Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with bearberry leaf extract

Reducing antibiotic use for uncomplicated urinary tract infection in gen-eral practice by treatment with Uva ursi - a comparative effectiveness trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000477-21-DE

Enrollment

430

Registered

2017-01-10

Start date

2017-03-27

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

uncomplicated urinary tract infection MedDRA version: 20.0 Level: LLT Classification code 10046544 Term: Urinary infection System Organ Class: 100000004862

Interventions

Trade Name: Monuril 3000 mg Granulat Product Name: Monuril 3000 mg Granulat Pharmaceutical Form: Granules for oral solution INN or Proposed INN: FOSFOMYCIN TROMETAMOL Other descriptive name: Monuril 3

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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 - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether antibiotic use can be reduced in women with uncomplicated UTI by treatment with Arctostaphylos uva-ursi (UU, Arctuvan), and conditional antibiotics only in case of persistent or recurrent symptoms, without significant increase in symptoms, recurrent UTI or complications. We compare two therapeutic strategies with respect to the following hypothesis: A Initial treatment with UU/ conditional antibiotic reduces the number of antibiotic courses within 28 days and B Initial treatment with UU/ conditional antibiotic is non-inferior with respect to a 7-day symptom burden as compared to immediate antibiotic use. ;Secondary Objective: not applicable;Primary end point(s): Primary endpoints (two co-primary endpoints): 1) number of antibiotic courses day 0-28, 2) symptom burden (AUC) day 0-7 Symptom burden is the weighted sum of the daily total symptom scores, measured as the area under the curve (AUC) of the total symptom score. The trial result is positive if superiority of initial treatment with UU is demonstrated with reference to the first part of the co-primary outcome and non-inferiority of initial treatment with UU applies with reference to the second part of the co-primary outcome. ;Timepoint(s) of evaluation of this end point: day 0 to day 28 (first co-primary end point) day 0 to day 7 (second co- primary end point)	—

Measure

Time frame

Main Objective: To assess whether antibiotic use can be reduced in women with uncomplicated UTI by treatment with Arctostaphylos uva-ursi (UU, Arctuvan), and conditional antibiotics only in case of persistent or recurrent symptoms, without significant increase in symptoms, recurrent UTI or complications. We compare two therapeutic strategies with respect to the following hypothesis: A Initial treatment with UU/ conditional antibiotic reduces the number of antibiotic courses within 28 days and B Initial treatment with UU/ conditional antibiotic is non-inferior with respect to a 7-day symptom burden as compared to immediate antibiotic use. ;Secondary Objective: not applicable;Primary end point(s): Primary endpoints (two co-primary endpoints): 1) number of antibiotic courses day 0-28, 2) symptom burden (AUC) day 0-7 Symptom burden is the weighted sum of the daily total symptom scores, measured as the area under the curve (AUC) of the total symptom score. The trial result is positive if superiority of initial treatment with UU is demonstrated with reference to the first part of the co-primary outcome and non-inferiority of initial treatment with UU applies with reference to the second part of the co-primary outcome. ;Timepoint(s) of evaluation of this end point: day 0 to day 28 (first co-primary end point) day 0 to day 7 (second co- primary end point)

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary endpoints: - number of early relapses until day 14 - number of recurrent UTI day 15-28 - number of patients with symptom resolution on day 4/7 - mean daily symptom sum scores day 0-7 - symptom burden (AUC) for individual symptoms (dysuria, urgency, frequency, lower abdominal pain) day 0-7 - symptom burden (AUC) day 0-7 of patients with positive urine culture - symptom burden (AUC) day 0-7 of patients with negative urine culture - activity impairment by UTI symptoms (days 0-7) - use of painkillers (DDD day 0-7) - number of patients taking painkillers - antibiotic use (DDD day 0-28) - number of UTI related visits day 0-28 - number of days of UTI related sick leave day 0-28 Assessment of safety: - number of patients with poor outcome: - number of patients with temperature >38°C, day 0-7, according to patients´ Statement - number of patients with worsening symptoms (impairment in symptom score) - 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. - number of pyelonephritis day 0-28, according to GP´s diagnosis - number of AE and SAE by system organ class day 0-28 - proportion of patients with at least 1 AE/ 2 AE ;Timepoint(s) of evaluation of this end point: day 0 to day 28 day 0 to day 14 day 0 to day 7 day 15 to day 28 day 4 day 7	—

Measure

Time frame

Secondary end point(s): Key secondary endpoints: - number of early relapses until day 14 - number of recurrent UTI day 15-28 - number of patients with symptom resolution on day 4/7 - mean daily symptom sum scores day 0-7 - symptom burden (AUC) for individual symptoms (dysuria, urgency, frequency, lower abdominal pain) day 0-7 - symptom burden (AUC) day 0-7 of patients with positive urine culture - symptom burden (AUC) day 0-7 of patients with negative urine culture - activity impairment by UTI symptoms (days 0-7) - use of painkillers (DDD day 0-7) - number of patients taking painkillers - antibiotic use (DDD day 0-28) - number of UTI related visits day 0-28 - number of days of UTI related sick leave day 0-28 Assessment of safety: - number of patients with poor outcome: - number of patients with temperature >38°C, day 0-7, according to patients´ Statement - number of patients with worsening symptoms (impairment in symptom score) - 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. - number of pyelonephritis day 0-28, according to GP´s diagnosis - number of AE and SAE by system organ class day 0-28 - proportion of patients with at least 1 AE/ 2 AE ;Timepoint(s) of evaluation of this end point: day 0 to day 28 day 0 to day 14 day 0 to day 7 day 15 to day 28 day 4 day 7

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Countries

Germany

Contacts

Public ContactDepartment of General Practice

Georg-August-Universität Göttingen, Stiftung Öffentlichen Rechts, Universitätsmedizin Göttingen

Igagyor@gwdg.de+0495513914221

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 6, 2026