Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
REGATTA
1 other identifier
interventional
398
1 country
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2017
Typical duration for phase_4
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2017
CompletedFirst Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2019
CompletedNovember 27, 2019
November 1, 2019
2 years
May 10, 2017
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
antibiotic courses
number of antibiotic courses from day 0 to day 28
day 0-28
symptom burden
symptom burden (AUC) from day 0 to day 7
day 0-7
Secondary Outcomes (22)
early relapses
day 0-14
recurrent UTI
day 15-28
symptom resolution
day 4 and 7
symptom sum score by patients' questionnaire
day 0-7
symptom burden for dysuria
day 0-7
- +17 more secondary outcomes
Study Arms (2)
Uva Ursi
EXPERIMENTALplacebo 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
ACTIVE COMPARATORfosfomycin (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.
Interventions
Eligibility Criteria
You may qualify if:
- Women (18-75 years) with suspected UTI
- at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Hausarztpraxis Dr. Raby
Achim, 28832, 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, 29221, Germany
General Practice Kutzsche
Emmerthal, Germany
Praxis Dr. Bahr
Gieboldehausen, 37434, Germany
General Practice Müller
Gillersheim, Germany
Institute of General Medicine, University Medical Center Goettingen
Göttingen, 37073, Germany
Praxisgemeinschaft Jacob / Kling
Göttingen, 37083, Germany
General Practice Keske
Göttingen, Germany
General Practice Koch
Göttingen, Germany
General Practice Kolb
Göttingen, Germany
General Practice Lang
Göttingen, Germany
General Practice Lückerath
Göttingen, Germany
Praxis Dr. Egner
Hanover, 30161, Germany
Institute of General Medicine, MHH Hannover
Hanover, 30625, Germany
General Practice Barth
Hanover, Germany
General Practice Löber
Hardegsen, Germany
Gemeinschaftspraxis Dres Schlesier / Eckhardt
Heilbad Heiligenstadt, 37308, Germany
Gemeinschaftspraxis Hartleb / Stöcking
Heilbad Heiligenstadt, 37308, Germany
Praxis Dr. Koch
Heilbad Heiligenstadt, 37308, Germany
Praxisgemeinschaft Seitz / Eckert
Herzberg, 37412, Germany
General Practice Wilde
Hildesheim, Germany
Praxisgemeinschaft Stoltz / Raddatz
Höxter, 37671, Germany
General Practice Beverungen
Höxter, Germany
Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch
Isernhagen-Süd, 30916, Germany
General Practice Franz
Katlenburg-Lindau, Germany
Praxis Dr. Ohlendorf
Langenhagen, 30851, Germany
General Practice Ertel
Langwedel, Germany
General Practice Wehrbein
Lemförde, Germany
General Practice Lindenblatt
Neustadt, Germany
Hausarztzentrum Nörten
Nörten-Hardenberg, 37176, Germany
General Practice Preiskorn
Rehburg-Loccum, Germany
General Practice Meier-Ahrens
Rosdorf, Germany
General Practice Woitschek
Salzgitter, Germany
General Practice Beulshausen
Sattenhausen, Germany
General Practice Schulte
Scheeßel, Germany
General Practice Böttcher
Schwanewede, Germany
General Practice Albrecht
Springe, Germany
General Practice Wolf
Uslar, 37170, Germany
General Practice Schmiemann
Verden an der Aller, Germany
General Practice Annweiler
Waake, Germany
General Practice Stegemann
Wunstorf, Germany
Related Publications (2)
Gagyor I, Hummers E, Schmiemann G, Friede T, Pfeiffer S, Afshar K, Bleidorn J. Herbal treatment with uva ursi extract versus fosfomycin in women with uncomplicated urinary tract infection in primary care: a randomized controlled trial. Clin Microbiol Infect. 2021 Oct;27(10):1441-1447. doi: 10.1016/j.cmi.2021.05.032. Epub 2021 Jun 7.
PMID: 34111592DERIVEDAfshar K, Fleischmann N, Schmiemann G, Bleidorn J, Hummers-Pradier E, Friede T, Wegscheider K, Moore M, Gagyor I. Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) - a double-blind, randomized, controlled comparative effectiveness trial. BMC Complement Altern Med. 2018 Jul 3;18(1):203. doi: 10.1186/s12906-018-2266-x.
PMID: 29970072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Hummers-Pradier, Prof. Dr.
University Medical Center Göttingen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Quality Assurance Staff Unit Clinical Trials
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 12, 2017
Study Start
May 3, 2017
Primary Completion
May 19, 2019
Study Completion
June 20, 2019
Last Updated
November 27, 2019
Record last verified: 2019-11