Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT05652374

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

Led by Radboud University Medical Center · Updated on 2024-11-18

100

Participants Needed

3

Research Sites

258 weeks

Total Duration

On this page

Sponsors

R

Radboud University Medical Center

Lead Sponsor

I

IBSA Institut Biochimique SA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult female patients (>18 years) who had at least 3 symptomatic urinary tract infections in the previous year with no adequate curable therapeutic options
  • At least one urinary tract infection must be confirmed with a positive culture and antibiogram
  • Further urinary tract infections must be confirmed with urine sediment positive for nitrite or a positive culture
Not Eligible

You will not qualify if you...

  • Male
  • Under 18 years old
  • Pregnant
  • Already receiving GAG therapy
  • Already on prophylactic antibiotics
  • Started or stopped cranberry/d-mannose therapy or vaginal estrogen cream in the last two months
  • Had gentamicin or other antibiotic instillations in the previous two months
  • Allergic to more than three regularly used antibiotics in Dutch guidelines (including nitrofurantoin, trimethoprim, fosfomycin)
  • Presence of urinary fistula
  • Urinary stones
  • Urogenital cancer
  • Bladder Pain Syndrome or Interstitial Cystitis
  • Chronic pelvic pain
  • Had a sexually transmitted disease untreated or treated in the previous two months
  • Urinary diversion
  • Indwelling catheter
  • Suprapubic catheter
  • Performing self-catheterization more than once per day
  • Post-void residual urine volume greater than 200ml
  • Unable or legally incapable of giving informed consent
  • Recurrent urosepsis
  • Multiresistant bacteria found in previous urine cultures
  • Contraindications or interactions for nitrofurantoin (severe kidney dysfunction with GFR < 30, lung or liver problems, neuropathy from previous nitrofurantoin use, acute porphyria, known G6PD deficiency, use of magnesium trisilicate)
  • Contraindications or interactions for trimethoprim (severe kidney or liver dysfunction, abnormal blood count, use of vitamin K antagonists, folic acid antagonists, or ACE inhibitors)
  • Severe lung or respiratory dysfunction (reduced lung capacity, lung cancer, fibrosis, COPD)
  • Does not tolerate catheterization

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Radboudumc

Nijmegen, Gelderland, Netherlands, 6525 GA

Actively Recruiting

2

Rijnstate ziekenhuis

Arnhem, Netherlands

Actively Recruiting

3

Canisius wilhelmina ziekenhuis

Nijmegen, Netherlands

Actively Recruiting

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Research Team

D

Dick Janssen, MD, PhD

CONTACT

C

Cléo Baars, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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