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

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.

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

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.
Observational

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

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

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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

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
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

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

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.
July 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.
August 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 31, 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.
June 2, 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.
June 5, 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.
  • 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.

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