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

Urinary Tract Infections Clinical Trial

— REGATTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151603
• Other study ID #: 01579
• Status: Completed
• Phase: Phase 4
• Start date: May 3, 2017
• Est. completion date: June 20, 2019

Study information

• Verified date: November 2019
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: June 20, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Arctuvan
application of a herbal drug
• Fosfomycin
application of an antibiotic drug
• Placebo to Arctuvan
application of Placebo to Arctuvan
• Placebo to Fosfomycin
application of Placebo to Fosfomycin

Locations

Country	Name	City	State
Germany	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	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	Institute of General Medicine, University Medical Center Goettingen	Göttingen
Germany	Praxisgemeinschaft Jacob / Kling	Göttingen
Germany	General Practice Barth	Hannover
Germany	Institute of General Medicine, MHH Hannover	Hannover
Germany	Praxis Dr. Egner	Hannover
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	General Practice Beverungen	Höxter
Germany	Praxisgemeinschaft Stoltz / Raddatz	Höxter
Germany	Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch	Isernhagen
Germany	General Practice Franz	Katlenburg-Lindau
Germany	Praxis Dr. Ohlendorf	Langenhagen
Germany	General Practice Ertel	Langwedel
Germany	General Practice Wehrbein	Lemforde
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
Germany	General Practice Annweiler	Waake
Germany	General Practice Stegemann	Wunstorf

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antibiotic courses	number of antibiotic courses from day 0 to day 28	day 0-28
Primary	symptom burden	symptom burden (AUC) from day 0 to day 7	day 0-7
Secondary	early relapses	number of early relapses until day 14	day 0-14
Secondary	recurrent UTI	number of recurrent UTI day 15-28	day 15-28
Secondary	symptom resolution	number of patients with symptom resolution on day 4/7	day 4 and 7
Secondary	symptom sum score by patients' questionnaire	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.	day 0-7
Secondary	symptom burden for dysuria	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	day 0-7
Secondary	symptom burden positive urine culture	symptom burden (AUC) day 0-7 of patients with positive urine culture	day 0-7
Secondary	symptom burden negative urine culture	symptom burden (AUC) day 0-7 of patients with negative urine culture	day 0-7
Secondary	activity impairment by UTI symptoms, measured as AUC	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".	day 0-7
Secondary	painkillers	use of painkillers (Defined Daily Dose (DDD) day 0-7)	day 0-7
Secondary	patients taking painkillers	number of patients taking painkillers	day 28
Secondary	antibiotic use	antibiotic use (defined daily dose (DDD) day 0-28)	day 0-28
Secondary	UTI related visits	number of UTI related visits day 0-28	day 0-28
Secondary	UTI related sick leave	number of days of UTI related sick leave day 0-28	day 0-28
Secondary	patients with poor outcome: temperature	number of patients with temperature >38°C, day 0-7, according to patients´ statement	day 0-7
Secondary	patients with poor outcome: worsening symptoms	number of patients with worsening symptoms (impairment in symptom score)	day 28
Secondary	patients with poor outcome: prolonged symptoms	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.	day 0-28
Secondary	pyelonephritis	number of pyelonephritis day 0-28, according to GP´s diagnosis	day 0-28
Secondary	AE and SAE	number of AE and SAE by system organ class day 0-28	day 0-28
Secondary	patients with at least 1 AE/ 2 AE	proportion of patients with at least 1 AE/ 2 AE	day 28
Secondary	symptom burden for urgency	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	day 0-7
Secondary	symptom burden for frequency	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	day 0-7
Secondary	symptom burden for lower abdominal pain	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	day 0-7