EUCTR2013-004961-14-SE
Active, not recruiting
Phase 1
Pilot study to investigate the mode of action (MoA) of Uro-Vaxom® on a molecular level in pre-menopausal women suffering from recurrent urinary tract infections (rUTI) - OM-89 Modes of action study in women with recurrent UTI
Kliniken Kärnan Urology Centre0 sites10 target enrollmentApril 29, 2014
DrugsUro-Vaxom
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kliniken Kärnan Urology Centre
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Otherwise healthy pre\-menopausal females who are naïve to OM\-89 prophylaxis (\>18 years old) suffering from recurrent non\-febrile lower UTI (\=3 UTIs in previous year. UTI episodes should be documented by repeated cultures and at least 2 clinical symptoms and there should be a minimum interval of 2 weeks between each infection episode).
- •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 10
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Diabetes mellitus type 1
- •\- Poorly controlled diabetes mellitus type 2
- •\- Treatment of malignant diseases in the past two years
- •\- Corticosteroid treatment
- •\- Auto\-immune disorders
- •\- Immune deficiency or immune compromised conditions
- •\- Multiple sclerosis
- •\- Women: pregnant or intending to be pregnant and not using acceptable contraceptives, menopausal status
- •\- Previous OM\-89 treatment
Outcomes
Primary Outcomes
Not specified
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