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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
PNLABXPART2 Trial 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.Check my eligibility
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.See study design
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.
PNLABXPART2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a kidney stone recommended for PCNL treatment.
PNLABXPART2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Septicemia
Secondary outcome measures
Length of hospital stay
rate of nonseptic bacteruria
stone-free rate
PNLABXPART2 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.
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,520,594 Total Patients Enrolled
6 Trials studying Kidney Stones
3,712 Patients Enrolled for Kidney Stones
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a kidney stone recommended for PCNL treatment.I have taken antibiotics not prescribed for this study within the last week.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.You are currently pregnant.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: 3b: +UCx No Oral options (7d)
- Group 2: 1a: Indwelling drains (48 hr)
- Group 3: 1b: Indwelling drains (7d)
- Group 4: 2a: +UCx with Oral Options (48hr)
- Group 5: 2b: +UCx with Oral Options (7d)
- Group 6: 3a: +UCx No Oral options (48hr)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does 3b: +UCx No Oral options (7d) typically benefit patients?
"Staphylococcal infections are commonly treated using the regimen 3b: +UCx No Oral options (7d). This prescription can also be beneficial when managing endocarditis, pyoderma gangrenosum, and genitourinary tract infection."
Answered by AI
Are there any openings available for persons to participate in this clinical trial?
"That is accurate. According to clinicaltrials.gov, this medical study posted on January 1st 2016 and recently updated in March 2020 is currently recruiting for around 330 total participants from a single site."
Answered by AI
What is the participant count in this clinical research?
"Affirmative. Clinicaltrials.gov states that this clinical trial, which went live on the 1st of January 2016, is actively recruiting subjects for participation. A total of 330 patients from a single site are necessary to fulfill research requirements."
Answered by AI
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