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Antibiotic

Antibiotics Before Surgery for Kidney Stones (PNLABXPART2 Trial)

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Renal stone of any size for which PCNL is recommended

Must not have

Patients age <18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial will study the effect of a short course of antibiotics before surgery for patients at a moderately increased risk of postoperative infection.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions, nausea, diarrhea from Nitrofurantoin; and kidney damage, hearing loss from Gentamicin. Ampicillin may cause rash and digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a kidney stone recommended for PCNL treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Septicemia

Secondary study objectives

Length of hospital stay

rate of nonseptic bacteruria

stone-free rate

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Active Control

Group I: 3b: +UCx No Oral options (7d)Active Control3 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 Control3 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 Control3 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 Control3 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 Control3 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 Control3 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.

0 / 2Eligibility criteria met