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Compares treatment options for Chronic Urinary Tract Infection
Official title 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
ClinicalTrials.gov ID: NCT07202949
What this study is testing
What is Treatment dose antibiotic in combination with methenamine hippurate?
Treatment dose antibiotic in combination with methenamine hippurate is an investigational medicine, given as an once-daily, being studied as a potential treatment for chronic urinary tract infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- A diagnosis of chronic UTI, without structural or functional urinary tract abnormality\ , defined as daily persistent symptoms affecting storage...
- 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.
You likely can't join if
- Inability to take at least one of the following antibiotics: Cefalexin, Nitrofurantoin, or Trimethoprim, at prophylactic and treatment dose according...
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- For the purposes of this trial, a female will be defined as an individual assigned female at birth who has a female urinary tract.
- 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...
- 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...
- Current participation in another clinical trial of a device, treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle upon Tyne, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom; Manchester, United Kingdom; Newcastle upon Tyne, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.