 5mg/kg DRUG

Peri-operative dose: 5 mg/kg of ideal body weight, IV

Also known as: Gentamicin

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)

Ampicillin 2g DRUG

Peri-operative dose: 2 grams, IV

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)

Nitrofurantoin 100 mg, 48 hrs DRUG

48 hour course, 100 mg twice daily, PO

Also known as: Macrobid

1a: Indwelling drains (48 hr); 2a: +UCx with Oral Options (48hr)

Gentamicin, 80 mg, 7d DRUG

7 day course, 80 mg daily, IM or IV

3b: +UCx No Oral options (7d)

Gentamicin, 80 mg, 48hr DRUG

48 hour course, 80 mg daily, IM or IV

3a: +UCx No Oral options (48hr)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• Patients age \<18
• Active pregnancy
• Patients receiving antibiotic doses (other than prescribed for the study) within the seven days preceding surgery

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92101, United States

Location

Related Publications (6)

• de la Rosette J, Assimos D, Desai M, Gutierrez J, Lingeman J, Scarpa R, Tefekli A; CROES PCNL Study Group. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: indications, complications, and outcomes in 5803 patients. J Endourol. 2011 Jan;25(1):11-7. doi: 10.1089/end.2010.0424.

  PMID: 21247286 RESULT

• Korets R, Graversen JA, Kates M, Mues AC, Gupta M. Post-percutaneous nephrolithotomy systemic inflammatory response: a prospective analysis of preoperative urine, renal pelvic urine and stone cultures. J Urol. 2011 Nov;186(5):1899-903. doi: 10.1016/j.juro.2011.06.064. Epub 2011 Sep 23.

  PMID: 21944106 RESULT

• Kumar S, Bag S, Ganesamoni R, Mandal AK, Taneja N, Singh SK. Risk factors for urosepsis following percutaneous nephrolithotomy: role of 1 week of nitrofurantoin in reducing the risk of urosepsis. Urol Res. 2012 Feb;40(1):79-86. doi: 10.1007/s00240-011-0386-6. Epub 2011 May 13.

  PMID: 21567157 RESULT

• Bag S, Kumar S, Taneja N, Sharma V, Mandal AK, Singh SK. One week of nitrofurantoin before percutaneous nephrolithotomy significantly reduces upper tract infection and urosepsis: a prospective controlled study. Urology. 2011 Jan;77(1):45-9. doi: 10.1016/j.urology.2010.03.025. Epub 2010 Jun 8.

  PMID: 20570319 RESULT

• Wolf JS Jr, Bennett CJ, Dmochowski RR, Hollenbeck BK, Pearle MS, Schaeffer AJ; Urologic Surgery Antimicrobial Prophylaxis Best Practice Policy Panel. Best practice policy statement on urologic surgery antimicrobial prophylaxis. J Urol. 2008 Apr;179(4):1379-90. doi: 10.1016/j.juro.2008.01.068. Epub 2008 Feb 20.

  PMID: 18280509 RESULT

• Sur RL, Krambeck AE, Large T, Bechis SK, Friedlander DF, Monga M, Hsi RS, Miller NL, Chew BH, Lange D, Knudsen B, Sourial MW, Humphreys MR, Stern KL, Shah O, Abbott JE, Abedi G. A Randomized Controlled Trial of Preoperative Prophylactic Antibiotics for Percutaneous Nephrolithotomy in Moderate to High Infectious Risk Population: A Report from the EDGE Consortium. J Urol. 2021 May;205(5):1379-1386. doi: 10.1097/JU.0000000000001582. Epub 2020 Dec 28.

  PMID: 33369488 DERIVED

MeSH Terms

Conditions

Nephrolithiasis; Urinary Tract Infections; Sepsis

Interventions

Nitrofurantoin; Gentamicins; Ampicillin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: July 12, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)