Clinical trial NCT03151603: Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
Official title: Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: Uva Ursi
fosfomycin
uncomplicated urinary tract infection of women
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 398
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: antibiotic courses
timeFrame: day 0-28
measure: symptom burden
timeFrame: day 0-7
Secondary outcomes:
measure: early relapses
timeFrame: day 0-14
measure: recurrent UTI
timeFrame: day 15-28
measure: symptom resolution
timeFrame: day 4 and 7
measure: symptom sum score by patients' questionnaire
timeFrame: day 0-7
measure: symptom burden for dysuria
timeFrame: day 0-7
measure: symptom burden positive urine culture
timeFrame: day 0-7
measure: symptom burden negative urine culture
timeFrame: day 0-7
measure: activity impairment by UTI symptoms, measured as AUC
timeFrame: day 0-7
measure: painkillers
timeFrame: day 0-7
measure: patients taking painkillers
timeFrame: day 28
measure: antibiotic use
timeFrame: day 0-28
measure: UTI related visits
timeFrame: day 0-28
measure: UTI related sick leave
timeFrame: day 0-28
measure: patients with poor outcome: temperature
timeFrame: day 0-7
measure: patients with poor outcome: worsening symptoms
timeFrame: day 28
measure: patients with poor outcome: prolonged symptoms
timeFrame: day 0-28
measure: pyelonephritis
timeFrame: day 0-28
measure: AE and SAE
timeFrame: day 0-28
measure: patients with at least 1 AE/ 2 AE
timeFrame: day 28
measure: symptom burden for urgency
timeFrame: day 0-7
measure: symptom burden for frequency
timeFrame: day 0-7
measure: symptom burden for lower abdominal pain
timeFrame: day 0-7
Other outcomes:
Locations:
city: Achim
country: Germany
facility: Hausarztpraxis Dr. Raby
city: Braunschweig
country: Germany
facility: General Practice Aden
city: Braunschweig
country: Germany
facility: General Practice Scheffer
city: Bremen
country: Germany
facility: General Practice Coutelle
city: Bremen
country: Germany
facility: General Practice Schelp
city: Burgwedel
country: Germany
facility: General Practice Dickow
city: Burgwedel
country: Germany
facility: General Practice Kiwit-Putzer
city: Celle
country: Germany
facility: Praxis Zietz
city: Emmerthal
country: Germany
facility: General Practice Kutzsche
city: Gieboldehausen
country: Germany
facility: Praxis Dr. Bahr
city: Gillersheim
country: Germany
facility: General Practice Müller
city: Göttingen
country: Germany
facility: Institute of General Medicine, University Medical Center Goettingen
city: Göttingen
country: Germany
facility: Praxisgemeinschaft Jacob / Kling
city: Göttingen
country: Germany
facility: General Practice Keske
city: Göttingen
country: Germany
facility: General Practice Koch
city: Göttingen
country: Germany
facility: General Practice Kolb
city: Göttingen
country: Germany
facility: General Practice Lang
city: Göttingen
country: Germany
facility: General Practice Lückerath
city: Hannover
country: Germany
facility: Praxis Dr. Egner
city: Hannover
country: Germany
facility: Institute of General Medicine, MHH Hannover
city: Hannover
country: Germany
facility: General Practice Barth
city: Hardegsen
country: Germany
facility: General Practice Löber
city: Heilbad Heiligenstadt
country: Germany
facility: Gemeinschaftspraxis Dres Schlesier / Eckhardt
city: Heilbad Heiligenstadt
country: Germany
facility: Gemeinschaftspraxis Hartleb / Stöcking
city: Heilbad Heiligenstadt
country: Germany
facility: Praxis Dr. Koch
city: Herzberg
country: Germany
facility: Praxisgemeinschaft Seitz / Eckert
city: Hildesheim
country: Germany
facility: General Practice Wilde
city: Höxter
country: Germany
facility: Praxisgemeinschaft Stoltz / Raddatz
city: Höxter
country: Germany
facility: General Practice Beverungen
city: Isernhagen
country: Germany
facility: Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch
city: Katlenburg-Lindau
country: Germany
facility: General Practice Franz
city: Langenhagen
country: Germany
facility: Praxis Dr. Ohlendorf
city: Langwedel
country: Germany
facility: General Practice Ertel
city: Lemforde
country: Germany
facility: General Practice Wehrbein
city: Neustadt
country: Germany
facility: General Practice Lindenblatt
city: Nörten-Hardenberg
country: Germany
facility: Hausarztzentrum Nörten
city: Rehburg-Loccum
country: Germany
facility: General Practice Preiskorn
city: Rosdorf
country: Germany
facility: General Practice Meier-Ahrens
city: Salzgitter
country: Germany
facility: General Practice Woitschek
city: Sattenhausen
country: Germany
facility: General Practice Beulshausen
city: Scheeßel
country: Germany
facility: General Practice Schulte
city: Schwanewede
country: Germany
facility: General Practice Böttcher
city: Springe
country: Germany
facility: General Practice Albrecht
city: Uslar
country: Germany
facility: General Practice Wolf
city: Verden
country: Germany
facility: General Practice Schmiemann
city: Waake
country: Germany
facility: General Practice Annweiler
city: Wunstorf
country: Germany
facility: General Practice Stegemann
Study officials:
affiliation: University Medical Center Göttingen
name: Eva Hummers-Pradier, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Afshar 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.