What side effects are associated with this type of intervention?

Common treatments for Urinary Tract Infections (UTIs) include antibiotics such as amoxicillin, ciprofloxacin, and trimethoprim-sulfamethoxazole. Known side effects of these antibiotics can include gastrointestinal issues (nausea, vomiting, diarrhea), allergic reactions, and, in some cases, more severe effects like hepatotoxicity or nephrotoxicity. Bacteriophage therapy, which uses viruses to target and kill bacteria, has shown minor side effects in studies, such as mild gastrointestinal discomfort. However, more extensive clinical trials are needed to fully understand its safety profile compared to traditional antibiotics.

What prior FDA approvals exist?

FDA-approved treatments for Urinary Tract Infections (UTIs) primarily include antibiotics such as ciprofloxacin, levofloxacin, and nitrofurantoin. These antibiotics target and kill the bacteria causing the infection. While bacteriophage therapy, which uses viruses to target and kill bacteria, is an emerging field, it has not yet received FDA approval for the treatment of UTIs. Current research and clinical trials, such as the one involving a 3-phage cocktail (HP3, HP3.1, and ES19), are exploring the potential of this innovative approach to treat drug-resistant UTIs.

What other types of research exist?

Promising novel alternatives to bacteriophage therapy for UTIs in 2024 include: 1) Immunotherapy approaches such as monoclonal antibodies targeting specific bacterial antigens. 2) Use of probiotics to restore healthy urinary microbiota and prevent infections. 3) Development of new antibiotics or antibiotic combinations that are effective against multidrug-resistant bacteria. 4) CRISPR-Cas systems designed to target and disrupt bacterial DNA. 5) Antimicrobial peptides that can kill bacteria by disrupting their cell membranes.

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Virus Therapy

Phage Therapy for Urinary Tract Infection

Phase 1 & 2

Waitlist Available

Led By Gregory German, MD PhD FRCPC

Research Sponsored by Gregory German

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of recurrent chronic urinary tract infections with severe long term effects

Be older than 18 years old

Must not have

Stage 5 chronic kidney disease

A urinary stent or chronic indwelling catheterization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a virus-based treatment to kill bacteria in a patient with a drug-resistant urinary tract infection. The treatment uses a mix of three specific viruses to target and destroy the bacteria causing the infection. The goal is to see if this approach is safe and effective in preventing the infection from coming back. Bacteriophage therapy has shown high effectiveness in treating bacterial infections, including UTIs, especially those caused by multidrug-resistant bacteria.

Who is the study for?

This trial is for English-speaking individuals with chronic, recurrent urinary tract infections that have serious long-term effects. Participants must be willing to follow the study protocol but cannot join if they have advanced kidney disease, abnormal liver tests, use a urinary stent or catheter regularly, are pregnant, part of another trial, or allergic to phage products.

What is being tested?

The trial is testing a new treatment called phage therapy using a cocktail of bacteriophages (viruses that target bacteria) named HP3, HP3.1 and ES19. It's given orally, topically into the urethra opening and directly into the bladder to treat drug-resistant UTI.

What are the potential side effects?

Potential side effects may include reactions at the application sites such as irritation or discomfort. Since this is an early-phase trial assessing safety and effectiveness of phage therapy for UTIs, detailed side effect profiles will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have chronic urinary tract infections with severe long-term effects.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is severely decreased.

Select...

I have a urinary stent or use a catheter regularly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Tolerability

Secondary study objectives

Clinical and microbial response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open Label ArmExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Urinary Tract Infections (UTIs) include antibiotics and bacteriophage therapy. Antibiotics work by targeting specific bacterial functions, such as cell wall synthesis or protein production, effectively killing the bacteria causing the infection. Bacteriophage therapy, on the other hand, uses viruses that specifically infect and lyse bacterial cells, offering a targeted approach to eliminate the infection. Understanding these mechanisms is crucial for UTI patients as it highlights the importance of selecting the appropriate treatment to effectively eradicate the infection and prevent recurrence.