Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Recruiting now · Phase 4
Conditions studied: Recurrent Urinary Tract Infection
In brief
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).
Key facts
- Study ID
- NCT05652374
- Run by
- Radboud University Medical Center
- People needed
- 100
- Starts
- 2022-10-20
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2024-11-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Male
- < 18 years
- Pregnant
- Already on GAG therapy
- Already on prophylactic antibiotics
- Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months
- Had Gentamicin or other antibiotic instillations in the previous 2 months
- Allergic to >3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin)
- A urinary fistula
- Urinary stones
- Urogenital cancer
- Bladder Pain Syndrome - Interstitial Cystitis
- Chronic pelvic pain
- Had a STD untreated or treated in the previous 2 months
- A urinary diversion
- An Indwelling catheter
- A suprapubic catheter
- Performing >1/day self-catheterization
- A residue after voiding (PVR) of >200ml
- Unable (also legal) to give informed consent
- Recurrent urosepsis
- Multiresistant bacteria in previous urine cultures
- Contra-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 inhibitors
- Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD)
Where it is running
- Radboudumc — Nijmegen, Gelderland, Netherlands (enrolling)
- Rijnstate ziekenhuis — Arnhem, Netherlands (enrolling)
- Canisius wilhelmina ziekenhuis — Nijmegen, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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