Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
University College, London
Conditions:
Chronic Urinary Tract Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
EAT-UP is a UK multi-centre, randomised, open label, parallel-group, superiority, interventional phase II trial, aiming to recruit 192 female participants. Participants will undergo screening to evalu...
Eligibility Criteria
Inclusion
- 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/1.72m2.
- 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.
- A structural or functional abnormality may include kidney reflux, current or long-term catheter use, renal transplant, diversion surgery, renal stones, grade 3 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
- 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 (such as allergies, intolerances or concomitant medications).
- 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.
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT07202949
Start Date
December 1 2025
End Date
September 1 2027
Last Update
October 2 2025
Active Locations (5)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
2
University College London Hospitals NHS Foundation Trust
London, United Kingdom
3
Whittington Health NHS Trust
London, United Kingdom
4
Manchester University NHS Foundation Trust
Manchester, United Kingdom