Recurrent Urinary Tract InfectionPhase 4GT RACINGNCT05652374
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
A Phase 4 study testing Ialuril 50ml Prefill and Nitrofurantoin in people with Recurrent Urinary Tract Infection, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Ialuril 50ml Prefill and Nitrofurantoin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesNetherlands
- Study dates
- 20 Oct 2022to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Rijnstate ziekenhuis
Arnhem
Michael van Balken, +31880058888, mvanbalken@rijnstate.nl
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Dick Janssen, MD, PhD, +31641856516, dick.janssen@radboudumc.nl
Cléo Baars, MD, +31 6 15400527, cleo.baars@radboudumc.nl
- Recruiting
Canisius wilhelmina ziekenhuis
Nijmegen
Rianne Hendriks, +31243658961, r.hendriks@cwz.nl
About this study
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).
Read the 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 cross-over RCT, 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: 50ml of sterile Ialuril (HA 1.6% CS 2%) weekly for 6 weeks, followed by monthly maintenance therapy for 6 months.
Control : oral nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.
All patients recieve both treatments (ialuril and nitrofurantoin) consecutively, for 6 months each. The order of the therapies is determined by randomisation. Between therapies there is a 4 weeks 'wash-out' period. A total of 100 patients will be included.
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.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Ialuril 50ml Prefill, Nitrofurantoin
- Keywords
- GAG therapy, Prophylactic antibiotics
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ialuril 50ml PrefillDevice
Also called HA-CS
50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 6 months
NitrofurantoinDrug
nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Ialuril therapy for 6 months followed by nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months. In between therapies there is a 4 week wash-out period. Receives: Device: Ialuril 50ml Prefill; Drug: Nitrofurantoin |
| Group B | Other | Nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months followed by Ialuril therapy for 6 months. In between therapies there is a 4 week wash-out period. Receives: Device: Ialuril 50ml Prefill; Drug: Nitrofurantoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of urinary tract infections
Number of urinary tract infections per patient-year
Measured: 13 months
Secondary outcomes (7)
Time to first urinary tract infection
Time to first urinary tract infection
Measured: 13 months
Global Assessment of Improvement
Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best)
Measured: 7 weeks, 3 months, 6 months after start of each therapy
Antibiotics resistance
Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups
Measured: Baseline, 6 months after start of each therapy
Cost-effectiveness: medical consumption questionnaire
Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire'
Measured: Baseline, 6 months after start of each therapy
Cost-effectiveness: productivity cost questionnaire
Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'productivity cost questionnaire'
Measured: Baseline, 6 months after start of each therapy
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)
Measured: baseline, 7 weeks, 3 months, 6 months after start of each 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
Measured: baseline, 7 weeks, 3 months, 6 months after start of each therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start20 Oct 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cross-over randomized controlled trial. Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- IBSA Institut Biochimique SA, Goodlife Pharma B.V.
- Responsible party
- Sponsor
- Investigators
- Dick Janssen, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652374
- Sponsor's protocol ID
- 111802
- Other IDs
- NL76892.091.21
- Acronym
- GT RACING
- Status last verified
- Jul 2024
- First submitted
- 23 Nov 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only anonymous patient data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
- ClinicalTrials.gov ID
- NCT05652374
- Acronym / sponsor ID
- GT RACING / 111802
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- GAG therapy, Prophylactic antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- IBSA Institut Biochimique SA, Goodlife Pharma B.V.
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 cross-over RCT, 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: 50ml of sterile Ialuril (HA 1.6% CS 2%) weekly for 6 weeks, followed by monthly maintenance therapy for 6 months.
Control : oral nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.
All patients recieve both treatments (ialuril and nitrofurantoin) consecutively, for 6 months each. The order of the therapies is determined by randomisation. Between therapies there is a 4 weeks 'wash-out' period. A total of 100 patients will be included.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-over randomized controlled trial. Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: Ialuril 50ml Prefill, Drug: NitrofurantoinIaluril therapy for 6 months followed by nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months. In between therapies there is a 4 week wash-out period. |
| Group B | Other | Device: Ialuril 50ml Prefill, Drug: NitrofurantoinNitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months followed by Ialuril therapy for 6 months. In between therapies there is a 4 week wash-out period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (26 listed)
- Male
- < 18 years
- Pregnant
- Already on GAG therapy
- Already on prophylactic antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ialuril 50ml PrefillAlso: HA-CS50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 6 months | Device | Group A, Group B |
| Nitrofurantoinnitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily) | Drug | Group A, Group B |
Primary outcome
Number of urinary tract infections
Time frame: 13 months
Number of urinary tract infections per patient-year
7 secondary outcomes
Time to first urinary tract infection
Time frame: 13 months
Global Assessment of Improvement
Time frame: 7 weeks, 3 months, 6 months after start of each therapy
Antibiotics resistance
Time frame: Baseline, 6 months after start of each therapy
Cost-effectiveness: medical consumption questionnaire
Time frame: Baseline, 6 months after start of each therapy
Cost-effectiveness: productivity cost questionnaire
Time frame: Baseline, 6 months after start of each therapy
Therapy specific patient reported outcomes (symptoms & bother)
Time frame: baseline, 7 weeks, 3 months, 6 months after start of each therapy
General quality of life questionnaire (mobility, self-care, daily activities, pain/discomfort, anxiety/depression)
Time frame: baseline, 7 weeks, 3 months, 6 months after start of each therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No. only anonymous patient data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dick Janssen, MD, PhD principal investigator
Radboud University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ialuril 50ml Prefill and Nitrofurantoin in people with Recurrent Urinary Tract Infection, run by Radboud University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dick Janssen, MD, PhD (+31 6 41856516, dick.janssen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of urinary tract infections (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.