Observational Follow-up Study of REGATTA (REGATTA II)

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

Observational Study of Patients With Uncomplicated Urinary Tract Infection Treated With Antibiotics or Herbal Medicinal Product

Observational follow-up study of patients included in the clinical trial REGATTA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A follow-up telephone interview of the participants of the clinical trial REGATTA exploring the occurrence of urinary tract infections, pyelonephritis within a follow-up period of three months after inclusion.

Study Type

Observational

Enrollment (Actual)

398

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
        • 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
        • Praxis Zietz
      • Emmerthal, Germany
        • General Practice Kutzsche
      • Gieboldehausen, Germany
        • Praxis Dr. Bahr
      • Gillersheim, Germany
        • General Practice Müller
      • Goettigen, Germany, 37075
        • Institute of General Medicine, University Medical Center Goettingen
      • 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
        • Praxisgemeinschaft Jacob / Kling
      • Hannover, Germany, 30625
        • Institute of General Medicine, MHH Hannover
      • Hannover, Germany
        • General Practice Barth
      • Hannover, Germany
        • Praxis Dr. Egner
      • Hardegsen, Germany
        • General Practice Löber
      • Heilbad Heiligenstadt, Germany
        • Gemeinschaftspraxis Dres Schlesier / Eckhardt
      • Heilbad Heiligenstadt, Germany
        • Gemeinschaftspraxis Hartleb / Stöcking
      • Heilbad Heiligenstadt, Germany
        • Praxis Dr. Koch
      • Herzberg Am Harz, Germany
        • Praxisgemeinschaft Seitz / Eckert
      • Hildesheim, Germany
        • General Practice Wilde
      • Höxter, Germany
        • General Practice Beverungen
      • Höxter, Germany
        • Praxisgemeinschaft Stoltz / Raddatz
      • Isernhagen, Germany
        • Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch
      • Katlenburg-Lindau, Germany
        • General Practice Franz
      • Langenhagen, Germany
        • Praxis Dr. Ohlendorf
      • Langwedel, Germany
        • General Practice Ertel
      • Lemforde, Germany
        • General Practice Wehrbein
      • Neustadt, Germany
        • General Practice Lindenblatt
      • Nörten-Hardenberg, Germany
        • 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
        • 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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

participants of the clinical trial REGATTA

Description

Inclusion Criteria:

  • participants of the clinical trial REGATTA
  • informed consent to participate in the observational study REGATTA II

Exclusion Criteria:

- no informed consent granted

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women treated with the herbal drug Uva Ursi
Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm.
Drug: Arctuvan
application of a herbal drug in the clinical trial REGATTA (NCT03151603)
Drug: Placebo to Fosfomycin
application of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603)
Women treated with antibiotics
Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm.
Drug: Fosfomycin
application of an antibiotic drug in the clinical trial REGATTA (NCT03151603)
Drug: Placebo to Arctuvan
application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of urinary tract infections
Time Frame: 3 months after inclusion in REGATTA
number of urinary tract infection within 3 months after inclusion in REGATTA
3 months after inclusion in REGATTA
number of pyelonephritis
Time Frame: 3 months after inclusion in REGATTA
number of pyelonephritis within 3 months after inclusion in REGATTA
3 months after inclusion in REGATTA

Collaborators and Investigators

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

Sponsor

University Medical Center Goettingen

Investigators

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

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)

May 3, 2017

Primary Completion (Actual)

July 19, 2019

Study Completion (Actual)

August 20, 2019

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01970

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

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe