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Culture-Directed vs Empiric Antibiotics for Urinary Tract Infections (REDUCTION Trial)
REDUCTION Trial Summary
This trial will assess if a culture-based or empiric antibiotic strategy is best for treating UTI symptoms in older women, and their ability to follow the study plan.
REDUCTION Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 40 Patients • NCT03159754REDUCTION Trial Design
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- I have severe liver disease or cirrhosis.I have had a solid organ transplant.I am 65 years old or older.My doctor is concerned I might have a kidney infection or sepsis.I have dementia or live in a skilled nursing facility.I am taking more than 20mg/day of prednisone.I am biologically female.My kidney function is reduced with a filtration rate below 50 ml/min.I have symptoms of a UTI, like pain when peeing or needing to pee more often.I am biologically male.I am younger than 65 years old.I have had more than 2 UTIs in the last 6 months or 3 in the last year.I have had bladder enlargement or removal surgery.I currently use a permanent urinary catheter.I use a catheter by myself to empty my bladder.I have had a procedure on my urinary tract in the last 30 days.I am currently receiving treatment for cancer.I have had a kidney infection or severe urinary tract infection.
- Group 1: Culture-directed antibiotic
- Group 2: Empiric antibiotic
- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Has Empiric antibiotic been accepted by the FDA?
"Through our evaluation, the safety of empiric antibiotics was determined to be a 3--indicating approval status due its Phase 4 standing."
What is the current scope of participants in this experiment?
"Affirmative, clinicaltrials.gov data reveals that this medical trial is actively recruiting volunteers. The initial posting date was February 1st 2023 and the most recent edit took place on February 3rd 2023. 70 participants are required to be enrolled across a single site."
Is there an open enrollment period for this medical research?
"Affirmative. Clinicaltrials.gov evidences this clinical trial is still in search of applicants, with an initial posting date of February 1st 2023 and a recent update on February 3rd 2023. The aim is to recruit 70 participants from one site."
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