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Urinary Tract InfectionsPhase 4REGATTANCT03151603

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

A Phase 4 study testing Arctuvan and Fosfomycin in people with Urinary Tract Infections, run by University Medical Center Goettingen at 47 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Urinary Tract Infections
What is being tested?
Arctuvan and Fosfomycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
398 participants
Where
47 sitesGermany
Study dates
3 May 2017to 20 Jun 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women (18-75 years) with suspected UTI
  • at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)
  • Written informed consent

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

Germany47 sites

  • Hausarztpraxis Dr. Raby

    Achim, 28832

  • General Practice Aden

    Braunschweig

  • General Practice Scheffer

    Braunschweig

  • General Practice Coutelle

    Bremen

  • General Practice Schelp

    Bremen

  • General Practice Dickow

    Burgwedel

  • General Practice Kiwit-Putzer

    Burgwedel

  • Praxis Zietz

    Celle, 29221

  • General Practice Kutzsche

    Emmerthal

  • Praxis Dr. Bahr

    Gieboldehausen, 37434

  • General Practice Müller

    Gillersheim

  • Institute of General Medicine, University Medical Center Goettingen

    Göttingen, 37073

  • Praxisgemeinschaft Jacob / Kling

    Göttingen, 37083

  • General Practice Keske

    Göttingen

  • General Practice Koch

    Göttingen

  • General Practice Kolb

    Göttingen

  • General Practice Lang

    Göttingen

  • General Practice Lückerath

    Göttingen

  • Praxis Dr. Egner

    Hanover, 30161

  • Institute of General Medicine, MHH Hannover

    Hanover, 30625

  • General Practice Barth

    Hanover

  • General Practice Löber

    Hardegsen

  • Gemeinschaftspraxis Dres Schlesier / Eckhardt

    Heilbad Heiligenstadt, 37308

  • Gemeinschaftspraxis Hartleb / Stöcking

    Heilbad Heiligenstadt, 37308

  • Praxis Dr. Koch

    Heilbad Heiligenstadt, 37308

  • Praxisgemeinschaft Seitz / Eckert

    Herzberg, 37412

  • General Practice Wilde

    Hildesheim

  • Praxisgemeinschaft Stoltz / Raddatz

    Höxter, 37671

  • General Practice Beverungen

    Höxter

  • Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch

    Isernhagen-Süd, 30916

  • General Practice Franz

    Katlenburg-Lindau

  • Praxis Dr. Ohlendorf

    Langenhagen, 30851

  • General Practice Ertel

    Langwedel

  • General Practice Wehrbein

    Lemförde

  • General Practice Lindenblatt

    Neustadt

  • Hausarztzentrum Nörten

    Nörten-Hardenberg, 37176

  • General Practice Preiskorn

    Rehburg-Loccum

  • General Practice Meier-Ahrens

    Rosdorf

  • General Practice Woitschek

    Salzgitter

  • General Practice Beulshausen

    Sattenhausen

  • General Practice Schulte

    Scheeßel

  • General Practice Böttcher

    Schwanewede

  • General Practice Albrecht

    Springe

  • General Practice Wolf

    Uslar, 37170

  • General Practice Schmiemann

    Verden an der Aller

  • General Practice Annweiler

    Waake

  • General Practice Stegemann

    Wunstorf

Other trials in Germany

About this study

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.

Being tested
Arctuvan, Fosfomycin, Placebo to Arctuvan, Placebo to Fosfomycin
Keywords
Uva Ursi, fosfomycin, uncomplicated urinary tract infection of women
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ArctuvanDrug

    application of a herbal drug

  • FosfomycinDrug

    application of an antibiotic drug

  • Placebo to ArctuvanDrug

    application of Placebo to Arctuvan

  • Placebo to FosfomycinDrug

    application of Placebo to Fosfomycin

Study groups in NCT03151603
Study groupRoleWhat they receive
Uva UrsiExperimentalplacebo to fosfomycin: 3 g granules orally 1x1 (day 0) and Uva Ursi: 105 mg (Arctuvan®) 3x2 tablets orally from day 0 for 5 days
Receives: Drug: Arctuvan; Drug: Placebo to Fosfomycin
fosfomycinActive comparatorfosfomycin (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.
Receives: Drug: Fosfomycin; Drug: Placebo to Arctuvan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. antibiotic courses

    number of antibiotic courses from day 0 to day 28

    Measured: day 0-28

  2. symptom burden

    symptom burden (AUC) from day 0 to day 7

    Measured: day 0-7

Secondary outcomes (22)

  1. early relapses

    number of early relapses until day 14

    Measured: day 0-14

  2. recurrent UTI

    number of recurrent UTI day 15-28

    Measured: day 15-28

  3. symptom resolution

    number of patients with symptom resolution on day 4/7

    Measured: day 4 and 7

  4. 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.

    Measured: day 0-7

  5. 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

    Measured: day 0-7

  6. symptom burden positive urine culture

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

    Measured: day 0-7

  7. symptom burden negative urine culture

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

    Measured: day 0-7

  8. 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".

    Measured: day 0-7

  9. painkillers

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

    Measured: day 0-7

  10. patients taking painkillers

    number of patients taking painkillers

    Measured: day 28

  11. antibiotic use

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

    Measured: day 0-28

  12. UTI related visits

    number of UTI related visits day 0-28

    Measured: day 0-28

  13. UTI related sick leave

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

    Measured: day 0-28

  14. patients with poor outcome: temperature

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

    Measured: day 0-7

  15. patients with poor outcome: worsening symptoms

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

    Measured: day 28

  16. 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.

    Measured: day 0-28

  17. pyelonephritis

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

    Measured: day 0-28

  18. AE and SAE

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

    Measured: day 0-28

  19. patients with at least 1 AE/ 2 AE

    proportion of patients with at least 1 AE/ 2 AE

    Measured: day 28

  20. 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

    Measured: day 0-7

  21. 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

    Measured: day 0-7

  22. 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

    Measured: day 0-7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2017
  2. Study start3 May 2017
  3. Primary completion19 May 2019
  4. Study completion20 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03151603
Sponsor's protocol ID
01579
Acronym
REGATTA
Status last verified
Nov 2019
First submitted
10 May 2017
Last updated
27 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34111592

  • 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.

    PubMed 29970072

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Arctuvan and Fosfomycin in people with Urinary Tract Infections, run by University Medical Center Goettingen at 47 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

antibiotic courses (time frame: day 0-28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03151603, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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