Back to resultsReducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial (REGATTA)
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Arctuvan
Fosfomycin
Placebo to Arctuvan
Placebo to Fosfomycin
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections focused on measuring Uva Ursi, fosfomycin, uncomplicated urinary tract infection of women
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
Sites / Locations
- Hausarztpraxis Dr. Raby
- General Practice Aden
- General Practice Scheffer
- General Practice Coutelle
- General Practice Schelp
- General Practice Dickow
- General Practice Kiwit-Putzer
- Praxis Zietz
- General Practice Kutzsche
- Praxis Dr. Bahr
- General Practice Müller
- Institute of General Medicine, University Medical Center Goettingen
- Praxisgemeinschaft Jacob / Kling
- General Practice Keske
- General Practice Koch
- General Practice Kolb
- General Practice Lang
- General Practice Lückerath
- Praxis Dr. Egner
- Institute of General Medicine, MHH Hannover
- General Practice Barth
- General Practice Löber
- Gemeinschaftspraxis Dres Schlesier / Eckhardt
- Gemeinschaftspraxis Hartleb / Stöcking
- Praxis Dr. Koch
- Praxisgemeinschaft Seitz / Eckert
- General Practice Wilde
- Praxisgemeinschaft Stoltz / Raddatz
- General Practice Beverungen
- Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch
- General Practice Franz
- Praxis Dr. Ohlendorf
- General Practice Ertel
- General Practice Wehrbein
- General Practice Lindenblatt
- Hausarztzentrum Nörten
- General Practice Preiskorn
- General Practice Meier-Ahrens
- General Practice Woitschek
- General Practice Beulshausen
- General Practice Schulte
- General Practice Böttcher
- General Practice Albrecht
- General Practice Wolf
- General Practice Schmiemann
- General Practice Annweiler
- General Practice Stegemann
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Uva Ursi
fosfomycin
Arm Description
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 (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.
Outcomes
Primary Outcome Measures
antibiotic courses
number of antibiotic courses from day 0 to day 28
symptom burden
symptom burden (AUC) from day 0 to day 7
Secondary Outcome Measures
early relapses
number of early relapses until day 14
recurrent UTI
number of recurrent UTI day 15-28
symptom resolution
number of patients with symptom resolution on day 4/7
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.
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
symptom burden positive urine culture
symptom burden (AUC) day 0-7 of patients with positive urine culture
symptom burden negative urine culture
symptom burden (AUC) day 0-7 of patients with negative urine culture
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".
painkillers
use of painkillers (Defined Daily Dose (DDD) day 0-7)
patients taking painkillers
number of patients taking painkillers
antibiotic use
antibiotic use (defined daily dose (DDD) day 0-28)
UTI related visits
number of UTI related visits day 0-28
UTI related sick leave
number of days of UTI related sick leave day 0-28
patients with poor outcome: temperature
number of patients with temperature >38°C, day 0-7, according to patients´ statement
patients with poor outcome: worsening symptoms
number of patients with worsening symptoms (impairment in symptom score)
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.
pyelonephritis
number of pyelonephritis day 0-28, according to GP´s diagnosis
AE and SAE
number of AE and SAE by system organ class day 0-28
patients with at least 1 AE/ 2 AE
proportion of patients with at least 1 AE/ 2 AE
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
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
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
Full Information
NCT ID
NCT03151603
First Posted
May 10, 2017
Last Updated
November 26, 2019
Sponsor
University Medical Center Goettingen
1. Study Identification
Unique Protocol Identification Number
NCT03151603
Brief Title
Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
Acronym
REGATTA
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
May 19, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Goettingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Uva Ursi, fosfomycin, uncomplicated urinary tract infection of women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
398 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uva Ursi
Arm Type
Experimental
Arm Description
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
Arm Title
fosfomycin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Arctuvan
Intervention Description
application of a herbal drug
Intervention Type
Drug
Intervention Name(s)
Fosfomycin
Intervention Description
application of an antibiotic drug
Intervention Type
Drug
Intervention Name(s)
Placebo to Arctuvan
Intervention Description
application of Placebo to Arctuvan
Intervention Type
Drug
Intervention Name(s)
Placebo to Fosfomycin
Intervention Description
application of Placebo to Fosfomycin
Primary Outcome Measure Information:
Title
antibiotic courses
Description
number of antibiotic courses from day 0 to day 28
Time Frame
day 0-28
Title
symptom burden
Description
symptom burden (AUC) from day 0 to day 7
Time Frame
day 0-7
Secondary Outcome Measure Information:
Title
early relapses
Description
number of early relapses until day 14
Time Frame
day 0-14
Title
recurrent UTI
Description
number of recurrent UTI day 15-28
Time Frame
day 15-28
Title
symptom resolution
Description
number of patients with symptom resolution on day 4/7
Time Frame
day 4 and 7
Title
symptom sum score by patients' questionnaire
Description
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.
Time Frame
day 0-7
Title
symptom burden for dysuria
Description
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
Time Frame
day 0-7
Title
symptom burden positive urine culture
Description
symptom burden (AUC) day 0-7 of patients with positive urine culture
Time Frame
day 0-7
Title
symptom burden negative urine culture
Description
symptom burden (AUC) day 0-7 of patients with negative urine culture
Time Frame
day 0-7
Title
activity impairment by UTI symptoms, measured as AUC
Description
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".
Time Frame
day 0-7
Title
painkillers
Description
use of painkillers (Defined Daily Dose (DDD) day 0-7)
Time Frame
day 0-7
Title
patients taking painkillers
Description
number of patients taking painkillers
Time Frame
day 28
Title
antibiotic use
Description
antibiotic use (defined daily dose (DDD) day 0-28)
Time Frame
day 0-28
Title
UTI related visits
Description
number of UTI related visits day 0-28
Time Frame
day 0-28
Title
UTI related sick leave
Description
number of days of UTI related sick leave day 0-28
Time Frame
day 0-28
Title
patients with poor outcome: temperature
Description
number of patients with temperature >38°C, day 0-7, according to patients´ statement
Time Frame
day 0-7
Title
patients with poor outcome: worsening symptoms
Description
number of patients with worsening symptoms (impairment in symptom score)
Time Frame
day 28
Title
patients with poor outcome: prolonged symptoms
Description
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.
Time Frame
day 0-28
Title
pyelonephritis
Description
number of pyelonephritis day 0-28, according to GP´s diagnosis
Time Frame
day 0-28
Title
AE and SAE
Description
number of AE and SAE by system organ class day 0-28
Time Frame
day 0-28
Title
patients with at least 1 AE/ 2 AE
Description
proportion of patients with at least 1 AE/ 2 AE
Time Frame
day 28
Title
symptom burden for urgency
Description
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
Time Frame
day 0-7
Title
symptom burden for frequency
Description
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
Time Frame
day 0-7
Title
symptom burden for lower abdominal pain
Description
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
Time Frame
day 0-7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Hummers-Pradier, Prof. Dr.
Organizational Affiliation
University Medical Center Göttingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hausarztpraxis Dr. Raby
City
Achim
ZIP/Postal Code
28832
Country
Germany
Facility Name
General Practice Aden
City
Braunschweig
Country
Germany
Facility Name
General Practice Scheffer
City
Braunschweig
Country
Germany
Facility Name
General Practice Coutelle
City
Bremen
Country
Germany
Facility Name
General Practice Schelp
City
Bremen
Country
Germany
Facility Name
General Practice Dickow
City
Burgwedel
Country
Germany
Facility Name
General Practice Kiwit-Putzer
City
Burgwedel
Country
Germany
Facility Name
Praxis Zietz
City
Celle
ZIP/Postal Code
29221
Country
Germany
Facility Name
General Practice Kutzsche
City
Emmerthal
Country
Germany
Facility Name
Praxis Dr. Bahr
City
Gieboldehausen
ZIP/Postal Code
37434
Country
Germany
Facility Name
General Practice Müller
City
Gillersheim
Country
Germany
Facility Name
Institute of General Medicine, University Medical Center Goettingen
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
Praxisgemeinschaft Jacob / Kling
City
Göttingen
ZIP/Postal Code
37083
Country
Germany
Facility Name
General Practice Keske
City
Göttingen
Country
Germany
Facility Name
General Practice Koch
City
Göttingen
Country
Germany
Facility Name
General Practice Kolb
City
Göttingen
Country
Germany
Facility Name
General Practice Lang
City
Göttingen
Country
Germany
Facility Name
General Practice Lückerath
City
Göttingen
Country
Germany
Facility Name
Praxis Dr. Egner
City
Hannover
ZIP/Postal Code
30161
Country
Germany
Facility Name
Institute of General Medicine, MHH Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
General Practice Barth
City
Hannover
Country
Germany
Facility Name
General Practice Löber
City
Hardegsen
Country
Germany
Facility Name
Gemeinschaftspraxis Dres Schlesier / Eckhardt
City
Heilbad Heiligenstadt
ZIP/Postal Code
37308
Country
Germany
Facility Name
Gemeinschaftspraxis Hartleb / Stöcking
City
Heilbad Heiligenstadt
ZIP/Postal Code
37308
Country
Germany
Facility Name
Praxis Dr. Koch
City
Heilbad Heiligenstadt
ZIP/Postal Code
37308
Country
Germany
Facility Name
Praxisgemeinschaft Seitz / Eckert
City
Herzberg
ZIP/Postal Code
37412
Country
Germany
Facility Name
General Practice Wilde
City
Hildesheim
Country
Germany
Facility Name
Praxisgemeinschaft Stoltz / Raddatz
City
Höxter
ZIP/Postal Code
37671
Country
Germany
Facility Name
General Practice Beverungen
City
Höxter
Country
Germany
Facility Name
Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch
City
Isernhagen
ZIP/Postal Code
30916
Country
Germany
Facility Name
General Practice Franz
City
Katlenburg-Lindau
Country
Germany
Facility Name
Praxis Dr. Ohlendorf
City
Langenhagen
ZIP/Postal Code
30851
Country
Germany
Facility Name
General Practice Ertel
City
Langwedel
Country
Germany
Facility Name
General Practice Wehrbein
City
Lemforde
Country
Germany
Facility Name
General Practice Lindenblatt
City
Neustadt
Country
Germany
Facility Name
Hausarztzentrum Nörten
City
Nörten-Hardenberg
ZIP/Postal Code
37176
Country
Germany
Facility Name
General Practice Preiskorn
City
Rehburg-Loccum
Country
Germany
Facility Name
General Practice Meier-Ahrens
City
Rosdorf
Country
Germany
Facility Name
General Practice Woitschek
City
Salzgitter
Country
Germany
Facility Name
General Practice Beulshausen
City
Sattenhausen
Country
Germany
Facility Name
General Practice Schulte
City
Scheeßel
Country
Germany
Facility Name
General Practice Böttcher
City
Schwanewede
Country
Germany
Facility Name
General Practice Albrecht
City
Springe
Country
Germany
Facility Name
General Practice Wolf
City
Uslar
ZIP/Postal Code
37170
Country
Germany
Facility Name
General Practice Schmiemann
City
Verden
Country
Germany
Facility Name
General Practice Annweiler
City
Waake
Country
Germany
Facility Name
General Practice Stegemann
City
Wunstorf
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34111592
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.
Results Reference
derived
PubMed Identifier
29970072
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.
Results Reference
derived
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Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
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