EUCTR2013-003327-11-GBActive, not recruitingPhase 1
Alternative Treatments of Adult female Urinary Tract Infection: a double blind, placebo controlled,factorial randomised trial of Uva ursi and open pragmatic trial of ibuprofen. - ATAFUTI
niversity of Southampton0 sites382 target enrollmentStarted: December 17, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 382
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Adult women (18-70) presenting to primary care with suspected lower urinary tract infection i.e. with at least one of dysuria, urgency or frequency.
- •Patient able to provide informed written consent.
- •Women willing to accept a delayed prescription for antibiotics.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 376
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
- •Known or suspected pregnancy or breast feeding
- •In women of child bearing age a urine pregnancy test will usually be performed unless not indicated (for instance prior hysterectomy)
- •Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
- •Has any of the following (A – F) known contra-indications or cautions to Ibuprofen and any as listed in the current SmPC:
- •A. Asthmatics sensitive to NSAIDS/ Ibuprofen or Aspirin
- •B. Severe heart failure and uncontrolled hypertension
- •C. Active gastro-intestinal ulceration or bleeding
- •D. Crohn’s disease or ulcerative colitis
- •E. Documented poor renal function
- •F. Chronic Kidney disease (Grade 3 - 5)
- •Currently or within 7 days taken antibiotics
- •Using a NSAID or Uva Ursi preparation and unwilling to discontinue for the study period
- •Suspected upper urinary tract infection (back pain, high fever>38C, systemic illness)
- •Women whom immediate antibiotics are otherwise indicated - frequent recurrent infection: >3 UTI episodes in past 12 months
- •Defect of the blood clotting system
- •Bladder surgery including cystoscopy in the last four weeks.
- •Currently taking Warfarin
- •Recruited to another interventional randomised control trial in previous 4 weeks.
Investigators
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