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NCT06392282 Clinical Trial

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

Urinary Tract Infections Clinical Trial

Official title:
MV-140 Efficacy in Recurrent Urinary Tract Infections

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06392282
Other study ID # 48/24
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date May 1, 2024

Study information
Verified date April 2024
Source Unidade Local de Saúde Santa Maria
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 104
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Unidade Local de Saúde Santa Maria

Outcome
Type Measure Description Time frame Safety issue
Primary UTI episodes Change in number of UTI episodes 1 year
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