REGATTA II: Observational Follow-up Study of REGATTA

Sponsor

University Medical Center Goettingen (Other)

Overall Status

Completed

CT.gov ID

NCT03176563

Collaborator

(none)

398

Enrollment

Locations

27.6

Actual Duration (Months)

8.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

398 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

Actual Primary Completion Date :

Jul 19, 2019

Actual Study Completion Date :

Aug 20, 2019

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

no informed consent granted

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hausarztpraxis Dr. Raby	Achim	Germany
2	General Practice Aden	Braunschweig	Germany
3	General Practice Scheffer	Braunschweig	Germany
4	General Practice Coutelle	Bremen	Germany
5	General Practice Schelp	Bremen	Germany
6	General Practice Dickow	Burgwedel	Germany
7	General Practice Kiwit-Putzer	Burgwedel	Germany
8	Praxis Zietz	Celle	Germany
9	General Practice Kutzsche	Emmerthal	Germany
10	Praxis Dr. Bahr	Gieboldehausen	Germany
11	General Practice Müller	Gillersheim	Germany
12	Institute of General Medicine, University Medical Center Goettingen	Goettigen	Germany	37075
13	General Practice Keske	Göttingen	Germany
14	General Practice Koch	Göttingen	Germany
15	General Practice Kolb	Göttingen	Germany
16	General Practice Lang	Göttingen	Germany
17	General Practice Lückerath	Göttingen	Germany
18	Praxisgemeinschaft Jacob / Kling	Göttingen	Germany
19	Institute of General Medicine, MHH Hannover	Hannover	Germany	30625
20	General Practice Barth	Hannover	Germany
21	Praxis Dr. Egner	Hannover	Germany
22	General Practice Löber	Hardegsen	Germany
23	Gemeinschaftspraxis Dres Schlesier / Eckhardt	Heilbad Heiligenstadt	Germany
24	Gemeinschaftspraxis Hartleb / Stöcking	Heilbad Heiligenstadt	Germany
25	Praxis Dr. Koch	Heilbad Heiligenstadt	Germany
26	Praxisgemeinschaft Seitz / Eckert	Herzberg Am Harz	Germany
27	General Practice Wilde	Hildesheim	Germany
28	General Practice Beverungen	Höxter	Germany
29	Praxisgemeinschaft Stoltz / Raddatz	Höxter	Germany
30	Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch	Isernhagen	Germany
31	General Practice Franz	Katlenburg-Lindau	Germany
32	Praxis Dr. Ohlendorf	Langenhagen	Germany
33	General Practice Ertel	Langwedel	Germany
34	General Practice Wehrbein	Lemforde	Germany
35	General Practice Lindenblatt	Neustadt	Germany
36	Hausarztzentrum Nörten	Nörten-Hardenberg	Germany
37	General Practice Preiskorn	Rehburg-Loccum	Germany
38	General Practice Meier-Ahrens	Rosdorf	Germany
39	General Practice Woitschek	Salzgitter	Germany
40	General Practice Beulshausen	Sattenhausen	Germany
41	General Practice Schulte	Scheeßel	Germany
42	General Practice Böttcher	Schwanewede	Germany
43	General Practice Albrecht	Springe	Germany
44	General Practice Wolf	Uslar	Germany
45	General Practice Schmiemann	Verden	Germany
46	General Practice Annweiler	Waake	Germany
47	General Practice Stegemann	Wunstorf	Germany