Extended high-dose antibiotics plus methenamine hippurate versus standard low-dose antibiotics or methenamine hippurate for women with chronic urinary tract infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

EAT-UP is a UK, multi-centre, randomized, open-label phase II trial enrolling 192 adult female participants with chronic urinary tract infection. Participants are randomly assigned to two arms: a high (treatment) dose antibiotic chosen by the clinician plus methenamine hippurate, or a standard low-dose prophylactic antibiotic or methenamine hippurate alone. Medications are taken for 12 weeks with clinic visits and assessments every four weeks, and participants provide questionnaires and blood, urine, and perineal samples. The trial focuses on symptom reduction and tolerability in people with persistent daily urinary symptoms and evidence of urinary inflammation on microscopy.

Why it matters

Who can join: the full rules

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 within the screening period.
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.

Where it's running

• University College London Hospital (UCLH), UCLH NHS Foundation Trust
  London, United Kingdom Recruiting
• Whittington Hospital, Whittington Health NHS Trust
  London, United Kingdom Recruiting
• St Mary's Hospital, Manchester University NHS Foundation Trust
  Manchester, United Kingdom Recruiting
• Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
  Newcastle upon Tyne, United Kingdom Recruiting
• Scunthorpe General Hospital and Diana, Princess of Wales Hospital ; Northern Lincolnshire and Goole NHS Foundation Trust
  Yorkshire, Humber, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: EAT-UP Trial Team
• Email: cctu.eat-up@ucl.ac.uk
• Phone: 020 3108 5298

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.