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

NCT05652374 | Recruiting Phase 4 DMC

• 2 other identifiers: 111802NL76892.091.21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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).

Conditions

Recurrent Urinary Tract Infection

Keywords

GAG therapy; Prophylactic antibiotics

Outcome Measures

Primary Outcomes (1)

• Number of urinary tract infections

  Number of urinary tract infections per patient-year

  13 months

Secondary Outcomes (7)

• Time to first urinary tract infection

  13 months

• Global Assessment of Improvement

  7 weeks, 3 months, 6 months after start of each therapy

• Antibiotics resistance

  Baseline, 6 months after start of each therapy

• Cost-effectiveness: medical consumption questionnaire

  Baseline, 6 months after start of each therapy

• Cost-effectiveness: productivity cost questionnaire

  Baseline, 6 months after start of each therapy

Study Arms (2)

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.

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.

Device: Ialuril 50ml Prefill; Drug: Nitrofurantoin

Interventions

Ialuril 50ml Prefill DEVICE

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

Also known as: HA-CS

Group A; Group B

Nitrofurantoin DRUG

nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (3)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Rijnstate ziekenhuis

Arnhem, Netherlands

RECRUITING

Canisius wilhelmina ziekenhuis

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dick Janssen, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dick Janssen, MD, PhD

CONTACT

+31 6 41856516; dick.janssen@radboudumc.nl

Cléo Baars, MD

CONTACT

+31 6 15400527; cleo.baars@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over randomized controlled trial. Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 15, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)