Observational Follow-up Study of REGATTA (REGATTA II)

University Medical Center Goettingen

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Drug: Arctuvan; Drug: Fosfomycin; Drug: Placebo to Fosfomycin; Drug: Placebo to Arctuvan

Study type: Observational

Funder types: Other

Identifiers

NCT03176563

01970

Details and patient eligibility

About

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

Full 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.

Enrollment: 398 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

398 participants in 2 patient groups

Women treated with the herbal drug Uva Ursi

Description:

Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm.

Treatment:

Drug: Placebo to Fosfomycin

Drug: Arctuvan

Women treated with antibiotics

Description:

Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm.

Treatment:

Drug: Placebo to Arctuvan

Drug: Fosfomycin