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

Active, not recruiting

• Conditions: Urinary Tract Infections

• Registration Number: NCT06392282
• Lead Sponsor: Unidade Local de Saúde Santa Maria

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 104

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
UTI episodes	1 year	Change in number of UTI episodes