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

Phase 4

Completed

• Conditions: Urinary Tract Infections
• Interventions: Drug: Arctuvan; Drug: Fosfomycin; Drug: Placebo to Fosfomycin; Drug: Placebo to Arctuvan

• Registration Number: NCT03151603
• Lead Sponsor: University Medical Center Goettingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-03
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Primary Completion: 2019-05-19
• Study Completion: 2019-06-20
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 398

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uva Ursi	Placebo to Fosfomycin	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
Uva Ursi	Arctuvan	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
fosfomycin	Placebo to Arctuvan	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.
fosfomycin	Fosfomycin	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.

Primary Outcome Measures

Name	Time	Method
antibiotic courses	day 0-28	number of antibiotic courses from day 0 to day 28
symptom burden	day 0-7	symptom burden (AUC) from day 0 to day 7

Secondary Outcome Measures

Name	Time	Method
activity impairment by UTI symptoms, measured as AUC	day 0-7	activity impairment by UTI symptoms (days 0-7), measured as AUC. Impairment by each UTI symptom is scored daily on a five point scale from 0 "none" to 4 "very strong".
painkillers	day 0-7	use of painkillers (Defined Daily Dose (DDD) day 0-7)
antibiotic use	day 0-28	antibiotic use (defined daily dose (DDD) day 0-28)
UTI related sick leave	day 0-28	number of days of UTI related sick leave day 0-28
AE and SAE	day 0-28	number of AE and SAE by system organ class day 0-28
patients taking painkillers	day 28	number of patients taking painkillers
UTI related visits	day 0-28	number of UTI related visits day 0-28
symptom sum score by patients' questionnaire	day 0-7	mean daily symptom sum scores from day 0 to day 7; Each of the symptoms dysuria, urgency, frequency and lower abdominal pain is scored daily on a five point scale from 0 "none" to 4 "very strong" in a patients' questionnaire.
symptom burden negative urine culture	day 0-7	symptom burden (AUC) day 0-7 of patients with negative urine culture
symptom burden for lower abdominal pain	day 0-7	symptom burden (AUC) for lower abdominal pain scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7
early relapses	day 0-14	number of early relapses until day 14
symptom resolution	day 4 and 7	number of patients with symptom resolution on day 4/7
patients with poor outcome: prolonged symptoms	day 0-28	number of patients with prolonged symptoms (\> 7 days), day 0-28. Patients will be followed up until symptom resolution, defined as max. 1 score point on each symptom scale.
pyelonephritis	day 0-28	number of pyelonephritis day 0-28, according to GP´s diagnosis
patients with at least 1 AE/ 2 AE	day 28	proportion of patients with at least 1 AE/ 2 AE
symptom burden for urgency	day 0-7	symptom burden (AUC) for urgency scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7
symptom burden for frequency	day 0-7	symptom burden (AUC) for frequency scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7
recurrent UTI	day 15-28	number of recurrent UTI day 15-28
symptom burden for dysuria	day 0-7	symptom burden (AUC) for dysuria scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7
symptom burden positive urine culture	day 0-7	symptom burden (AUC) day 0-7 of patients with positive urine culture
patients with poor outcome: temperature	day 0-7	number of patients with temperature \>38°C, day 0-7, according to patients´ statement
patients with poor outcome: worsening symptoms	day 28	number of patients with worsening symptoms (impairment in symptom score)

Trial Locations

Locations (47)

Hausarztpraxis Dr. Raby; 🇩🇪 Achim, Germany

General Practice Aden; 🇩🇪 Braunschweig, Germany

General Practice Scheffer; 🇩🇪 Braunschweig, Germany

General Practice Coutelle; 🇩🇪 Bremen, Germany

General Practice Schelp; 🇩🇪 Bremen, Germany

General Practice Dickow; 🇩🇪 Burgwedel, Germany

General Practice Kiwit-Putzer; 🇩🇪 Burgwedel, Germany

Praxis Zietz; 🇩🇪 Celle, Germany

General Practice Kutzsche; 🇩🇪 Emmerthal, Germany

Praxis Dr. Bahr; 🇩🇪 Gieboldehausen, Germany

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