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

MV-140 Efficacy in Recurrent Urinary Tract Infections

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

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Tract Infections

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 Type: Observational
• Enrollment (Estimated): 104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients consulted at Urology clinic with recurrent UTIs

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UTI episodes	Change in number of UTI episodes	1 year

Collaborators and Investigators

• Sponsor: Unidade Local de Saúde Santa Maria

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: immunotherapy; Urinary tract infections; MV-140
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: 48/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD might be anonymously shared with suitable fellow researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No