Observational Follow-up Study of REGATTA

Completed

• Conditions: Urinary Tract Infections
• Interventions: Drug: Arctuvan; Drug: Fosfomycin; Drug: Placebo to Fosfomycin; Drug: Placebo to Arctuvan

• Registration Number: NCT03176563
• Lead Sponsor: University Medical Center Goettingen

Brief Summary

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

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 Timeline

• Study Start: 2017-05-03
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Primary Completion: 2019-07-19
• Study Completion: 2019-08-20
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 398

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women treated with the herbal drug Uva Ursi	Arctuvan	Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm.
Women treated with the herbal drug Uva Ursi	Placebo to Fosfomycin	Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm.
Women treated with antibiotics	Placebo to Arctuvan	Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm.
Women treated with antibiotics	Fosfomycin	Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm.

Primary Outcome Measures

Name	Time	Method
number of urinary tract infections	3 months after inclusion in REGATTA	number of urinary tract infection within 3 months after inclusion in REGATTA
number of pyelonephritis	3 months after inclusion in REGATTA	number of pyelonephritis within 3 months after inclusion in REGATTA

Trial Locations

Locations (47)

General Practice Koch; 🇩🇪 Göttingen, Germany

General Practice Kolb; 🇩🇪 Göttingen, Germany

Institute of General Medicine, MHH Hannover; 🇩🇪 Hannover, Germany

General Practice Schmiemann; 🇩🇪 Verden, Germany

General Practice Scheffer; 🇩🇪 Braunschweig, Germany

Hausarztpraxis Dr. Raby; 🇩🇪 Achim, Germany

General Practice Aden; 🇩🇪 Braunschweig, Germany

General Practice Schelp; 🇩🇪 Bremen, Germany

General Practice Kiwit-Putzer; 🇩🇪 Burgwedel, Germany

General Practice Coutelle; 🇩🇪 Bremen, Germany

General Practice Dickow; 🇩🇪 Burgwedel, Germany

Praxis Zietz; 🇩🇪 Celle, Germany

General Practice Kutzsche; 🇩🇪 Emmerthal, Germany

General Practice Müller; 🇩🇪 Gillersheim, Germany

General Practice Keske; 🇩🇪 Göttingen, Germany

Praxis Dr. Bahr; 🇩🇪 Gieboldehausen, Germany

Institute of General Medicine, University Medical Center Goettingen; 🇩🇪 Goettigen, Germany

General Practice Lang; 🇩🇪 Göttingen, Germany

Praxisgemeinschaft Jacob / Kling; 🇩🇪 Göttingen, Germany

General Practice Lückerath; 🇩🇪 Göttingen, Germany

General Practice Barth; 🇩🇪 Hannover, Germany

Praxis Dr. Egner; 🇩🇪 Hannover, Germany

Gemeinschaftspraxis Dres Schlesier / Eckhardt; 🇩🇪 Heilbad Heiligenstadt, Germany

General Practice Löber; 🇩🇪 Hardegsen, Germany

Praxis Dr. Koch; 🇩🇪 Heilbad Heiligenstadt, Germany

Gemeinschaftspraxis Hartleb / Stöcking; 🇩🇪 Heilbad Heiligenstadt, Germany

Praxisgemeinschaft Seitz / Eckert; 🇩🇪 Herzberg Am Harz, Germany

General Practice Wilde; 🇩🇪 Hildesheim, Germany

General Practice Beverungen; 🇩🇪 Höxter, Germany

Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch; 🇩🇪 Isernhagen, Germany

Praxisgemeinschaft Stoltz / Raddatz; 🇩🇪 Höxter, Germany

General Practice Wehrbein; 🇩🇪 Lemforde, Germany

General Practice Franz; 🇩🇪 Katlenburg-Lindau, Germany

Praxis Dr. Ohlendorf; 🇩🇪 Langenhagen, Germany

General Practice Ertel; 🇩🇪 Langwedel, Germany

General Practice Lindenblatt; 🇩🇪 Neustadt, Germany

General Practice Preiskorn; 🇩🇪 Rehburg-Loccum, Germany

General Practice Beulshausen; 🇩🇪 Sattenhausen, Germany

General Practice Meier-Ahrens; 🇩🇪 Rosdorf, Germany

Hausarztzentrum Nörten; 🇩🇪 Nörten-Hardenberg, Germany

General Practice Woitschek; 🇩🇪 Salzgitter, Germany

General Practice Schulte; 🇩🇪 Scheeßel, Germany

General Practice Böttcher; 🇩🇪 Schwanewede, Germany

General Practice Albrecht; 🇩🇪 Springe, Germany

General Practice Wolf; 🇩🇪 Uslar, Germany

General Practice Annweiler; 🇩🇪 Waake, Germany

General Practice Stegemann; 🇩🇪 Wunstorf, Germany