Uncomplicated recurrent urinary tract infections MedDRA version: 9.1 Level: LLT Classification code 10038140 Term: Recurrent urinary tract infection
Conditions
Interventions
Trade Name: Uro-Vaxom
Pharmaceutical Form: Capsule*
Current Sponsor code: OM-89
Other descriptive name: Escherichia Coli, Lyophilised
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
OM PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female between 18 and 73 years. - History of recurrent UTI (at least 3 documented UTIs in the previous year). - Women suffering from an acute uncomplicated UTI at the screening visit with clinical symptoms dysuria (burning pain at micturition), pollakisuria (frequency) and urgency to urinate*and without symptoms at the enrolment visit (V2). - Positive results of microbiological urine analysis (³ 105 cfu/mL) and identification of bacteria at the screening visit (V1) and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Known complicated urinary tract infections (functional and structural abnormalities within the urinary tract), renal disease, pyelonephritis or obstructive morphological changes. - Acute UTI at Visit 2(Enrolment Visit). - Persistent urinary tract infections (> 14 days). - Indwelling urinary catheter. - Paraplegic patients with known neurogenic bladder dysfunction. - Fever equal/higher than 38.0 °C at the enrolment visit. - Auto-immune disease and other systemic diseases related to immune system disorders (including diabetes mellitus). - Pregnant patients, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (Oral Contraceptiva, Intra Uterine Device, Abstinence, Sterilisation) - Major surgical procedure within the last 3 months prior to study start. - Participation in another clinical trial within the last 3 months prior to study start and during the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirmation of the efficacy and safety of URO-VAXOM® in comparison to placebo within 6 months after enrolment;Secondary Objective: To compare the efficacy and safety of URO-VAXOM® versus standard prophylaxis (Month 7 to Month 12);Primary end point(s): The primary efficacy variable of the study is the mean rate of events of acute uncomplicated UTIs within 6 months after enrolment (Months 1-6), i.e. mean of the total number of UTIs per patient | — |
Countries
Austria, Germany
Outcome results
None listed