ATAFUTI - A Trial Investigating Alternative Treatments of Adult Female Urinary Tract Infection.

Phase 1

• Conditions: Acute urinary tract infections.; MedDRA version: 19.0 Level: LLT Classification code 10000698 Term: Acute cystitis System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-003327-11-GB
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-17
• Study Completion: 2017-01-21
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 382

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
•Diabetes
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: At day 2 -4.;Primary end point(s): Symptom severity at day 2-4 recorded in a validated self report diary.;Main Objective: To evaluate whether Uva ursi compared to placebo or the advice to take ibuprofen compared to no advice provide relief from urinary symptoms in adult women with suspected UTI.;<br> Secondary Objective: To evaluate whether Uva ursi compared to placebo or the advice to take ibuprofen compared to no advice result in reduced antibiotic use in adult women with suspected UTI.<br><br> To determine the patient/practitioner barriers to implementation of a delayed antibiotic prescription approach and the use of herbal medication.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Use of antibiotics.<br> Duration of moderately bad symptoms.<br> Reconsultation in one and three months with UTI.<br>