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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