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Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial

NCT03151603 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2019-11-27

No results posted yet for this study

Summary

It is well known that "over-treatment" of straightforward infections should be avoided as far as possible. Evidence-based data on non antibiotic treatment options for common conditions are therefore needed urgently. This randomised-controlled double blind trial examines whether initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist, reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients presenting with typical UTI symptoms will be included by their GPs and receive randomised either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial antibiotic treatment. Patients record symptom severity and drug intake in a diary and complete a final questionnaire after 28 days.

Conditions

Interventions

DRUG

Arctuvan

application of a herbal drug

DRUG

Fosfomycin

application of an antibiotic drug

DRUG

Placebo to Arctuvan

application of Placebo to Arctuvan

DRUG

Placebo to Fosfomycin

application of Placebo to Fosfomycin

Sponsors & Collaborators

  • University Medical Center Goettingen

    lead OTHER

Principal Investigators

  • Eva Hummers-Pradier, Prof. Dr. · University Medical Center Göttingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-03
Primary Completion
2019-05-19
Completion
2019-06-20

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03151603 on ClinicalTrials.gov