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Antibiotics for Kidney Stones
Study Summary
This trial will help researchers find the best antibiotic to treat kidney stones caused by bacteria.
- Kidney Stones
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You are expected to live for at least one more year.There are no restrictions based on age.You have had surgery to remove kidney stones, and there are no remaining stone pieces larger than 3mm.You have other health conditions that make it unsafe for you to have surgery.You still have kidney stones after having surgery to remove them.You have a stone in your body that is caused by an infection.You are expected to live for at least one more year.There is no age limit for participating in the study.
- Group 1: Arm B: 12 weeks/3 months Abx post PCNL
- Group 2: Arm A: 2 weeks Abx post PCNL
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
To what kind of medical issues is ciprofloxacin, cotrimoxazole-trimethoprim and macrodantin typically recommended as treatment?
"Ciprofloxacin, cotrimoxazole-trimethoprim and macrodantin are the most popular medications for treating otitis externa. These drugs have also been successful in managing urinary tract infections caused by entercococcus faecalis, bronchial infection and abdominal maladies."
Is enrollment in this trial still available?
"Affirmative. The clinicaltrials.gov database indicates that this investigation, which was first advertised on March 1st 2015 is actively recruiting participants. 28 individuals need to be enrolled across 12 different medical centres."
In which locations has this research been conducted?
"12 different medical sites are enlisting participants for this trial. These include Ohio State University in Athens, Mayo Clinic - Rochester, MN in Rochester, Vanderbilt University in Nashville and additional locations."
Have any of the drugs ciprofloxacin, cotrimoxazole-trimethoprim, and macrodantin been granted sanction by the FDA?
"Our team at Power assessed the safety of ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin to have a score of 3 due to it already being approved for use in Phase 4 trials."
Are there any comparable investigations that have employed ciprofloxacin, cotrimoxazole-trimethoprim and macrodantin?
"At this moment, 54 studies are underway that look into ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin; 9 of those have achieved Phase 3. San Diego is the epicentre for most of these trials but they can also be found at 124 distinct sites nationwide."
What is the cap on the number of individuals involved in this research project?
"This clinical trial seeks 28 participants that fulfill the eligibility requirements. Possible locations where patients might enrol in this research project are Ohio State University (Athens, OH) and Mayo Clinic - Rochester, MN (Rochester, Minnesota)."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Mayo Clinic - Scottsdale/Phoenix, AZ: < 48 hours
Typically responds via
Average response time
- < 2 Days
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