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Clinical Trials/EUCTR2013-004961-14-SE
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

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.

Registry
who.int
Start Date
April 29, 2014
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Kliniken Kärnan Urology Centre

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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