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Observational Follow-up Study of REGATTA (REGATTA II)

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ClinicalTrials.gov Identifier: NCT03176563
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Karsten Gavenis, University Medical Center Goettingen

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

Condition or disease Intervention/treatment
Urinary Tract Infections Drug: Arctuvan Drug: Placebo to Fosfomycin Drug: Fosfomycin Drug: Placebo to Arctuvan

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.

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Study Type : Observational
Estimated Enrollment : 430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Patients With Uncomplicated Urinary Tract Infection Treated With Antibiotics or Herbal Medicinal Product
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fosfomycin

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)




Primary Outcome Measures :
  1. 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

  2. number of pyelonephritis [ Time Frame: 3 months after inclusion in REGATTA ]
    number of pyelonephritis within 3 months after inclusion in REGATTA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
participants of the clinical trial REGATTA
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- no informed consent granted


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176563


Contacts
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Contact: Eva Hummers-Pradier, Prof. Dr. +49 (0) 551 ext 39-22638 Eva.Hummers-Pradier@med.uni-goettingen.de
Contact: ldikó Gágyor, Dr. +49 (0) 551 ext 39-14221 igagyor@gwdg.de

Locations
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Germany
Hausarztpraxis Dr. Raby Active, not recruiting
Achim, Germany
General Practice Aden Recruiting
Braunschweig, Germany
Contact: Ilka Aden, Dr.         
General Practice Scheffer Recruiting
Braunschweig, Germany
Contact: Stephan Scheffer, Dr.         
General Practice Coutelle Recruiting
Bremen, Germany
Contact: Alexander Coutelle, Dr.         
General Practice Schelp Recruiting
Bremen, Germany
Contact: Holger Schelp         
General Practice Dickow Recruiting
Burgwedel, Germany
Contact: Mona Dickow, Dr.         
General Practice Kiwit-Putzer Recruiting
Burgwedel, Germany
Contact: Dorothee Kiwit-Putzer, Dr.         
Praxis Zietz Recruiting
Celle, Germany
Contact: Knud Zietz         
General Practice Kutzsche Recruiting
Emmerthal, Germany
Contact: Tina Kutzsche         
Praxis Dr. Bahr Recruiting
Gieboldehausen, Germany
Contact: Marcel Bahr, Dr. med.         
General Practice Müller Recruiting
Gillersheim, Germany
Contact: Manfred Müller         
Institute of General Medicine, University Medical Center Goettingen Not yet recruiting
Goettigen, Germany, 37075
Contact: Eva Hummers-Pradier, Prof. Dr.         
General Practice Keske Recruiting
Göttingen, Germany
Contact: Wolfgang Keske, Dr.         
General Practice Koch Recruiting
Göttingen, Germany
Contact: Thomas Koch, Dr.         
General Practice Kolb Recruiting
Göttingen, Germany
Contact: Sabine Kolb         
General Practice Lang Recruiting
Göttingen, Germany
Contact: Martin A Lang, Dr.         
General Practice Lückerath Recruiting
Göttingen, Germany
Contact: Marianne Lückerath, Dr.         
Praxisgemeinschaft Jacob / Kling Recruiting
Göttingen, Germany
Contact: Doris Jacob, Dr. med.         
Institute of General Medicine, MHH Hannover Not yet recruiting
Hannover, Germany, 30625
Contact: Jutta Bleidorn, Dr.         
General Practice Barth Recruiting
Hannover, Germany
Contact: Monika Barth, Dr.         
Praxis Dr. Egner Recruiting
Hannover, Germany
Contact: Nadine Egner, Dr. med.         
General Practice Löber Recruiting
Hardegsen, Germany
Contact: Matthias Löber, Dr.         
Gemeinschaftspraxis Dres Schlesier / Eckhardt Recruiting
Heilbad Heiligenstadt, Germany
Contact: Eva-Maria Schlesier         
Gemeinschaftspraxis Hartleb / Stöcking Recruiting
Heilbad Heiligenstadt, Germany
Contact: Gudrun Hartleb         
Praxis Dr. Koch Recruiting
Heilbad Heiligenstadt, Germany
Contact: Constance Koch, Dr. med.         
Praxisgemeinschaft Seitz / Eckert Recruiting
Herzberg Am Harz, Germany
Contact: Moritz Eckert         
General Practice Wilde Recruiting
Hildesheim, Germany
Contact: Elmar Wilde, Dr.         
General Practice Beverungen Recruiting
Höxter, Germany
Contact: Regina Beverungen, Dr.         
Praxisgemeinschaft Stoltz / Raddatz Recruiting
Höxter, Germany
Contact: Michael Stoltz, Dr. med.         
Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch Recruiting
Isernhagen, Germany
Contact: Ursula Kasperczyk, Dr. med.         
General Practice Franz Active, not recruiting
Katlenburg-Lindau, Germany
Praxis Dr. Ohlendorf Recruiting
Langenhagen, Germany
Contact: Jens Ohlendorf, Dr. med.         
General Practice Ertel Recruiting
Langwedel, Germany
Contact: Matthias Ertel         
General Practice Wehrbein Active, not recruiting
Lemforde, Germany
General Practice Lindenblatt Active, not recruiting
Neustadt, Germany
Hausarztzentrum Nörten Recruiting
Nörten-Hardenberg, Germany
Contact: Erhard eberl, Dr. med.         
General Practice Preiskorn Recruiting
Rehburg-Loccum, Germany
Contact: Axel Preiskorn, Dr.         
General Practice Meier-Ahrens Recruiting
Rosdorf, Germany
Contact: Karin Meier-Ahrens, Dr.         
General Practice Woitschek Recruiting
Salzgitter, Germany
Contact: Beate Woitschek         
General Practice Beulshausen Recruiting
Sattenhausen, Germany
Contact: Hella Beulshausen         
General Practice Schulte Recruiting
Scheeßel, Germany
Contact: Peter Schulte, Dr.         
General Practice Böttcher Recruiting
Schwanewede, Germany
Contact: Susanne Böttcher         
General Practice Albrecht Recruiting
Springe, Germany
Contact: Frank Albrecht, Dr.         
General Practice Wolf Active, not recruiting
Uslar, Germany
General Practice Schmiemann Recruiting
Verden, Germany
Contact: Guido Schmiemann, Dr.         
General Practice Annweiler Recruiting
Waake, Germany
Contact: Uta Annweiler, Dr.         
General Practice Stegemann Recruiting
Wunstorf, Germany
Contact: Rolf Stegemann, Dr.         
Sponsors and Collaborators
University Medical Center Goettingen
Investigators
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Principal Investigator: Eva Hummers-Pradier, Prof. Dr. University Medical Center Göttingen

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Responsible Party: Karsten Gavenis, Quality Assurance Staff Unit Clinical Trials, University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT03176563     History of Changes
Other Study ID Numbers: 01970
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karsten Gavenis, University Medical Center Goettingen:
herbal treatment
antibiotics
uncomplicated urinary tract infection

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Fosfomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents