Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial (REGATTA)

University Medical Center Goettingen

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Arctuvan; Drug: Placebo to Arctuvan; Drug: Fosfomycin; Drug: Placebo to Fosfomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03151603

01579

Details and patient eligibility

About

It is well known that "over-treatment" of straightforward infections should be avoided as far as possible. Evidence-based data on non antibiotic treatment options for common conditions are therefore needed urgently. This randomised-controlled double blind trial examines whether initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist, reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients presenting with typical UTI symptoms will be included by their GPs and receive randomised either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial antibiotic treatment. Patients record symptom severity and drug intake in a diary and complete a final questionnaire after 28 days.

Enrollment: 398 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women (18-75 years) with suspected UTI
• at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)
• Written informed consent

Exclusion criteria

• signs of complicated UTI (e. g. temperature > 38°C, loin tenderness)
• conditions that may lead to complicated infections (i.e. renal diseases, patients with urinary catheter)
• pregnancy/ breastfeeding
• current self-medication with UU preparations e.g. z.B. Cystinol®, Uvalysat®, Arctuvan®
• antibiotic use in the last 7 days
• previous UTI in the past 2 weeks
• history of pyelonephritis
• contraindications for trial drugs
• serious diseases
• inability to understand trial Information
• current participation in another clinical trial or participation in another clinical trial within the last 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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398 participants in 2 patient groups

Uva Ursi

Experimental group

Description:

placebo to fosfomycin: 3 g granules orally 1x1 (day 0) and Uva Ursi: 105 mg (Arctuvan®) 3x2 tablets orally from day 0 for 5 days

Treatment:

Drug: Arctuvan

Drug: Placebo to Fosfomycin

fosfomycin

Active Comparator group

Description:

fosfomycin (Monuril®): 3 g granules orally 1x1 (day 0), and placebo to Uva Ursi: 3x2 tablets orally from day 0 for 5 days If the patient returns with persistent/recurrent symptoms, antibiotic therapy according to the sensitivity test.

Treatment:

Drug: Fosfomycin

Drug: Placebo to Arctuvan