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NCT Number: NCT03151603

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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hausarztpraxis Dr. Raby, Achim, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women (18-75 years) with suspected UTI
  • at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)
  • Written informed consent

Exclusion criteria

  • signs of complicated UTI (e. g. temperature > 38°C, loin tenderness)
  • conditions that may lead to complicated infections (i.e. renal diseases, patients with urinary catheter)
  • pregnancy/ breastfeeding
  • current self-medication with UU preparations e.g. z.B. Cystinol®, Uvalysat®, Arctuvan®
  • antibiotic use in the last 7 days
  • previous UTI in the past 2 weeks
  • history of pyelonephritis
  • contraindications for trial drugs
  • serious diseases
  • inability to understand trial Information
  • current participation in another clinical trial or participation in another clinical trial within the last 4 weeks

Treatment and study plan

Arctuvan

Drug

application of a herbal drug

Fosfomycin

Drug

application of an antibiotic drug

Placebo to Arctuvan

Drug

application of Placebo to Arctuvan

Placebo to Fosfomycin

Drug

application of Placebo to Fosfomycin

Primary outcomes

  1. antibiotic courses

    Time frame: day 0-28

    number of antibiotic courses from day 0 to day 28

  2. symptom burden

    Time frame: day 0-7

    symptom burden (AUC) from day 0 to day 7

Secondary outcomes

  1. early relapses

    Time frame: day 0-14

    number of early relapses until day 14

  2. recurrent UTI

    Time frame: day 15-28

    number of recurrent UTI day 15-28

  3. symptom resolution

    Time frame: day 4 and 7

    number of patients with symptom resolution on day 4/7

  4. symptom sum score by patients' questionnaire

    Time frame: day 0-7

    mean daily symptom sum scores from day 0 to day 7; Each of the symptoms dysuria, urgency, frequency and lower abdominal pain is scored daily on a five point scale from 0 "none" to 4 "very strong" in a patients' questionnaire.

  5. symptom burden for dysuria

    Time frame: day 0-7

    symptom burden (AUC) for dysuria scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7

  6. symptom burden positive urine culture

    Time frame: day 0-7

    symptom burden (AUC) day 0-7 of patients with positive urine culture

  7. symptom burden negative urine culture

    Time frame: day 0-7

    symptom burden (AUC) day 0-7 of patients with negative urine culture

  8. activity impairment by UTI symptoms, measured as AUC

    Time frame: day 0-7

    activity impairment by UTI symptoms (days 0-7), measured as AUC. Impairment by each UTI symptom is scored daily on a five point scale from 0 "none" to 4 "very strong".

  9. painkillers

    Time frame: day 0-7

    use of painkillers (Defined Daily Dose (DDD) day 0-7)

  10. patients taking painkillers

    Time frame: day 28

    number of patients taking painkillers

  11. antibiotic use

    Time frame: day 0-28

    antibiotic use (defined daily dose (DDD) day 0-28)

  12. UTI related visits

    Time frame: day 0-28

    number of UTI related visits day 0-28

  13. UTI related sick leave

    Time frame: day 0-28

    number of days of UTI related sick leave day 0-28

  14. patients with poor outcome: temperature

    Time frame: day 0-7

    number of patients with temperature >38°C, day 0-7, according to patients´ statement

  15. patients with poor outcome: worsening symptoms

    Time frame: day 28

    number of patients with worsening symptoms (impairment in symptom score)

  16. patients with poor outcome: prolonged symptoms

    Time frame: day 0-28

    number of patients with prolonged symptoms (> 7 days), day 0-28. Patients will be followed up until symptom resolution, defined as max. 1 score point on each symptom scale.

  17. pyelonephritis

    Time frame: day 0-28

    number of pyelonephritis day 0-28, according to GP´s diagnosis

  18. AE and SAE

    Time frame: day 0-28

    number of AE and SAE by system organ class day 0-28

  19. patients with at least 1 AE/ 2 AE

    Time frame: day 28

    proportion of patients with at least 1 AE/ 2 AE

  20. symptom burden for urgency

    Time frame: day 0-7

    symptom burden (AUC) for urgency scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7

  21. symptom burden for frequency

    Time frame: day 0-7

    symptom burden (AUC) for frequency scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7

  22. symptom burden for lower abdominal pain

    Time frame: day 0-7

    symptom burden (AUC) for lower abdominal pain scored daily on a five point scale from 0 "none" to 4 "very strong", from day 0 to day 7

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Acronym: REGATTA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 12, 2017
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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