NCT05652374 Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
| NCT ID | NCT05652374 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Radboud University Medical Center |
| Condition | Recurrent Urinary Tract Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-20 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-10-20 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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: 1. 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) 2. 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: 1. Male 2. \< 18 years 3. Pregnant 4. Already on GAG therapy 5. Already on prophylactic antibiotics 6. Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months 7. Had Gentamicin or other antibiotic instillations in the previous 2 months 8. Allergic to \>3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin) 9. A urinary fistula 10. Urinary stones 11. Urogenital cancer 12. Bladder Pain Syndrome - Interstitial Cystitis 13. Chronic pelvic pain 14. Had a STD untreated or treated in the previous 2 months 15. A urinary diversion 16. An Indwelling catheter 17. A suprapubic catheter 18. Performing \>1/day self-catheterization 19. A residue after voiding (PVR) of \>200ml 20. Unable (also legal) to give informed consent 21. Recurrent urosepsis 22. Multiresistant bacteria in previous urine cultures 23. 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. 24. 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 25. Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD) 26. Does not tolerate catheterization
Contact & Investigator
Dick Janssen, MD, PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT05652374 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Recurrent Urinary Tract Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05652374 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05652374 currently recruiting?
Yes, NCT05652374 is actively recruiting participants. Contact the research team at dick.janssen@radboudumc.nl for enrollment information.
Where is the NCT05652374 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Arnhem, Netherlands, Nijmegen, Netherlands.
Who is sponsoring the NCT05652374 clinical trial?
NCT05652374 is sponsored by Radboud University Medical Center. The principal investigator is Dick Janssen, MD, PhD at Radboud University Medical Center. The trial plans to enroll 100 participants.