Observational Follow-up Study of REGATTA
Overview
Observational follow-up study of patients included in the clinical trial REGATTA.
Full Title of Study: “Observational Study of Patients With Uncomplicated Urinary Tract Infection Treated With Antibiotics or Herbal Medicinal Product”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: July 19, 2019
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.
Interventions
- 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)
- 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)
Arms, Groups and Cohorts
- 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.
Clinical Trial Outcome Measures
Primary Measures
- 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
- number of pyelonephritis
- Time Frame: 3 months after inclusion in REGATTA
- number of pyelonephritis within 3 months after inclusion in REGATTA
Participating in This Clinical Trial
Inclusion Criteria
- participants of the clinical trial REGATTA – informed consent to participate in the observational study REGATTA II Exclusion Criteria:
- no informed consent granted
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University Medical Center Goettingen
- Provider of Information About this Clinical Study
- Principal Investigator: Karsten Gavenis, Quality Assurance Staff Unit Clinical Trials – University Medical Center Goettingen
- Overall Official(s)
- Eva Hummers-Pradier, Prof. Dr., Principal Investigator, University Medical Center Göttingen
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