A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hi… (NCT07202949) | Clinical Trial Compass
RecruitingPhase 2
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
United Kingdom192 participantsStarted 2026-02-26
Plain-language summary
Chronic Urinary Tract Infection (UTI) is a type of UTI where symptoms are constant and occur every day, unlike recurrent UTIs, which come and go with symptom-free breaks in between. Current treatment for chronic UTI within the NHS is based on recommended guidelines for recurrent UTI. The standard approach typically includes one of the following treatments:
* Long-term, prophylactic (low) dose daily antibiotic (where medication is used at low doses to try to prevent symptoms reoccurring).
* Long-term use of a urinary antiseptic (which helps keep your urine bacteria free), called methenamine hippurate.
These often do not work for people with chronic UTI, and symptoms can persist. Moreover, standard urine tests may fail to detect infections, making diagnosis and treatment more challenging.
The EAT-UP trial will investigate whether longer courses of treatment (higher) dose antibiotics combined with methenamine hippurate (a urinary antiseptic) are a more effective treatment at reducing levels of infection and symptoms than standard of care treatments (as described above).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. A fresh urine microscopy examination showing ≥20 white blood cells/µl of urine at the screening visit.
✓. Female\*\* patients.
✓. Aged ≥18 years.
✓. Screening blood result of eGFR ≥45ml/min/1.73m2.
✓. Able and willing to attend trial visits and comply with all study procedures for the duration of the trial.
✓. Able and willing to provide informed consent prior to any study related assessments and/or procedures.
Exclusion criteria
✕
What they're measuring
1
Change in urinary white blood cell (WBC) count from baseline to Week 12.
. 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.
✕. Inability to take methenamine hippurate due to medical contraindications.
✕. 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.
✕. Current use of Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors\*.
✕. A current diagnosis of bladder cancer.
✕. 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.
✕. 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.
✕. Pregnancy (or planned pregnancy during trial participation) and/or breastfeeding.