Observational Follow-up Study of REGATTA
REGATTA II
Observational Study of Patients With Uncomplicated Urinary Tract Infection Treated With Antibiotics or Herbal Medicinal Product
1 other identifier
observational
398
1 country
47
Brief Summary
Observational follow-up study of patients included in the clinical trial REGATTA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Typical duration for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2017
CompletedFirst Submitted
Initial submission to the registry
May 31, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2019
CompletedNovember 27, 2019
November 1, 2019
2.2 years
May 31, 2017
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
number of urinary tract infections
number of urinary tract infection within 3 months after inclusion in REGATTA
3 months after inclusion in REGATTA
number of pyelonephritis
number of pyelonephritis within 3 months after inclusion in REGATTA
3 months after inclusion in REGATTA
Study Arms (2)
Women treated with the herbal drug Uva Ursi
Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm.
Women treated with antibiotics
Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm.
Interventions
application of a herbal drug in the clinical trial REGATTA (NCT03151603)
application of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603)
application of an antibiotic drug in the clinical trial REGATTA (NCT03151603)
application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)
Eligibility Criteria
participants of the clinical trial REGATTA
You may qualify if:
- participants of the clinical trial REGATTA
- informed consent to participate in the observational study REGATTA II
You may not qualify if:
- \- no informed consent granted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
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, 37075, 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
Institute of General Medicine, MHH Hannover
Hanover, 30625, Germany
General Practice Barth
Hanover, Germany
Praxis Dr. Egner
Hanover, 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-Süd, Germany
General Practice Franz
Katlenburg-Lindau, Germany
Praxis Dr. Ohlendorf
Langenhagen, Germany
General Practice Ertel
Langwedel, Germany
General Practice Wehrbein
Lemförde, 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 an der Aller, Germany
General Practice Annweiler
Waake, Germany
General Practice Stegemann
Wunstorf, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Hummers-Pradier, Prof. Dr.
University Medical Center Göttingen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Quality Assurance Staff Unit Clinical Trials
Study Record Dates
First Submitted
May 31, 2017
First Posted
June 5, 2017
Study Start
May 3, 2017
Primary Completion
July 19, 2019
Study Completion
August 20, 2019
Last Updated
November 27, 2019
Record last verified: 2019-11