E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
uncomplicated urinary tract infection |
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E.1.1.1 | Medical condition in easily understood language |
uncomplicated urinary tract infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046544 |
E.1.2 | Term | Urinary infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | 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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E.5.2 | 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
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 36 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last follow-up last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |