Urinary Tract Infection, RecurrentPhase 1/2NCT06409819
Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
A Phase 1/2 study testing phage therapy in people with Urinary Tract Infection, Recurrent, run by University of California, San Diego at 1 site in United States.
Trial summary
This proposal will take an important first step in the study of phage therapy for treatment of recurrent urinary tract infection (rUTI) in female kidney transplant recipients (KTR); a common condition that is associated with increasing multidrug resistance, sickness, loss of kidney function and death. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infection, Recurrent
- What is being tested?
- phage therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2025to 1 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female kidney transplant recipients, aged 18 and older with a confirmed diagnosis of a history of recurring UTI with E. coli as their typical uropathogen.
- Two urine culture proven UTIs in prior 6 months or three in prior 12 months due to E coli. UTI is defined as any change in symptoms from baseline urinary comfort (dysuria, hematuria, abdominal/flank pain, increased urinary frequency) or systemic signs of infection (fever, chills, systemic inflammatory reaction syndrome etc.) associated with a positive urine culture with bacterial growth of ≥104 colony forming units/mL).
- Ability to self-administer study drug (or a family member that will do so) and willing to adhere to the phage therapy regimen.
- For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of phage therapy administration.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Presents with hardware in the urinary tract (e.g. stent, percutaneous nephrostomy, chronic urinary catheter).
- Recipient of >1 kidney transplant.
- Recipient of Ileal conduit.
- Recipient of surgical neobladder.
- Diagnosed with chronic urinary retention requiring self-catheterization.
- Anatomic cause for rUTI such as ureteral stenosis.
Show all 12Show fewer
- Within the first 3 months of kidney transplant.
- Venous access sites or in whom an existing venous access site needs to be preserved for future need (as per the participant's transplant nephrologist/ surgeon)
- Diagnosed with active cytomegalovirus or BK virus infections.
- Current pregnancy, actively trying to conceive, or lactating.
- Known allergic reactions to phage products.
- Prisoners or individuals without decisional capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92037
Saima Aslam, MD, 8586577643, saslam@health.ucsd.edu
About this study
Official title: Phase 1/ 2 Trial of Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
This proposal will take an important first step in the study of phage therapy for treatment of recurrent urinary tract infection (rUTI) in female kidney transplant recipients (KTR); a common condition that is associated with increasing multidrug resistance, sickness, loss of kidney function and death. The investigators will conduct a randomized phase I/II pilot clinical trial of targeted phage therapy versus placebo in asymptomatic female KTR with a history of rUTI due to Escherichia coli to assess safety, tolerability, and feasibility of this approach, possible efficacy, and changes in the gut and urinary microbiome during the 180 days of the study. This highly innovative and impactful proposal will provide proof of concept data and also inform the design of a subsequent larger phase III clinical trial of phage therapy for rUTI treatment in KTR and will have broad downstream effects within the fields of infectious diseases and transplantation.
Read the detailed description
The overarching hypothesis is that phage therapy directed against E. coli in female KTR is safe and associated with a reduction in UTI event rate via a targeted impact on the gut and urinary microbiome. This is a Phase 1/ 2 randomized, placebo-controlled clinical trial.
- A description of methods to be used to minimize bias Participants will be randomized to one of 2 arms - one active intervention phage therapy and the second is active intervention control arm (normal saline placebo). Participants will not be aware of study assignment and the medication delivered to them will look identical - clear 1mL solution in a plastic needless syringe.
- The number of study groups/arms and study intervention duration:
- Investigators plan to enroll participants that fulfill eligibility criteria until they reach their goal of 16 participants in each arm (total N= 32).
This clinical trial will evaluate the effect of phage only (without concomitant antibiotics) compared to placebo for UTI prevention in asymptomatic female KTR with a history of rUTI. There are no rigorous, published trials testing this approach, nor are there new therapeutics for rUTI in KTR on-market at this time. Most IND cases or trials compare phage plus antibiotic which limits the ability to isolate the contribution from phage to treatment success. The proposed research will utilize a phase I/II pilot trial designed to assess the safety, tolerability, and feasibility of therapy, compare potential efficacy, and assess changes to microbiome profiles in the female participants who will receive either phage or placebo. As the participants will be treated when they are asymptomatic, no active control is needed and so Investigators will use normal saline placebo.
- Conditions
- Urinary Tract Infection, Recurrent
- Being tested
- phage therapy, control
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phage therapyDrug
Also called targeted phage therapy
phage therapy will consist of a combination of three lytic phages that are active against the participant's E. coli isolates and will be administered intravenously twice daily for 7 days.
controlDrug
Also called placebo
Participants assigned to the control arm will start a 7-day course of intravenous sterile normal saline (placebo) administered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention phage therapy | Active comparator | 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. Receives: Drug: phage therapy |
| Intervention control arm (normal saline placebo) | Placebo comparator | 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. Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety of phage administration will be assessed by the incidence of adverse events (AE) as assessed by CTCAE v4.0. As this is a phase 1/ 2 pilot clinical study, the primary outcome is safety and tolerability of the IP.
Measured: 180 days
Enrollment Feasibility
Enrollment feasibility of the trial protocol will be assessed by enrollment and randomization (goal is ≥75% of target N at year 1 of the award).
Measured: 180 days
Proportion of participants with a phage match
Proportion of participants with a phage match will be assessed by the number of enrolled participants with a phage match (goal is ≥70%).
Measured: 180 days
Study Drug Adherence
Adherence to study drug administration by the participants (goal is ≥90%),
Measured: 180 days
Secondary outcomes (9)
Treatment Efficacy
Efficacy of the treatment as measured by the number of UTI events due to the original infecting pathogen over the 180-day study observation period (event rate), calculated for the intent to treat population. As this is a phase 1/ 2 trial, this outcome will give us an efficacy signal.
Measured: 180 days
Desirability of Outcome Rankings (DOOR) Score
A graded outcome based on clinical and microbiological parameters
Measured: 180 days
Proportion of Participants with UTI
The proportion of participants with UTI will be assessed.
Measured: 180 days
Days to first symptomatic UTI from the original infecting pathogen
The number of days to first symptomatic UTI from the original infecting pathogen will be assessed.
Measured: 180 days
Microbiological Eradication of Asymptomatic Bacteriuria
The microbiological eradication of asymptomatic bacteriuria will be assessed.
Measured: 180 days
Need for intravenous (IV) antibiotics
The need for IV antibiotics will be assessed.
Measured: 180 days
Number of days on antibiotics
The number of days on antibiotics will be assessed.
Measured: 180 days
Emergency room visit/ hospitalization due to UTI
Any occurrence of emergency room visit/ hospitalization due to UTI will be assessed.
Measured: 180 days
Change in kidney function from baseline to end of the study period
The change in kidney function from baseline to end of the study period will be assessed via serum creatinine, glomerular filtration rate, and occurrence of acute kidney injury.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start15 Jun 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection, RecurrentStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized to phage therapy or placebo in a 2:1 fashion. Participants will be blinded to study assignment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Saima Aslam, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409819
- Sponsor's protocol ID
- 809673
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/ 2 Trial of Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06409819
- Acronym / sponsor ID
- 809673
- Conditions
- Urinary Tract Infection, Recurrent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal will take an important first step in the study of phage therapy for treatment of recurrent urinary tract infection (rUTI) in female kidney transplant recipients (KTR); a common condition that is associated with increasing multidrug resistance, sickness, loss of kidney function and death. The investigators will conduct a randomized phase I/II pilot clinical trial of targeted phage therapy versus placebo in asymptomatic female KTR with a history of rUTI due to Escherichia coli to assess safety, tolerability, and feasibility of this approach, possible efficacy, and changes in the gut and urinary microbiome during the 180 days of the study. This highly innovative and impactful proposal will provide proof of concept data and also inform the design of a subsequent larger phase III clinical trial of phage therapy for rUTI treatment in KTR and will have broad downstream effects within the fields of infectious diseases and transplantation.
Detailed description
The overarching hypothesis is that phage therapy directed against E. coli in female KTR is safe and associated with a reduction in UTI event rate via a targeted impact on the gut and urinary microbiome. This is a Phase 1/ 2 randomized, placebo-controlled clinical trial.
- A description of methods to be used to minimize bias Participants will be randomized to one of 2 arms - one active intervention phage therapy and the second is active intervention control arm (normal saline placebo). Participants will not be aware of study assignment and the medication delivered to them will look identical - clear 1mL solution in a plastic needless syringe.
- The number of study groups/arms and study intervention duration:
- Investigators plan to enroll participants that fulfill eligibility criteria until they reach their goal of 16 participants in each arm (total N= 32).
This clinical trial will evaluate the effect of phage only (without concomitant antibiotics) compared to placebo for UTI prevention in asymptomatic female KTR with a history of rUTI. There are no rigorous, published trials testing this approach, nor are there new therapeutics for rUTI in KTR on-market at this time. Most IND cases or trials compare phage plus antibiotic which limits the ability to isolate the contribution from phage to treatment success. The proposed research will utilize a phase I/II pilot trial designed to assess the safety, tolerability, and feasibility of therapy, compare potential efficacy, and assess changes to microbiome profiles in the female participants who will receive either phage or placebo. As the participants will be treated when they are asymptomatic, no active control is needed and so Investigators will use normal saline placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized to phage therapy or placebo in a 2:1 fashion. Participants will be blinded to study assignment.
| Arm | Type | Receives |
|---|---|---|
| Intervention phage therapy | Active comparator | Drug: phage therapyClear 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. |
| Intervention control arm (normal saline placebo) | Placebo comparator | Drug: controlClear 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female kidney transplant recipients, aged 18 and older with a confirmed diagnosis of a history of recurring UTI with E. coli as their typical uropathogen.
- Two urine culture proven UTIs in prior 6 months or three in prior 12 months due to E coli. UTI is defined as any change in symptoms from baseline urinary comfort (dysuria, hematuria, abdominal/flank pain, increased urinary frequency) or systemic signs of infection (fever, chills, systemic inflammatory reaction syndrome etc.) associated with a positive urine culture with bacterial growth of ≥104 colony forming units/mL).
- Ability to self-administer study drug (or a family member that will do so) and willing to adhere to the phage therapy regimen.
- For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of phage therapy administration.
- Provision of signed and dated informed consent form
Key exclusion criteria (12 listed)
- Presents with hardware in the urinary tract (e.g. stent, percutaneous nephrostomy, chronic urinary catheter).
- Recipient of >1 kidney transplant.
- Recipient of Ileal conduit.
- Recipient of surgical neobladder.
- Diagnosed with chronic urinary retention requiring self-catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phage therapyAlso: targeted phage therapyphage therapy will consist of a combination of three lytic phages that are active against the participant's E. coli isolates and will be administered intravenously twice daily for 7 days. | Drug | Intervention phage therapy |
| controlAlso: placeboParticipants assigned to the control arm will start a 7-day course of intravenous sterile normal saline (placebo) administered twice daily. | Drug | Intervention control arm (normal saline placebo) |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 180 days
Safety of phage administration will be assessed by the incidence of adverse events (AE) as assessed by CTCAE v4.0. As this is a phase 1/ 2 pilot clinical study, the primary outcome is safety and tolerability of the IP.
Enrollment Feasibility
Time frame: 180 days
Enrollment feasibility of the trial protocol will be assessed by enrollment and randomization (goal is ≥75% of target N at year 1 of the award).
Proportion of participants with a phage match
Time frame: 180 days
Proportion of participants with a phage match will be assessed by the number of enrolled participants with a phage match (goal is ≥70%).
Study Drug Adherence
Time frame: 180 days
Adherence to study drug administration by the participants (goal is ≥90%),
9 secondary outcomes
Treatment Efficacy
Time frame: 180 days
Desirability of Outcome Rankings (DOOR) Score
Time frame: 180 days
Proportion of Participants with UTI
Time frame: 180 days
Days to first symptomatic UTI from the original infecting pathogen
Time frame: 180 days
Microbiological Eradication of Asymptomatic Bacteriuria
Time frame: 180 days
Need for intravenous (IV) antibiotics
Time frame: 180 days
Number of days on antibiotics
Time frame: 180 days
Emergency room visit/ hospitalization due to UTI
Time frame: 180 days
Change in kidney function from baseline to end of the study period
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing phage therapy in people with Urinary Tract Infection, Recurrent, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saima Aslam, M.D. ((619) 543-3108, rUTIphagestudy@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 180 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.