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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking antibiotics before kidney stone surgery can reduce the risk of postoperative infections. It targets individuals more prone to infections after surgery, such as those with a positive urine test for bacteria or urinary tract tubes. Participants may receive different antibiotics, like Ampicillin or Gentamicin, based on their specific condition. This trial suits individuals recommended for kidney stone surgery who have a positive urine test or urinary tubes. As an unphased trial, it allows patients to contribute to significant research that could enhance surgical outcomes for many.

Will I have to stop taking my current medications?

The trial requires that you stop taking any antibiotics not prescribed for the study within the seven days before surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ampicillin, gentamicin, and nitrofurantoin are generally safe, though they can have side effects. Ampicillin is usually well-tolerated, but prolonged use can affect the liver. Gentamicin often treats serious infections, but it can sometimes harm the kidneys, especially with extended use. Nitrofurantoin commonly treats urinary tract infections and is generally safe, but caution is advised for those with kidney problems.

The FDA has approved these antibiotics for treating various infections, indicating a safety record. However, following dosing instructions is crucial to reduce risks. Consult a healthcare provider with any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these antibiotic protocols for kidney stone surgery because they aim to optimize pre-operative infection control. Unlike the standard care that often involves a one-size-fits-all approach with broad-spectrum antibiotics, this trial tailors antibiotic use based on individual urine culture results. By using targeted antibiotics, like gentamicin and nitrofurantoin, and considering sensitivity profiles, the trial seeks to reduce antibiotic resistance and improve surgical outcomes. Additionally, the protocols include both short-term (48-hour) and extended (7-day) antibiotic courses, potentially offering more personalized and effective infection prevention.

What evidence suggests that this trial's treatments could be effective for preventing postoperative infections in kidney stone surgery?

In this trial, participants will receive different antibiotic regimens before kidney stone surgery to lower infection risk. One group will receive ampicillin and gentamicin, which research has shown effectively prevent infections when given before surgery. Another group will receive nitrofurantoin, effective for treating urinary infections, especially when guided by test results. These antibiotics are used in various treatment arms to reduce post-surgery infection risk, particularly in patients at higher risk, such as those with existing urinary drainage tubes or positive urine cultures. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11876188/

Antibiotic prophylaxis in stone surgery: a systematic review ... Conclusions. Antibiotic prophylaxis strategies for stone surgery show different degrees of effectiveness depending on both the approach and the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29684391/

A Randomized Controlled Trial of Preoperative ... Conclusions: Our study demonstrated no advantage to providing 1 week of preoperative oral antibiotics in patients at low risk for infectious complications who ...

3. chi.gov.sa chi.gov.sa/Style%20Library/IDF_Branding/Indication/207%20-%20Surgical%20Antimicrobial%20Prophylaxis-New%20Indication.pdf

SURGICAL ANTIMICROBIAL PROPHYLAXIS It is crucial for pre-operative antibiotics to achieve effective tissue concentrations before incision, with a suggested optimal window of ...

4. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/508349

Use of Antimicrobial Prophylaxis for Major Surgery ... This report describes baseline results of an assessment of use of antimicrobial prophylaxis for a national sample of Medicare patients undergoing 5 types of ...

5. researchgate.net researchgate.net/publication/389515051_Antibiotic_prophylaxis_in_stone_surgery_a_systematic_review_of_the_literature

Antibiotic prophylaxis in stone surgery: a systematic review ... Conclusions Antibiotic prophylaxis strategies for stone surgery show different degrees of effectiveness depending on both the approach and the patient's ...

6. cdn.pfizer.com cdn.pfizer.com/pfizercom/products/material_safety_data/230.pdf

MATERIAL SAFETY DATA SHEET May cause damage to liver through prolonged or repeated exposure. Additional Hazard Information: Short Term: Accidental ingestion may cause effects similar to ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/050608s047lbl.pdf

UNASYN® (ampicillin sodium/sulbactam sodium) Pediatric Patients: Available safety data for pediatric patients treated with UNASYN demonstrate a similar adverse events profile to those observed in adult ...

8. pfizerhospitalus.com pfizerhospitalus.com/product/00049-0014-83

Unasyn® (ampicillin sodium /sulbactam sodium) Unasyn® (ampicillin sodium /sulbactam sodium). 3 g. Vial. Unit of Sale NDC ... Garnet. Product insert Safety data sheet. Wholesalers. Cardinal, 1458561.

9. mayoclinic.org mayoclinic.org/drugs-supplements/ampicillin-and-sulbactam-injection-route/description/drg-20072723

Ampicillin and sulbactam (injection route) - Side effects & ... Safety and efficacy have not been established. Geriatric. No information is available on the relationship of age to the effects of ampicillin ...

10. empr.com empr.com/drug/unasyn/

UNASYN Prescription & Dosage Information - MPR Ampicillin is similar to benzyl penicillin in its bactericidal action against susceptible organisms during the stage of active multiplication.