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Antibiotic
Culture-Directed vs Empiric Antibiotics for Urinary Tract Infections (REDUCTION Trial)
Phase 4
Recruiting
Research Sponsored by Megan Bradley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
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.
Who is the study for?
This trial is for biological female individuals aged 65 or older who have experienced more than two UTIs in the past six months or three in the last year. They must be able to report symptoms like pain, urgency, or increased frequency of urination. Those with severe liver disease, advanced kidney disease, dementia, high-dose steroid use, organ transplants, concerns for more serious infections like pyelonephritis/sepsis are excluded.
What is being tested?
The study is testing whether using antibiotics chosen based on culture results (culture-directed) is as effective as using a standard set of antibiotics (empiric) for treating urinary tract infection symptoms reported by older women.
What are the potential side effects?
Potential side effects from antibiotic use may include allergic reactions, gastrointestinal issues such as nausea and diarrhea, yeast infections due to disruption of normal body flora and possibly an increased risk of developing antibiotic resistance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of eligible participants that were enrolled in the study
Secondary study objectives
Monthly enrollment rate
Number of persons that were screened for participation
Proportion of enrolled participants that completed all study procedures
+6 moreSide effects data
From 2020 Phase 4 trial • 40 Patients • NCT0315975417%
Abscess and Drain Placement
13%
Drain Placement
8%
Nausea and vomiting
4%
Headache
4%
Testicular Swelling-hydrocele
4%
Admission for C-Diff
4%
ED Admission - Fever and Abdominal Pain
4%
Redness and discomfort around drain exit site
4%
Abdominal Pain
4%
Abscess, drainage without drain placement
4%
Ileus
4%
Persistent Abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
Early Appendectomy
Interval Appendectomy
No Appendectomy
Awards & Highlights
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Culture-directed antibioticExperimental Treatment1 Intervention
Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h.
Group II: Empiric antibioticActive Control1 Intervention
Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current IDSA guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antibiotics
2017
Completed Phase 4
~5180
Find a Location
Who is running the clinical trial?
Megan BradleyLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,762 Total Patients Enrolled
6 Trials studying Urinary Tract Infection
1,472 Patients Enrolled for Urinary Tract Infection
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Culture-directed antibiotic
- Group 2: Empiric antibiotic
Awards:
This trial has 3 awards, including:- 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.
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.
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