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NOT YET RECRUITING
NCT07202949
PHASE2

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

Sponsor: University College, London

View on ClinicalTrials.gov

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).

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2026-02-28

Completion Date

2027-11

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

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.

Locations (5)

Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

University College London Hospital (UCLH), UCLH NHS Foundation Trust

London, United Kingdom

Whittington Hospital, Whittington Health NHS Trust

London, United Kingdom

St Mary's Hospital, Manchester University NHS Foundation Trust

Manchester, United Kingdom

Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom