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

• Sponsor: University Medical Center Goettingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03151603
• Collaborator: (none)
• Enrollment: 398
• Locations: 47
• Arms: 2
• Actual Duration (Months): 25.6
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Drug: Arctuvan; Drug: Fosfomycin; Drug: Placebo to Arctuvan; Drug: Placebo to Fosfomycin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 398 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
• Actual Study Start Date: May 3, 2017
• Actual Primary Completion Date: May 19, 2019
• Actual Study Completion Date: Jun 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Arctuvan; application of a herbal drug; Drug: Placebo to Fosfomycin; application of Placebo to Fosfomycin
Active Comparator: 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.	Drug: Fosfomycin; application of an antibiotic drug; Drug: Placebo to Arctuvan; application of Placebo to Arctuvan

Outcome Measures

Primary Outcome Measures

1. antibiotic courses [day 0-28]

   number of antibiotic courses from day 0 to day 28

2. symptom burden [day 0-7]

   symptom burden (AUC) from day 0 to day 7

Secondary Outcome Measures

1. early relapses [day 0-14]

   number of early relapses until day 14

2. recurrent UTI [day 15-28]

   number of recurrent UTI day 15-28

3. symptom resolution [day 4 and 7]

   number of patients with symptom resolution on day 4/7

4. symptom sum score by patients' questionnaire [day 0-7]

   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.

5. symptom burden for dysuria [day 0-7]

   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

6. symptom burden positive urine culture [day 0-7]

   symptom burden (AUC) day 0-7 of patients with positive urine culture

7. symptom burden negative urine culture [day 0-7]

   symptom burden (AUC) day 0-7 of patients with negative urine culture

8. activity impairment by UTI symptoms, measured as AUC [day 0-7]

   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".

9. painkillers [day 0-7]

   use of painkillers (Defined Daily Dose (DDD) day 0-7)

10. patients taking painkillers [day 28]

    number of patients taking painkillers

11. antibiotic use [day 0-28]

    antibiotic use (defined daily dose (DDD) day 0-28)

12. UTI related visits [day 0-28]

    number of UTI related visits day 0-28

13. UTI related sick leave [day 0-28]

    number of days of UTI related sick leave day 0-28

14. patients with poor outcome: temperature [day 0-7]

    number of patients with temperature >38°C, day 0-7, according to patients´ statement

15. patients with poor outcome: worsening symptoms [day 28]

    number of patients with worsening symptoms (impairment in symptom score)

16. patients with poor outcome: prolonged symptoms [day 0-28]

    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.

17. pyelonephritis [day 0-28]

    number of pyelonephritis day 0-28, according to GP´s diagnosis

18. AE and SAE [day 0-28]

    number of AE and SAE by system organ class day 0-28

19. patients with at least 1 AE/ 2 AE [day 28]

    proportion of patients with at least 1 AE/ 2 AE

20. symptom burden for urgency [day 0-7]

    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

21. symptom burden for frequency [day 0-7]

    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

22. symptom burden for lower abdominal pain [day 0-7]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hausarztpraxis Dr. Raby	Achim		Germany	28832
2	General Practice Aden	Braunschweig		Germany
3	General Practice Scheffer	Braunschweig		Germany
4	General Practice Coutelle	Bremen		Germany
5	General Practice Schelp	Bremen		Germany
6	General Practice Dickow	Burgwedel		Germany
7	General Practice Kiwit-Putzer	Burgwedel		Germany
8	Praxis Zietz	Celle		Germany	29221
9	General Practice Kutzsche	Emmerthal		Germany
10	Praxis Dr. Bahr	Gieboldehausen		Germany	37434
11	General Practice Müller	Gillersheim		Germany
12	Institute of General Medicine, University Medical Center Goettingen	Göttingen		Germany	37073
13	Praxisgemeinschaft Jacob / Kling	Göttingen		Germany	37083
14	General Practice Keske	Göttingen		Germany
15	General Practice Koch	Göttingen		Germany
16	General Practice Kolb	Göttingen		Germany
17	General Practice Lang	Göttingen		Germany
18	General Practice Lückerath	Göttingen		Germany
19	Praxis Dr. Egner	Hannover		Germany	30161
20	Institute of General Medicine, MHH Hannover	Hannover		Germany	30625
21	General Practice Barth	Hannover		Germany
22	General Practice Löber	Hardegsen		Germany
23	Gemeinschaftspraxis Dres Schlesier / Eckhardt	Heilbad Heiligenstadt		Germany	37308
24	Gemeinschaftspraxis Hartleb / Stöcking	Heilbad Heiligenstadt		Germany	37308
25	Praxis Dr. Koch	Heilbad Heiligenstadt		Germany	37308
26	Praxisgemeinschaft Seitz / Eckert	Herzberg		Germany	37412
27	General Practice Wilde	Hildesheim		Germany
28	Praxisgemeinschaft Stoltz / Raddatz	Höxter		Germany	37671
29	General Practice Beverungen	Höxter		Germany
30	Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch	Isernhagen		Germany	30916
31	General Practice Franz	Katlenburg-Lindau		Germany
32	Praxis Dr. Ohlendorf	Langenhagen		Germany	30851
33	General Practice Ertel	Langwedel		Germany
34	General Practice Wehrbein	Lemforde		Germany
35	General Practice Lindenblatt	Neustadt		Germany
36	Hausarztzentrum Nörten	Nörten-Hardenberg		Germany	37176
37	General Practice Preiskorn	Rehburg-Loccum		Germany
38	General Practice Meier-Ahrens	Rosdorf		Germany
39	General Practice Woitschek	Salzgitter		Germany
40	General Practice Beulshausen	Sattenhausen		Germany
41	General Practice Schulte	Scheeßel		Germany
42	General Practice Böttcher	Schwanewede		Germany
43	General Practice Albrecht	Springe		Germany
44	General Practice Wolf	Uslar		Germany	37170
45	General Practice Schmiemann	Verden		Germany
46	General Practice Annweiler	Waake		Germany
47	General Practice Stegemann	Wunstorf		Germany

Sponsors and Collaborators

• University Medical Center Goettingen

Investigators

• Principal Investigator: Eva Hummers-Pradier, Prof. Dr., University Medical Center Göttingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karsten Gavenis, Quality Assurance Staff Unit Clinical Trials, University Medical Center Goettingen
• ClinicalTrials.gov Identifier: NCT03151603
• Other Study ID Numbers: 01579
• First Posted: May 12, 2017
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Karsten Gavenis, Quality Assurance Staff Unit Clinical Trials, University Medical Center Goettingen: Uva Ursi; fosfomycin; uncomplicated urinary tract infection of women
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Fosfomycin

Study Results

No Results Posted as of Nov 27, 2019