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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03176563
Other study ID # 01970
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2017
Est. completion date August 20, 2019

Study information

Verified date November 2019
Source University Medical Center Goettingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 398
Est. completion date August 20, 2019
Est. primary completion date July 19, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Arctuvan
application of a herbal drug in the clinical trial REGATTA (NCT03151603)
Placebo to Fosfomycin
application of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603)
Fosfomycin
application of an antibiotic drug in the clinical trial REGATTA (NCT03151603)
Placebo to Arctuvan
application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of urinary tract infections number of urinary tract infection within 3 months after inclusion in REGATTA 3 months after inclusion in REGATTA
Primary number of pyelonephritis number of pyelonephritis within 3 months after inclusion in REGATTA 3 months after inclusion in REGATTA
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