NCT07202949

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 evaluate their eligibility to participate in the trial. If eligible, participants will be randomly assigned into one of two groups: Group 1 will receive a treatment dose antibiotic in combination with the urinary antiseptic, methenamine hippurate (1 g twice daily). The treating clinician will select one of the following antibiotics based on the individual needs of the participant, such as their medical history, concomitant medications and any known allergies: * Cefalexin (500mg four times daily), or * Nitrofurantoin (100mg twice daily), or * Trimethoprim (200mg twice daily) Group 2 will receive a low-dose prophylactic antibiotic or the urinary antiseptic, methenamine hippurate. The treating clinician will select one of the following treatments based on the individual needs of the participant, such as their medical history, concomitant medications and any known allergies: * Amoxicillin (250mg once daily), or * Cefalexin (125mg once daily), or * Nitrofurantoin (50mg once daily), or * Trimethoprim (100mg once daily), or * Methenamine Hippurate (1g twice daily) Participants will be taking trial medication for 12 weeks and will be required to attend clinic for assessments every 4 weeks. Participant will complete questionnaires and provide blood, urine, and perineal (the area between the vagina and anus) swabs samples.

Conditions

• Chronic Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Treatment dose antibiotic in combination with methenamine hippurate	Arm A includes treatment with one of three treatment dose antibiotic options, selected by the treating clinician, in combination with methenamine hippurate. Participants allocated to this arm will receive combination therapy, consisting of one of the following antibiotics: * Cefalexin (500mg four times daily), or * Nitrofurantoin (100mg twice daily), or * Trimethoprim (200mg twice daily) in combination with Methenamine Hippurate (1g twice daily) for 12 weeks.
DRUG	Prophylactic dose antibiotic or methenamine hippurate monotherapy	Arm B includes treatment with one of four prophylactic dose antibiotics or methenamine hippurate, but not both, selected by the treating clinician. Participants in this arm will receive monotherapy of one of the following: * Amoxicillin (250mg once daily), or * Cefalexin (125mg once daily), or * Nitrofurantoin (50mg once daily), or * Trimethoprim (100mg once daily), or * Methenamine Hippurate (1g twice daily) for 12 weeks.

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-10-01
• Completion: 2027-11-01
• First posted: 2025-10-02
• Last updated: 2026-02-23

Locations

5 sites across 1 country: United Kingdom