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Antibiotic Duration for Kidney Stone Surgery
N/A
Waitlist Available
Led By Thomas Chi, MD, MBA
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
immunosuppression (such as for transplant recipients, active chemotherapy use)
bowel interposition (such as ileal conduit, neobladder)
Must not have
active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up obtained during the peri-operative period
Awards & highlights
No Placebo-Only Group
Summary
This trial compares short vs long pre-op antibiotics for patients at risk of infection during ureteroscopy to test if there's any difference in safety and efficacy.
Who is the study for?
This trial is for adults over 18 with kidney stones who are at moderate to high risk of infection and planning to undergo ureteroscopy. They may have a stent, nephrostomy tube, or use catheters like foley or suprapubic. People with asymptomatic bacteriuria, bowel interposition, or immunosuppression can join. Pregnant individuals, those with active infections or recent non-study antibiotics cannot participate.
What is being tested?
The study compares the effectiveness of taking antibiotics for two days versus seven days before ureteroscopy in preventing post-operative infections. It's a randomized controlled trial aiming to see if a shorter antibiotic course is just as good as a longer one for patients at higher risk of complications.
What are the potential side effects?
Potential side effects from the antibiotics could include allergic reactions, gastrointestinal issues like nausea and diarrhea, yeast infections due to disruption of normal body flora, and possibly increased resistance to antibiotics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on immunosuppressants, possibly for a transplant or chemotherapy.
Select...
I have had surgery to create a new way for urine to leave my body.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any current infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
infectious complication rate
Secondary study objectives
Adverse reaction to antibiotic regimen
Identification of secondary markers of post-operative sepsis
Non-infectious complications including readmission
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Short duration of preoperative antibiotics (2 days)Experimental Treatment1 Intervention
Group II: Long duration of preoperative antibiotics (7 days)Active Control1 Intervention
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,586 Previous Clinical Trials
14,899,974 Total Patients Enrolled
Thomas Chi, MD, MBAPrincipal InvestigatorUniversity of California, San Francisco
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