NCT06392282

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

April 25, 2024

Last Update Submit

April 25, 2024

Conditions

Urinary Tract Infections

Keywords

Urinary tract infectionsimmunotherapyMV-140

Outcome Measures

Primary Outcomes (1)

  • UTI episodes

    Change in number of UTI episodes

    1 year

Interventions

MV-140DRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients consulted at Urology clinic with recurrent UTIs

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Santa Maria

Lisbon, Lisbon District, 1649, Portugal

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 30, 2024

Study Start

June 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations

PT(1)