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NCT05652374
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Conditions: Recurrent Urinary Tract Infection
Sex: Female
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 100
Sponsor: Radboud University Medical Center
Location: Netherlands
Summary
The GT RACING is a study comparing the efficacy of HA-CS bladder installations with prophylactic antibiotics in the prevention of recurrent urinary tract infections (rUTI).
Eligibility Criteria
Inclusion Criteria:Adult female patients (>18 years) who had at least 3 symptomatic UTI's in the previous year with no adequate curable therapeutic options (e.g.
bladder stones)At least one UTI's must be confirmed with a positive culture and antibiogram, further UTI's must be confirmed with a urine sediment with positive nitrite or a positive culture.Exclusion Criteria:Male< 18 yearsPregnantAlready on GAG therapyAlready on prophylactic antibioticsStarted or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two monthsHad Gentamicin or other antibiotic instillations in the previous 2 monthsAllergic to >3 regular used antibiotics in Dutch guidelines (ed.
Nitrofurantoin, trimethoprim, Fosfomycin)A urinary fistulaUrinary stonesUrogenital cancerBladder Pain Syndrome - Interstitial CystitisChronic pelvic painHad a STD untreated or treated in the previous 2 monthsA urinary diversionAn Indwelling catheterA suprapubic catheterPerforming >1/day self-catheterizationA residue after voiding (PVR) of >200mlUnable (also legal) to give informed consentRecurrent urosepsisMultiresistant bacteria in previous urine culturesContra-indications and interactions for Nitrofurantoin: severe kidney disfunction (GFR < 30), lung- or liver problems or neuropathy after previous use of nitrofurantoin, acute porphyria, known G6PD deficiency, use of magnesium trisilicate.Contra-indications and interactions for trimethoprim: severe kidney or liver dysfunction, blood count abnormality, use of vitamin K antagonists, use of folic acid antagonists, use of ace inhibitorsSevere lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD)Does not tolerate catheterization
Source: ClinicalTrials.gov (NCT05652374). StuddyBuddy aggregates publicly available trial information.