Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392282
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Brief Title:
MV-140 Efficacy in Recurrent Urinary Tract Infections in a Cohort of Portuguese Adult Patients
Sponsor:
Unidade Local de Saúde Santa Maria
Organization:
Unidade Local de Saúde Santa Maria
Study Overview
Official Title:
MV-140 Efficacy in Recurrent Urinary Tract Infections
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None