MV-140 Efficacy in Recurrent Urinary Tract Infections in a Cohort of Portuguese Adult Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-05-01

Brief Summary

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We will access the efficacy of MV-140 immunotherapy in the prevention of recurrent urinary tract infections in a cohort of Portuguese patients.

Detailed Description

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Urinary tract infections represent a highly frequent and debilitating disease, responsible for an extensive use of antibiotics for treatment and prophylaxis. Non-antibiotic therapies, such as oral vaccines, have been developed, in order to avoid antibiotic use. MV-140 is a sublingual vaccine comprised of 4 inactivated bacteria - E. coli, K. pneumoniae, E. faecalis and Proteus vulgaris. It is approved for the prevention of recurrent UTIs, with promising results in the few published results to date. The efficacy of this tool in the Portuguese population is, however, still unknown. Since the prevalence of pathogens responsible for infections and overall antibiotic use are highly variable worldwide, the results of studies conducted so far are not directly applicable in other regions. Therefore, we designed the present study which aims at assessing the efficacy of immunotherapy with MV-140 In the Portuguese population. It is a prospective observational study, in which patients will be asked to report their condition before and 1 year after therapy.

Conditions

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Urinary Tract Infections

Keywords

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Urinary tract infections immunotherapy MV-140

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MV-140

MV-140 use - sublingual spray approved for recurrent UTI prevention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 3 positive urine culture UTIs in the preceding 12 months
* Ability to understand and fill the informed consent

Exclusion Criteria

I. History of genitourinary tumours II. Urinary lithiasis III. Immunodeficiency IV. Pregnancy V. Simultaneous use of any other urinary tract prevention vaccines or prophylactic antibiotics

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Filipe Abadesso Lopes

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de Santa Maria

Lisbon, Lisbon District, Portugal

Site Status

Countries

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Portugal

Other Identifiers

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48/24

Identifier Type: -

Identifier Source: org_study_id