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

NCT ID: NCT03151603

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2019-06-20

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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Uva Ursi

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

Group Type: EXPERIMENTAL

Arctuvan

Intervention Type: DRUG

application of a herbal drug

Placebo to Fosfomycin

Intervention Type: DRUG

application of Placebo to 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.

Group Type: ACTIVE_COMPARATOR

Fosfomycin

Intervention Type: DRUG

application of an antibiotic drug

Placebo to Arctuvan

Intervention Type: DRUG

application of Placebo to Arctuvan

Interventions

Arctuvan

application of a herbal drug

Intervention Type: DRUG

Fosfomycin

application of an antibiotic drug

Intervention Type: DRUG

Placebo to Arctuvan

application of Placebo to Arctuvan

Intervention Type: DRUG

Placebo to Fosfomycin

application of Placebo to Fosfomycin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Goettingen

OTHER

Sponsor Role: lead

Responsible Party

Karsten Gavenis

Quality Assurance Staff Unit Clinical Trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Hummers-Pradier, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Göttingen

Locations

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

General Practice Müller

Gillersheim, , 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 Lang

Göttingen, , Germany

General Practice Lückerath

Göttingen, , Germany

Praxis Dr. Egner

Hanover, , Germany

Institute of General Medicine, MHH Hannover

Hanover, , Germany

General Practice Barth

Hanover, , Germany

General Practice Löber

Hardegsen, , Germany

Gemeinschaftspraxis Dres Schlesier / Eckhardt

Heilbad Heiligenstadt, , Germany

Gemeinschaftspraxis Hartleb / Stöcking

Heilbad Heiligenstadt, , Germany

Praxis Dr. Koch

Heilbad Heiligenstadt, , Germany

Praxisgemeinschaft Seitz / Eckert

Herzberg, , Germany

General Practice Wilde

Hildesheim, , Germany

Praxisgemeinschaft Stoltz / Raddatz

Höxter, , Germany

General Practice Beverungen

Höxter, , Germany

Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch

Isernhagen-Süd, , Germany

General Practice Franz

Katlenburg-Lindau, , Germany

Praxis Dr. Ohlendorf

Langenhagen, , Germany

General Practice Ertel

Langwedel, , Germany

General Practice Wehrbein

Lemförde, , Germany

General Practice Lindenblatt

Neustadt, , Germany

Hausarztzentrum Nörten

Nörten-Hardenberg, , 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, , Germany

General Practice Schmiemann

Verden an der Aller, , Germany

General Practice Annweiler

Waake, , Germany

General Practice Stegemann

Wunstorf, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34111592 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29970072 (View on PubMed)

Other Identifiers

01579

Identifier Type: -

Identifier Source: org_study_id