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Observational Follow-up Study of REGATTA

NCT ID: NCT03176563

Last Updated: 2019-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2019-08-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women treated with the herbal drug Uva Ursi

Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm.

Arctuvan

Intervention Type DRUG

application of a herbal drug in the clinical trial REGATTA (NCT03151603)

Placebo to Fosfomycin

Intervention Type DRUG

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.

Fosfomycin

Intervention Type DRUG

application of an antibiotic drug in the clinical trial REGATTA (NCT03151603)

Placebo to Arctuvan

Intervention Type DRUG

application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)

Interventions

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Arctuvan

application of a herbal drug in the clinical trial REGATTA (NCT03151603)

Intervention Type DRUG

Placebo to Fosfomycin

application of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603)

Intervention Type DRUG

Fosfomycin

application of an antibiotic drug in the clinical trial REGATTA (NCT03151603)

Intervention Type DRUG

Placebo to Arctuvan

application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- no informed consent granted
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Goettingen

OTHER

Sponsor Role lead

Responsible Party

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Karsten Gavenis

Quality Assurance Staff Unit Clinical Trials

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Hummers-Pradier, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Göttingen

Locations

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Hausarztpraxis Dr. Raby

Achim, , Germany

Site Status

General Practice Aden

Braunschweig, , Germany

Site Status

General Practice Scheffer

Braunschweig, , Germany

Site Status

General Practice Coutelle

Bremen, , Germany

Site Status

General Practice Schelp

Bremen, , Germany

Site Status

General Practice Dickow

Burgwedel, , Germany

Site Status

General Practice Kiwit-Putzer

Burgwedel, , Germany

Site Status

Praxis Zietz

Celle, , Germany

Site Status

General Practice Kutzsche

Emmerthal, , Germany

Site Status

Praxis Dr. Bahr

Gieboldehausen, , Germany

Site Status

General Practice Müller

Gillersheim, , Germany

Site Status

Institute of General Medicine, University Medical Center Goettingen

Goettigen, , Germany

Site Status

General Practice Keske

Göttingen, , Germany

Site Status

General Practice Koch

Göttingen, , Germany

Site Status

General Practice Kolb

Göttingen, , Germany

Site Status

General Practice Lang

Göttingen, , Germany

Site Status

General Practice Lückerath

Göttingen, , Germany

Site Status

Praxisgemeinschaft Jacob / Kling

Göttingen, , Germany

Site Status

Institute of General Medicine, MHH Hannover

Hanover, , Germany

Site Status

General Practice Barth

Hanover, , Germany

Site Status

Praxis Dr. Egner

Hanover, , Germany

Site Status

General Practice Löber

Hardegsen, , Germany

Site Status

Gemeinschaftspraxis Dres Schlesier / Eckhardt

Heilbad Heiligenstadt, , Germany

Site Status

Gemeinschaftspraxis Hartleb / Stöcking

Heilbad Heiligenstadt, , Germany

Site Status

Praxis Dr. Koch

Heilbad Heiligenstadt, , Germany

Site Status

Praxisgemeinschaft Seitz / Eckert

Herzberg am Harz, , Germany

Site Status

General Practice Wilde

Hildesheim, , Germany

Site Status

General Practice Beverungen

Höxter, , Germany

Site Status

Praxisgemeinschaft Stoltz / Raddatz

Höxter, , Germany

Site Status

Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch

Isernhagen-Süd, , Germany

Site Status

General Practice Franz

Katlenburg-Lindau, , Germany

Site Status

Praxis Dr. Ohlendorf

Langenhagen, , Germany

Site Status

General Practice Ertel

Langwedel, , Germany

Site Status

General Practice Wehrbein

Lemförde, , Germany

Site Status

General Practice Lindenblatt

Neustadt, , Germany

Site Status

Hausarztzentrum Nörten

Nörten-Hardenberg, , Germany

Site Status

General Practice Preiskorn

Rehburg-Loccum, , Germany

Site Status

General Practice Meier-Ahrens

Rosdorf, , Germany

Site Status

General Practice Woitschek

Salzgitter, , Germany

Site Status

General Practice Beulshausen

Sattenhausen, , Germany

Site Status

General Practice Schulte

Scheeßel, , Germany

Site Status

General Practice Böttcher

Schwanewede, , Germany

Site Status

General Practice Albrecht

Springe, , Germany

Site Status

General Practice Wolf

Uslar, , Germany

Site Status

General Practice Schmiemann

Verden an der Aller, , Germany

Site Status

General Practice Annweiler

Waake, , Germany

Site Status

General Practice Stegemann

Wunstorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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01970

Identifier Type: -

Identifier Source: org_study_id

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