EAT-UP - Extended Antibiotic Treatment in Chronic UTI Patients; a Phase II Safety and Efficacy Trial
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).
• 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.
⁃ 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.