90 Participants NeededMy employer runs this trial

Antibiotics for Urinary Tract Infection

(GUIDE-UTI Trial)

MS
Overseen ByMegan S Bradley, MD MSc
Age: 65+
Sex: Female
Trial Phase: Phase 3
Sponsor: Megan Bradley
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat urinary tract infections (UTIs) in older women by comparing three antibiotic strategies. Researchers aim to determine who benefits most from immediate antibiotics, waiting for urinalysis results, or waiting for a more detailed urine culture before treatment. The goal is to improve symptom relief and quality of life while using antibiotics wisely. Women over 65 who have experienced frequent UTIs in the past year, with symptoms like painful urination or frequent urges, might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that antibiotics for urinary tract infections (UTIs) are generally safe for most people. Studies have found that oral β-lactams, a common antibiotic, succeed in over 90% of immediate treatment cases, indicating effectiveness for many patients. However, treatment might fail, particularly in older adults or those with conditions like diabetes.

For culture-based treatment, evidence suggests that waiting for results before starting antibiotics can reduce unnecessary use, helping to avoid side effects such as stomach upset or allergic reactions.

Waiting for urinalysis results before starting antibiotics can also reduce antibiotic use and side effects. However, delaying antibiotics might worsen outcomes if the infection is severe.

In summary, antibiotics for UTIs are usually safe and effective, though risks exist, especially with immediate treatment in older adults. Waiting for test results can minimize unnecessary use and side effects, but immediate treatment might be necessary for severe cases. Always discuss the best option with a healthcare provider.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores different strategies for prescribing antibiotics for urinary tract infections (UTIs). Unlike the standard approach, which often involves immediately prescribing antibiotics, this trial includes methods like culture-directed and urinalysis-directed treatments. These innovative approaches delay antibiotic use until test results are available, potentially reducing unnecessary antibiotic exposure and combating antibiotic resistance. This could lead to more personalized and effective treatments for UTIs, aligning antibiotic use with patients' specific needs.

What evidence suggests that this trial's treatments could be effective for urinary tract infections?

Research has shown that starting antibiotics immediately based on experience and guidelines, known as empiric treatment, can be effective but has some downsides. In this trial, participants in the empiric antibiotic treatment arm will receive antibiotics right away. Observational studies found that 12 to 16% of patients treated this way for simple urinary tract infections (UTIs) experienced symptom recurrence within a month.

Another arm of this trial involves culture-directed treatment, where lab tests identify the bacteria to select antibiotics, which is considered more accurate. Participants in this arm will wait to take antibiotics until urine culture results are available.

The trial also includes a urinalysis-directed treatment arm, where participants will wait for quick urine test results to guide antibiotic choice. Studies support this method, showing it can quickly help select the right drug. Both culture and urinalysis methods aim to reduce unnecessary antibiotic use and more accurately target the infection.678910

Who Is on the Research Team?

MB

Megan Bradley, MD, MSc

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for older women who have urinary tract symptoms. It aims to find the best way to manage these symptoms and determine when antibiotics are truly needed.

Inclusion Criteria

I was born biologically female.
I am 65 years old or older.
I have had multiple urinary tract infections in the past year.
See 1 more

Exclusion Criteria

Previous solid organ transplant
I have had a urinary tract procedure in the past 30 days.
I was assigned male at birth.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three treatment strategies: empiric antibiotics, urinalysis-guided therapy, or culture-directed care, and followed for 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical success at 14 days and secondary outcomes at 30 days

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Antibiotics

Trial Overview

The study compares three ways of treating urinary tract symptoms: giving antibiotics right away, using urine tests to guide treatment, or waiting for lab cultures before deciding on care. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Urinalysis-directed Antibiotic TreatmentExperimental Treatment1 Intervention
Group II: Empiric (Immediate) Antibiotic TreatmentExperimental Treatment1 Intervention
Group III: Culture-directed Antibiotic TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Megan Bradley

Lead Sponsor

Trials
2
Recruited
90+

American Association of Obstetricians and Gynecologists Foundation (AAOGF)

Collaborator

Citations

Effectiveness

In medicine, effectiveness relates to how well a treatment works in practice, especially as shown in pragmatic clinical trials, as opposed to efficacy,

Find Legislators

Center for Effective Lawmaking provided by the Center for the Study of Democratic Institutions

Institutional Effectiveness Partnership Initiative

The Institutional Effectiveness and Partnership Initiative (IEPI) was launched in 2014 to help California's community colleges and college districts improve ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/11869658/

Condom effectiveness in reducing heterosexual HIV ...

This review indicates that consistent use of condoms results in 80% reduction in HIV incidence. Consistent use is defined as using a condom for all acts of ...

Evaluation Criteria

The OECD has defined six evaluation criteria – relevance, coherence, effectiveness, efficiency, impact and sustainability – and two principles for their use.

Antibiotic prophylaxis for urinary tract infections after ...

antibiotic prophylaxis was associated with benefit to the patient, with an absolute reduction in risk of urinary tract infection of 5.8% ...

Antibiotic Stewardship in the Emergency Department ...

In a recent study of pediatric patients discharged from the ED, antibiotics were discontinued in only 4 cases of 25 presumptively treated UTIs ...

original article - impact of a urine culture follow-up program ...

4. A study in France focusing on UTIs in the pediatric population showed that antibiotic exposure in the 12 months preceding a UTI diagnosis was associated with ...

Antibiotics and Their Impact on Urine Culture Test Accuracy

If you are on antibiotics before the test, the bacteria may not grow in the culture, leading to a false negative. To ensure accurate results and avoid ...

Prediction of Antibiotic Susceptibility for Urinary Tract Infection ...

We used electronic health record data to create predictive models to estimate antibiotic susceptibilities for urinary tract infections in ...