Antibiotics Before Surgery for Kidney Stones

(PNLABXPART2 Trial)

Overseen By Joel E Abbott, DO

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Antibiotics

Disqualifiers: Age <18, Active pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

330 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with kidney stones who are at moderate risk of infection after surgery, specifically those with a positive urine culture or internal urinary drainage tubes. It's not for anyone under 18, pregnant women, or patients on antibiotics within the week before surgery.

Inclusion Criteria

I have a kidney stone recommended for PCNL treatment.

You currently have a tube inside your body to help drain urine.

You have had a urinary tract infection in the three months before the surgery.

Exclusion Criteria

I have taken antibiotics not prescribed for this study within the last week.

You are currently pregnant.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Antibiotic Prophylaxis

Participants receive a short course of pre-operative antibiotic prophylaxis based on their group assignment

7 days or 48 hours

1 visit (in-person) for randomization and prescription

Surgery and Perioperative Care

Participants undergo percutaneous nephrolithotomy (PCNL) with perioperative antibiotics administered

<24 hours

1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment for postoperative sepsis and stone-free status

30 days

1-2 visits (in-person) for follow-up assessments

Treatment Details

Interventions

• Ampicillin
• Gentamicin
• Nitrofurantoin

Trial Overview The study tests if taking a short course of pre-operative antibiotics (Nitrofurantoin or Gentamicin) in addition to perioperative antibiotics reduces post-surgery infections in patients undergoing kidney stone removal by PCNL.

Participant Groups

Group I: 3b: +UCx No Oral options (7d) Active Control 3 Interventions

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.

Group II: 1a: Indwelling drains (48 hr) Active Control 3 Interventions

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.

Group III: 1b: Indwelling drains (7d) Active Control 3 Interventions

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.

Group IV: 2a: +UCx with Oral Options (48hr) Active Control 3 Interventions

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.

Group V: 2b: +UCx with Oral Options (7d) Active Control 3 Interventions

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.

Group VI: 3a: +UCx No Oral options (48hr) Active Control 3 Interventions

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.

Ampicillin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ampicillin for:

• Bacterial infections
• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Gastrointestinal infections

Approved in European Union as Ampicillin for:

• Bacterial infections
• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Gastrointestinal infections

Approved in Canada as Ampicillin for:

• Bacterial infections
• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Gastrointestinal infections

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+