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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days post-shockwave lithotripsy
Awards & highlights
APPEAL Trial 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.Check my eligibility
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.See study design
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.
APPEAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-14 days post-shockwave lithotripsy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days post-shockwave lithotripsy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis
Secondary outcome measures
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 moreAPPEAL 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
42 Previous Clinical Trials
9,627 Total Patients Enrolled
Hospital Sao LuizOTHER
Tallaght University HospitalOTHER
8 Previous Clinical Trials
622 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use a catheter regularly for urination.I have a urinary diversion in place.I am currently taking antibiotics for a UTI or another reason.You have a tube in your kidney.I need a bladder scope and stent placement on the same day as my shock wave therapy.I have had a severe urinary infection before undergoing a kidney stone procedure.You have had an allergic reaction to the antibiotic being used in the trial.Your urine test shows a high amount of bacteria, indicating a urinary tract infection.You have a type of kidney stone called struvite stone.Your urine test shows signs of a possible infection.I am over 18 and eligible for shock wave lithotripsy without any exclusions.
Research Study Groups:
This trial has the following groups:- Group 1: ciprofloxacin
- Group 2: Placebo
Awards:
This trial has 4 awards, including:- 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.
- 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 40 Other Conditions - This treatment demonstrated efficacy for 40 other conditions.
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.
What medical afflictions can Ciprofloxacin typically be prescribed to address?
"Ciprofloxacin is commonly used to address urinary tract infections caused by entercococcus faecalis. This antibiotic can also be employed in the management of other afflictions such as abdominal infection and pseudomonas aeruginosa."
Answered by AI
How many participants have enrolled in the trial thus far?
"Affirmative. Records on clinicaltrials.gov reveal that this medical study, which was first uploaded on September 27th 2018, is still recruiting participants. 1 site needs to enrol 1500 patients before the trial can be completed."
Answered by AI
Are there admissions available for this research endeavor?
"Per the information archived on clinicaltrials.gov, this trial is currently accepting participants with its last update occurring on October 8th 2021. This study was first advertised to potential patients on September 27th 2018."
Answered by AI
What additional research has been conducted regarding Ciprofloxacin?
"Currently, 26 clinical trials are examining the effects of Ciprofloxacin with 3 being in Phase 3. Many experiments for this drug are located Durham, North carolina; however, a total of 50 medical sites around the world have studies underway concerning Ciprofloxacin's efficacy."
Answered by AI
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