New hope for chronic UTI sufferers: extended antibiotic combo trial launches

NCT ID NCT07202949

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This phase II trial tests whether a 12-week course of higher-dose antibiotics combined with a urinary antiseptic (methenamine hippurate) can better control chronic UTI than standard low-dose antibiotics or antiseptic alone. About 192 adults with daily UTI symptoms for at least 3 months will be enrolled. The main goal is to see if this approach reduces bladder inflammation and improves symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Antibiotics (cefalexin, nitrofurantoin, or trimethoprim) combined with methenamine hippurate
What this could lead to
If successful, this could provide a more effective treatment option for people with chronic UTI, reducing persistent symptoms and improving quality of life.
What could go wrong
This is a mid-stage trial with only 192 participants, so results may not apply to everyone. Antibiotics can cause side effects like gut issues or resistance, and the combination may not work better than current treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. A diagnosis of chronic UTI, without structural or functional urinary tract abnormality\*, defined as daily persistent symptoms affecting storage (urinary frequency, urgency or urge incontinence) and urinary tract pain symptoms (including bladder pain, urethral pain, or dysuria), for at least 3 months prior to the screening visit, with previously associated transient symptomatic improvement to antibiotic treatment for UTI, which in the opinion of the delegated clinician is secondary to chronic urinary tract infection. 2. A fresh urine microscopy examination showing ≥20 white blood cells/µl of urine at the screening visit. 3. Female\*\* patients. 4. Aged ≥18 years. 5. Screening blood result of eGFR ≥45ml/min/1.73m2. 6. Able and willing to attend trial visits and comply with all study procedures for the duration of the trial. 7. Able and willing to provide informed consent prior to any study related assessments and/or procedures. * A structural or functional abnormality may include kidney reflux, current or long-term catheter use, renal transplant, diversion surgery, renal stones, grade 2 or above utero-vaginal prolapse or incomplete bladder emptying. * For the purposes of this trial, a female will be defined as an individual assigned female at birth who has a female urinary tract. Exclusion Criteria: 1. Inability to take at least one of the following antibiotics: Cefalexin, Nitrofurantoin, or Trimethoprim, at prophylactic and treatment dose according to NICE guidelines, and/or the Summary of Product Characteristics (such as hepatic or renal dysfunction), or any other medical contraindications. 2. Inability to take methenamine hippurate due to medical contraindications. 3. Current use of immune-modulating drugs for the treatment of chronic illnesses such as rheumatoid arthritis, chronic lung disease, any other autoimmune conditions or cancer. 4. Current use of Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors\*. 5. A current diagnosis of bladder cancer. 6. A diagnosis of an active sexually transmitted infection or a recent diagnosis of a sexually transmitted infection within the last 3 months of the screening visit. 7. Previous use of an antibiotic at treatment dose as per NICE guidelines for more than 14 consecutive days for treatment of UTI in the last 3 months prior to the screening visit. 8. Pregnancy (or planned pregnancy during trial participation) and/or breastfeeding. 9. Women of childbearing potential that are unable/unwilling to use an acceptable method of contraception (as described in section 3.4.1) to avoid pregnancy for the duration of the trial and for 1 week after the last dose of trial medication. 10. Current participation in another clinical trial of a device, interventional medicinal product, advanced therapy, or surgical procedure; or previous participation within 6 months of the screening visit. 11. Any medical condition or previous treatment which in the investigator's opinion compromises the potential participant's ability to participate. * Patient's must not have taken a Sodium-Glucose Transport Protein 2 (SGLT2) inhibitor within 24 hours before the screening visits to be eligible for the trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • St Mary's Hospital, Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, United Kingdom

  • University College London Hospital (UCLH), UCLH NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Whittington Hospital, Whittington Health NHS Trust

    RECRUITING

    London, United Kingdom