Phage Therapy for Recurrent UTIs

Overseen By Saima Aslam, M.D.

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Diego

Disqualifiers: Urinary hardware, Multiple transplants, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether phage therapy can safely and effectively treat recurring urinary tract infections (UTIs) in female kidney transplant recipients. Phage therapy uses viruses that specifically target harmful bacteria, such as Escherichia coli, which often cause these infections. Participants will receive either the phage treatment or a placebo to compare outcomes over 180 days. Women who have experienced two or more E. coli UTIs in the past six months or three in the past year and have had a kidney transplant might be suitable candidates for this trial. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that phage therapy is likely to be safe for humans?

Research has shown that phage therapy might help treat urinary tract infections (UTIs). In previous studies, many patients experienced positive outcomes. However, phage therapy remains new and lacks full approval in the U.S. Researchers are currently assessing its safety and tolerability.

One study examined the safety of using bacteriophages, viruses that attack bacteria. Patients with recurring UTIs generally tolerated them well, with most experiencing no serious side effects.

Since this trial is in an early stage, it primarily focuses on safety and tolerability. Researchers closely monitor patient reactions and any negative effects. So far, evidence suggests that phage therapy could be safe, but further research is necessary to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for recurrent UTIs?

Researchers are excited about phage therapy for recurrent UTIs because it uses bacteriophages, which are viruses that specifically target and kill bacteria. Unlike standard treatments like antibiotics, phage therapy can be highly specific, potentially reducing the risk of disrupting beneficial bacteria in the body and minimizing side effects. Additionally, phage therapy offers a novel approach to combat antibiotic-resistant bacteria, which is a growing concern with current treatments. This targeted action and potential to address antibiotic resistance make phage therapy a promising alternative for treating recurrent UTIs.

What evidence suggests that phage therapy might be an effective treatment for recurrent UTIs?

Research has shown that phage therapy, which participants in this trial may receive, could be a promising treatment for urinary tract infections (UTIs). A review found that over 72% of studies reported positive results both clinically and in lab tests. However, one study found that only 18% of patients improved after 7 days of treatment. Phage therapy uses viruses that specifically target and kill bacteria, such as Escherichia coli, which often cause UTIs. While results can vary, this treatment is considered innovative, especially for infections that don't respond to common antibiotics. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for female kidney transplant recipients over 18 with a history of recurrent UTIs caused by E. coli or K. pneumoniae. Participants must be able to self-administer the study drug or have someone who can do it for them, agree to use effective contraception if they can become pregnant, and commit to the study's duration.

Inclusion Criteria

I've had multiple UTIs caused by E. coli or K. pneumoniae in the last year.

I am willing and able to follow all study rules and attend all appointments.

I can take my medication by myself or have someone who can help me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either phage therapy or placebo for UTI prevention

1 week

Daily visits for IV administration

Follow-up

Participants are monitored for safety, tolerability, and efficacy of the treatment

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Phage Therapy

Trial Overview The trial is testing phage therapy versus placebo in women with kidney transplants who frequently get UTIs. It aims to check safety, tolerability, feasibility, potential effectiveness, and how it affects gut and urinary microbiomes over a period of 180 days.

How Is the Trial Designed?

Group I: Intervention phage therapy Active Control 1 Intervention

Clear 1 milliliter (ml) solution in a plastic needless syringe. Phage therapy will consist of twice daily intravenous (IV) dose of previously selected phage combination of at least 109 plaque forming units (PFU)/ ml concentration per phage but not to exceed 5EU/Kg/hr of total lipopolysaccharide endotoxin for the entire dose as per FDA guidelines.

Group II: Intervention control arm (normal saline placebo) Placebo Group 1 Intervention

Clear 1mL solution in a plastic needless syringe. Placebo will consist of IV normal saline administered in the same manner as the active comparator for 7 days.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10523411/

Phage Therapy in the Management of Urinary Tract Infections The results of this review suggest that phage therapy for UTIs can be effective; more than 72% of the included articles reported microbiological and clinical ...

2. eu-focus.europeanurology.com eu-focus.europeanurology.com/article/S2405-4569(24)00126-3/fulltext

Innovations in Phage Therapy for Urinary Tract Infection . This trial reported treatment success (combined microbiological and clinical treatment response after 7 days) in only 18% (five of 28) of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05537519

Phage Therapy for the Treatment of Urinary Tract Infection The primary objective is to determine the safety and tolerability of minimally invasive bacteriophage therapy for treating recurrent urinary tract infections ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12356746/

Phage Therapy for Urinary Tract Infections Although there are numerous reports of positive outcomes for UTI patients after phage therapy [48], critical evaluation of these reports is ...

5. journals.asm.org journals.asm.org/doi/10.1128/aac.00037-23

Therapeutic Potential of Intravenous Phage as Standalone ... Phage therapy related microbial succession associated with successful clinical outcome for a recurrent urinary tract infection. Viruses 13:2049.

6. liveutifree.com liveutifree.com/phage-therapy/

Phage Therapy For Recurrent UTIs But it's important to note that phage therapy is still under research in the U.S. and is not clinically validated. This is primarily due to a ...