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

November 26, 2019 updated by: Karsten Gavenis, University Medical Center Goettingen
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
398

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Achim, Germany, 28832
        • Hausarztpraxis Dr. Raby
      • Braunschweig, Germany
        • General Practice Aden
      • Braunschweig, Germany
        • General Practice Scheffer
      • Bremen, Germany
        • General Practice Coutelle
      • Bremen, Germany
        • General Practice Schelp
      • Burgwedel, Germany
        • General Practice Dickow
      • Burgwedel, Germany
        • General Practice Kiwit-Putzer
      • Celle, Germany, 29221
        • Praxis Zietz
      • Emmerthal, Germany
        • General Practice Kutzsche
      • Gieboldehausen, Germany, 37434
        • Praxis Dr. Bahr
      • Gillersheim, Germany
        • General Practice Müller
      • 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, 37073
        • Institute of General Medicine, University Medical Center Goettingen
      • Göttingen, Germany, 37083
        • Praxisgemeinschaft Jacob / Kling
      • Hannover, Germany, 30625
        • Institute of General Medicine, MHH Hannover
      • Hannover, Germany
        • General Practice Barth
      • Hannover, Germany, 30161
        • Praxis Dr. Egner
      • Hardegsen, Germany
        • General Practice Löber
      • Heilbad Heiligenstadt, Germany, 37308
        • Gemeinschaftspraxis Dres Schlesier / Eckhardt
      • Heilbad Heiligenstadt, Germany, 37308
        • Gemeinschaftspraxis Hartleb / Stöcking
      • Heilbad Heiligenstadt, Germany, 37308
        • Praxis Dr. Koch
      • Herzberg, Germany, 37412
        • Praxisgemeinschaft Seitz / Eckert
      • Hildesheim, Germany
        • General Practice Wilde
      • Höxter, Germany
        • General Practice Beverungen
      • Höxter, Germany, 37671
        • Praxisgemeinschaft Stoltz / Raddatz
      • Isernhagen, Germany, 30916
        • Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch
      • Katlenburg-Lindau, Germany
        • General Practice Franz
      • Langenhagen, Germany, 30851
        • Praxis Dr. Ohlendorf
      • Langwedel, Germany
        • General Practice Ertel
      • Lemforde, Germany
        • General Practice Wehrbein
      • Neustadt, Germany
        • General Practice Lindenblatt
      • Nörten-Hardenberg, Germany, 37176
        • Hausarztzentrum Nörten
      • Rehburg-Loccum, Germany
        • General Practice Preiskorn
      • Rosdorf, Germany
        • General Practice Meier-Ahrens
      • Salzgitter, Germany
        • General Practice Woitschek
      • Sattenhausen, Germany
        • General Practice Beulshausen
      • Scheeßel, Germany
        • General Practice Schulte
      • Schwanewede, Germany
        • General Practice Böttcher
      • Springe, Germany
        • General Practice Albrecht
      • Uslar, Germany, 37170
        • General Practice Wolf
      • Verden, Germany
        • General Practice Schmiemann
      • Waake, Germany
        • General Practice Annweiler
      • Wunstorf, Germany
        • General Practice Stegemann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
antibiotic courses
Time Frame: day 0-28
number of antibiotic courses from day 0 to day 28
day 0-28
symptom burden
Time Frame: day 0-7
symptom burden (AUC) from day 0 to day 7
day 0-7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
early relapses
Time Frame: day 0-14
number of early relapses until day 14
day 0-14
recurrent UTI
Time Frame: day 15-28
number of recurrent UTI day 15-28
day 15-28
symptom resolution
Time Frame: day 4 and 7
number of patients with symptom resolution on day 4/7
day 4 and 7
symptom sum score by patients' questionnaire
Time Frame: 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.
day 0-7
symptom burden for dysuria
Time Frame: 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
day 0-7
symptom burden positive urine culture
Time Frame: day 0-7
symptom burden (AUC) day 0-7 of patients with positive urine culture
day 0-7
symptom burden negative urine culture
Time Frame: day 0-7
symptom burden (AUC) day 0-7 of patients with negative urine culture
day 0-7
activity impairment by UTI symptoms, measured as AUC
Time Frame: 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".
day 0-7
painkillers
Time Frame: day 0-7
use of painkillers (Defined Daily Dose (DDD) day 0-7)
day 0-7
patients taking painkillers
Time Frame: day 28
number of patients taking painkillers
day 28
antibiotic use
Time Frame: day 0-28
antibiotic use (defined daily dose (DDD) day 0-28)
day 0-28
UTI related visits
Time Frame: day 0-28
number of UTI related visits day 0-28
day 0-28
UTI related sick leave
Time Frame: day 0-28
number of days of UTI related sick leave day 0-28
day 0-28
patients with poor outcome: temperature
Time Frame: day 0-7
number of patients with temperature >38°C, day 0-7, according to patients´ statement
day 0-7
patients with poor outcome: worsening symptoms
Time Frame: day 28
number of patients with worsening symptoms (impairment in symptom score)
day 28
patients with poor outcome: prolonged symptoms
Time Frame: 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.
day 0-28
pyelonephritis
Time Frame: day 0-28
number of pyelonephritis day 0-28, according to GP´s diagnosis
day 0-28
AE and SAE
Time Frame: day 0-28
number of AE and SAE by system organ class day 0-28
day 0-28
patients with at least 1 AE/ 2 AE
Time Frame: day 28
proportion of patients with at least 1 AE/ 2 AE
day 28
symptom burden for urgency
Time Frame: 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
day 0-7
symptom burden for frequency
Time Frame: 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
day 0-7
symptom burden for lower abdominal pain
Time Frame: 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
day 0-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center Goettingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eva Hummers-Pradier, Prof. Dr., University Medical Center Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01579

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Tract Infections

Clinical Trials on Arctuvan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings