Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
- Conditions
- Urinary Tract Infections
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 398
- Women (18-75 years) with suspected UTI
- at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)
- Written informed consent
- 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)
General Practice Schelp
🇩🇪Bremen, Germany
General Practice Aden
🇩🇪Braunschweig, Germany
General Practice Stegemann
🇩🇪Wunstorf, Germany
General Practice Annweiler
🇩🇪Waake, Germany
General Practice Scheffer
🇩🇪Braunschweig, Germany
Hausarztpraxis Dr. Raby
🇩🇪Achim, Germany
General Practice Coutelle
🇩🇪Bremen, Germany
General Practice Dickow
🇩🇪Burgwedel, Germany
General Practice Kiwit-Putzer
🇩🇪Burgwedel, Germany
General Practice Kutzsche
🇩🇪Emmerthal, Germany
Praxis Zietz
🇩🇪Celle, Germany
General Practice Müller
🇩🇪Gillersheim, Germany
Praxis Dr. Bahr
🇩🇪Gieboldehausen, Germany
Institute of General Medicine, University Medical Center Goettingen
🇩🇪Göttingen, Germany
Praxisgemeinschaft Jacob / Kling
🇩🇪Göttingen, Germany
General Practice Keske
🇩🇪Göttingen, Germany
General Practice Koch
🇩🇪Göttingen, Germany
General Practice Kolb
🇩🇪Göttingen, Germany
General Practice Lückerath
🇩🇪Göttingen, Germany
General Practice Lang
🇩🇪Göttingen, Germany
Praxis Dr. Egner
🇩🇪Hannover, Germany
General Practice Löber
🇩🇪Hardegsen, Germany
Institute of General Medicine, MHH Hannover
🇩🇪Hannover, Germany
General Practice Barth
🇩🇪Hannover, Germany
Gemeinschaftspraxis Dres Schlesier / Eckhardt
🇩🇪Heilbad Heiligenstadt, Germany
Gemeinschaftspraxis Hartleb / Stöcking
🇩🇪Heilbad Heiligenstadt, Germany
Praxisgemeinschaft Seitz / Eckert
🇩🇪Herzberg, Germany
Praxisgemeinschaft Stoltz / Raddatz
🇩🇪Höxter, Germany
General Practice Wilde
🇩🇪Hildesheim, Germany
Praxis Dr. Koch
🇩🇪Heilbad Heiligenstadt, Germany
Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch
🇩🇪Isernhagen, Germany
General Practice Beverungen
🇩🇪Höxter, Germany
General Practice Franz
🇩🇪Katlenburg-Lindau, Germany
Praxis Dr. Ohlendorf
🇩🇪Langenhagen, Germany
General Practice Ertel
🇩🇪Langwedel, Germany
General Practice Wehrbein
🇩🇪Lemforde, Germany
General Practice Preiskorn
🇩🇪Rehburg-Loccum, Germany
General Practice Lindenblatt
🇩🇪Neustadt, Germany
Hausarztzentrum Nörten
🇩🇪Nörten-Hardenberg, Germany
General Practice Woitschek
🇩🇪Salzgitter, Germany
General Practice Beulshausen
🇩🇪Sattenhausen, Germany
General Practice Meier-Ahrens
🇩🇪Rosdorf, Germany
General Practice Schulte
🇩🇪Scheeßel, Germany
General Practice Böttcher
🇩🇪Schwanewede, Germany
General Practice Albrecht
🇩🇪Springe, Germany
General Practice Wolf
🇩🇪Uslar, Germany
General Practice Schmiemann
🇩🇪Verden, Germany