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Antibiotic

Antibiotic Prophylaxis for Kidney Stones (APPEAL Trial)

Phase 4
Recruiting
Led By Philippe D Violette, MD CM
Research Sponsored by Clinical Urology and Epidemiology Working Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Presence of Foley catheter or patient on regular clean intermittent catheterization (CIC)
Presence of urinary diversion (ie: ileal conduit)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days post-shockwave lithotripsy
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
Approved for 40 Other Conditions

Summary

This trial is testing whether using a single dose of ciprofloxacin before Shock Wave Lithotripsy (SWL) is better than using saline alone. The trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.

Who is the study for?
This trial is for adults over 18 with kidney or ureter stones scheduled for shock wave lithotripsy (SWL). Participants must not have a specific type of stone called struvite, any urinary diversions, history of severe infection after SWL, allergies to the study antibiotic, or be on antibiotics for UTI. They also shouldn't have certain conditions that make joining the trial not in their best interest.
What is being tested?
The study compares two treatments before SWL: one group receives a single dose of an antibiotic called Ciprofloxacin and the other gets a saline placebo. It's a double-blind RCT which means neither patients nor doctors know who's getting what treatment. The trial includes various international medical centers.
What are the potential side effects?
Ciprofloxacin may cause side effects like nausea, diarrhea, headaches, and rarely more serious issues such as tendon problems or nerve damage. Placebo typically has no active ingredients but can sometimes cause injection site reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I use a catheter regularly for urination.
Select...
I have a urinary diversion in place.
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I need a bladder scope and stent placement on the same day as my shock wave therapy.
Select...
I have had a severe urinary infection before undergoing a kidney stone procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days post-shockwave lithotripsy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days post-shockwave lithotripsy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis
Secondary study objectives
Bacteriuria defined as ≥ 100000 Colony Forming Unit/ml
Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome)
Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome)
+3 more

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 40 Other Conditions
This treatment demonstrated efficacy for 40 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ciprofloxacinExperimental Treatment1 Intervention
Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy
Group II: PlaceboPlacebo Group1 Intervention
identical oral placebo if oral cipro was used, or intravenous saline alone in a blinded fashion if IV cipro was used prior to shockwave lithotripsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ciprofloxacin
FDA approved

Find a Location

Who is running the clinical trial?

Dr Cipto Mangunkusumo General HospitalOTHER
43 Previous Clinical Trials
10,112 Total Patients Enrolled
Hospital Sao LuizOTHER
Tallaght University HospitalOTHER
8 Previous Clinical Trials
642 Total Patients Enrolled

Media Library

Ciprofloxacin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03692715 — Phase 4
Kidney stones Research Study Groups: ciprofloxacin, Placebo
Kidney stones Clinical Trial 2023: Ciprofloxacin Highlights & Side Effects. Trial Name: NCT03692715 — Phase 4
Ciprofloxacin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03692715 — Phase 4
~20 spots leftby Dec 2024
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