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

Primary Purpose

Recurrent Urinary Tract Infection

Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Ialuril 50ml Prefill
Nitrofurantoin
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Urinary Tract Infection focused on measuring GAG therapy, Prophylactic antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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) Does not tolerate catheterization

Sites / Locations

  • RadboudumcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of urinary tract infections
Number of urinary tract infections per patient-year

Secondary Outcome Measures

Time to first urinary tract infection
Time to first urinary tract infection
Global Assessment of Improvement
Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best)
Antibiotics resistance
Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups
Cost-effectiveness: medical consumption questionnaire
Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire'
Cost-effectiveness: productivity cost questionnaire
Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'productivity cost questionnaire'
Therapy specific patient reported outcomes (symptoms & bother)
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)
General quality of life questionnaire (mobility, self-care, daily activities, pain/discomfort, anxiety/depression)
Is there a difference in the Quality-of-life between the 2 therapies during follow-up using ED-5D 5L questionnaire

Full Information

First Posted
November 23, 2022
Last Updated
December 14, 2022
Sponsor
Radboud University Medical Center
Collaborators
IBSA Institut Biochimique SA, Goodlife Pharma B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05652374
Brief Title
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Acronym
GT RACING
Official Title
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
IBSA Institut Biochimique SA, Goodlife Pharma B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
GAG therapy, Prophylactic antibiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial. Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 1 year
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 1 year. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.
Intervention Type
Device
Intervention Name(s)
Ialuril 50ml Prefill
Other Intervention Name(s)
HA-CS
Intervention Description
Bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 1 year
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Intervention Description
100mg daily (1dd100mg or 2dd50mg) for 1 year. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)
Primary Outcome Measure Information:
Title
Number of urinary tract infections
Description
Number of urinary tract infections per patient-year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to first urinary tract infection
Description
Time to first urinary tract infection
Time Frame
1 year
Title
Global Assessment of Improvement
Description
Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best)
Time Frame
7 weeks, 6 months and 12 months
Title
Antibiotics resistance
Description
Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups
Time Frame
Baseline, 6 months, 12 months
Title
Cost-effectiveness: medical consumption questionnaire
Description
Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire'
Time Frame
Baseline, 6 months, 12 months
Title
Cost-effectiveness: productivity cost questionnaire
Description
Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'productivity cost questionnaire'
Time Frame
Baseline, 6 months, 12 months
Title
Therapy specific patient reported outcomes (symptoms & bother)
Description
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)
Time Frame
baseline, 7 weeks, 6 months, 9 months, 12 months
Title
General quality of life questionnaire (mobility, self-care, daily activities, pain/discomfort, anxiety/depression)
Description
Is there a difference in the Quality-of-life between the 2 therapies during follow-up using ED-5D 5L questionnaire
Time Frame
baseline, 7 weeks, 6 months, 9 months, 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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) Does not tolerate catheterization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dick Janssen, MD, PhD
Phone
+31 6 41856516
Email
dick.janssen@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Cléo Baars, MD
Phone
+31 6 15400527
Email
cleo.baars@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dick Janssen, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dick Janssen, MD, PhD
Phone
+31641856516
Email
dick.janssen@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Cléo Baars, MD
Phone
+31 6 15400527
Email
cleo.baars@radboudumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only anonymous patient data will be shared

Learn more about this trial

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

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