Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
Evaluation of the Prevalence of E Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection
Sponsor:
PENTA Foundation
Organization:
PENTA Foundation
Study Overview
Official Title:
Evaluation of the Prevalence of E Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection in Europe
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
rUTI
Brief Summary:
This is a multicentre observational epidemiological study in which infants within the first 3 months of life with UTI and children aged 4 months with r-UTI will be recruited from nephrology emergency departments and primary care in European countries
Detailed Description:
This is an international multicenter observational cross-sectional epidemiological study
Study participants will undergo a screening phase and will be checked for study eligible and inclusionexclusion criteria at study entry No other visits will be conducted other than the first evaluation The study will be conducted across up to 26 participating sites in Europe including nephrology departments paediatric emergency departments and primary care centers Specifically sites located more in Western and Eastern Europe will be involved in the study In total 600 participants with rUTI UTI will be included in this study with approximately 200 participants for each age group from 0 months to 3 years of age from 3 to 12 years of age from 12 to 18 years of age
Study participants will undergo a screening phase and will be checked for study eligible and inclusionexclusion criteria at study entry No other visits will be conducted other than the first evaluation The study will be conducted across up to 26 participating sites in Europe including nephrology departments paediatric emergency departments and primary care centers Specifically sites located more in Western and Eastern Europe will be involved in the study In total 600 participants with rUTI UTI will be included in this study with approximately 200 participants for each age group from 0 months to 3 years of age from 3 to 12 years of age from 12 to 18 years of age
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?:
None
Is an FDA AA801 Violation?:
None