Primary objective: The primary objective of this study is to investigate if taking methenamine hippurate reduce the need for antibiotic usage due to recurrent UTI (measured as the number of courses of antibiotics).Secondary objectives:to investigate…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of UTI courses during day 2-180 for which antibiotics were prescribed
Secondary outcome
Number of UTI courses in the period up to 6 months after discontinuation of
methenamine
Number of UTI during methenamine
Severity of UTI symptoms
Duration of UTI episodes
Number of complications such as pyelonephritis and hospital admission for UTI
Background summary
There is a need for a large well-conducted randomised controlled trial (RCT) to
clarify both the safety and preventive effect of methenamine hippurate on
urinary tract infections for longer term use.
Study objective
Primary objective: The primary objective of this study is to investigate if
taking methenamine hippurate reduce the need for antibiotic usage due to
recurrent UTI (measured as the number of courses of antibiotics).
Secondary objectives:
to investigate if methenamine hippurate will have a prolonged effect on
antibiotic usage even after discontinuation
to investigate if taking methenamine hippurate reduces the incidence of UTI
to investigate if methenamine hippurate can reduce severity of UTI symptoms
to investigate if methenamine hippurate can reduce duration of UTI episodes
to investigate if number of complications such as pyelonephritis and hospital
admission for UTI differ between methenamine hippurate and placebo.
Study design
Blinded randomised controlled phase IV trial where patients are randomised to
active intervention (methenamine hippurate) or controls (placebo).
Intervention
Methenamine hippurate vs placebo
Study burden and risks
Potential benefits from IMP:
* decreased total use of UTI antibiotics
* reduced antibiotic pressure on gut microbiota in the population and possibly
reduced antimicrobial resistance (AMR) in the population
* decreased number of UTIs
* increased quality of life.
Potential risks from IMP:
* polypharmacy, many patients have a large number of regular medication, and
methenamine hippurate will be a new one for six months
* simultaneous intake of sulphonamide antibiotics can increase risk of
crystalluria. Therefore methenamine hippurate will temporarily be paused if the
participant gets a course of sulphonamide antibiotics . There are no other
known clinical relevant interactions between methenamine hippurate and other
pharmaceuticals.
Anticipated adverse drug reactions in the study:
Methenamine hippurate is well tolerated and adverse effects are rare and
generally mild. Possible side effects might be minor gastrointestinal upsets,
dysuria (seldom), abdominal cramps, anorexia, rash and stomatitis. The trial
team will be available on telephone for urgent cases during the whole study
period.
Risk/benefit rationale:
* The benefit of the study is potentially great for elderly women with
recurrent UTI resulting in fewer UTI episodes, reduced antibiotic usage and
therefore also reducing the risk of AMR.
* The risk of the study is considered to be very small.
In summary the benefits greatly outweigh the potential small risk.
Problemveien 7
oslo 0315
NL
Problemveien 7
oslo 0315
NL
Listed location countries
Age
Inclusion criteria
• woman
• age >= 70 years
• recurrent UTIs defined as >= 3 episodes of antibiotic treated acute cystitis
(acute symptoms specific/related to the urinary tract) during the last twelve
months or >= 2 episodes during the last 6 months
• able and willing to comply with all trial requirements
• able and willing to give informed consent
Exclusion criteria
• the patient has taken methenamine hippurate within the last 12 months
• the patient is allergic to methenamine hippurate
• the patient is having current antibiotic prophylaxis for UTI
• the patient has a urinary catheter (chronic indwelling catheters as well as
intermittent urinary catheterisation)
• the patient has known severe chronic renal failure or estimated creatinine
glomerular filtration rate <= 30 ml/min (known = registered in GP* clinical
records)
• the patient has a known condition or treatment associated with significant
impaired immunity (e.g. long-term oral steroids, chemotherapy, or immune
disorder) (known = registered in GP clinical records)
• the patient has a known severe hepatic impairment (known = registered in GP
clinical records)
• the patient is suffering from severe dehydration
• the patient has gout
• the patient has a need for long term use of antacids such as magnesium
hydroxide, magnesium carbonate, aluminium hydroxide
• the patient has a life expectancy estimated by a clinician to be less than
six months
• the patient has been involved in, including completion of, follow-up
procedures, in another clinical trial of an investigational medicinal product
in the last 90 days
• the patient suffers from incontinence too severe to be able to provide a
voided urine specimen
• the patient is participating in ImpresU Work Package 2
• the patient is suffering from significant known abnormal renal tract
anatomy/physiology or neuropathic bladder disorders.
• lactose intolerance
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002235-15-NL |
| ClinicalTrials.gov | NCT04077580 |
| CCMO | NL71512.041.19 |