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GT RACING: Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05652374
Collaborator
IBSA Institut Biochimique SA (Industry), Goodlife Pharma B.V. (Other)
100
Enrollment
1
Location
2
Arms
35.4
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The main objective of the study is to compare efficacy between hyaluronic acid - chondroitin sulphate (HA-CS) treatment and gold standard treatment (AB prophylaxis). Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.

Study population: Female (>18rs) with at least 3 symptomatic urinary tract infections (UTI's) in the previous year with no adequate curable therapeutic options.

Intervention: Intervention group (n=50): 50ml of sterile Ialuril (HA 1.6% CS 2%) weekly for 6 weeks, followed by monthly maintenance therapy for 1 year. Control group (n=50): oral nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 1 year. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.

During the study patients will fill-out questionnaires regarding symptoms, quality of life and use of healthcare. Furthermore urine will be collected at set timepoints.

Main study parameters/endpoints: The main study parameter is the number of UTI per patient-year. Secondary parameters are time to rUTI (wks.), outcome on the global responce assessment (GRA) scale, pattern of antibiotic resistance, outcome on the patient reported outcome questionnaire, cost effectiveness and Quality-of-life.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trial. Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.Randomized controlled trial. Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Actual Study Start Date :
Oct 20, 2022
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 1 year

Device: Ialuril 50ml Prefill
Bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 1 year
Other Names:
  • HA-CS

    		•
    Active Comparator: Control group

    nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 1 year. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.

    Drug: Nitrofurantoin
    100mg daily (1dd100mg or 2dd50mg) for 1 year. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)

    Outcome Measures

    Primary Outcome Measures

    1. Number of urinary tract infections [1 year]

      Number of urinary tract infections per patient-year

    Secondary Outcome Measures

    1. Time to first urinary tract infection [1 year]

      Time to first urinary tract infection

    2. Global Assessment of Improvement [7 weeks, 6 months and 12 months]

      Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best)

    3. Antibiotics resistance [Baseline, 6 months, 12 months]

      Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups

    4. Cost-effectiveness: medical consumption questionnaire [Baseline, 6 months, 12 months]

      Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire'

    5. Cost-effectiveness: productivity cost questionnaire [Baseline, 6 months, 12 months]

      Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'productivity cost questionnaire'

    6. Therapy specific patient reported outcomes (symptoms & bother) [baseline, 7 weeks, 6 months, 9 months, 12 months]

      Differences in therapy specific patient reported outcomes between both patient groups (measured in Therapy Specific Patient Reported Outcome (PRO) Questionnaire on Symptom & Bother rUTI & GAG therapy)

    7. General quality of life questionnaire (mobility, self-care, daily activities, pain/discomfort, anxiety/depression) [baseline, 7 weeks, 6 months, 9 months, 12 months]

      Is there a difference in the Quality-of-life between the 2 therapies during follow-up using ED-5D 5L questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboudumc Nijmegen Gelderland Netherlands 6525 GA

    Sponsors and Collaborators

    • Radboud University Medical Center
    • IBSA Institut Biochimique SA
    • Goodlife Pharma B.V.

    Investigators

    • Principal Investigator: Dick Janssen, MD, PhD, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05652374
    Other Study ID Numbers:
    • 111802
    • NL76892.091.21
    First Posted:
    Dec 15, 2022
    Last Update Posted:
    Dec 15, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Radboud University Medical Center
    GAG therapy
    Prophylactic antibiotics
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections
    Recurrence
    Nitrofurantoin

    Study Results

    No Results Posted as of Dec 15, 2022