Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248983
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-01-31
Brief Title:
Transmission Of Respiratory Tract microOrganisms In a School Environment
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Transmission Of Respiratory Tract microOrganisms In a School Environment - the TORTOISE-study
Status:
COMPLETED
Status Verified Date:
2024-07
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:
TORTOISE
Brief Summary:
Through contact with peers in daycare and primaryschool young children play a large role in spreading respiratory pathogens In this study the investigators will investigate this transmission the subsequent colonization and infection dynamics and their association with clinical symptoms and local immune response through dense minimally-invasive sampling This study will allow us a unique insight into the transmission- infection- and colonization-potential of the respiratory pathogens
Detailed Description:
Respiratory tract infections impose a large burden of disease upon the world Pneumonia remains the leading infectious cause of death in children under five worldwide Known causative agents of pneumonia include but are not limited to Spn Haemophilus influenzae HI Moraxella catarrhalis MC and viruses such as the Respiratory Syncytial Virus RSV and the influenza virus These microorganisms are regularly found in the upper respiratory tract URT without causing severe disease Colonization of the URT is thought to be important both for immune boosting and to provide competition for other potential harmful colonizers
This study aims to provide insights into the processes and key host immune and microbiota factors that determine the infection kinetics transmission and development of immunity during such infections Furthermore this study will enable us to closely study the transmission of commonly found microorganisms in an environment that is prone to transmission the close quarters of school classes in which young children and their teachers spend a large part of their time
Research within this specific population risk-group and high transmitting group young children and their teachers is warranted This is due to differences in the pediatric and adult mucosal immune system and infection and transmission dynamics while animal models not being directly translatable to the human situation
In this study the investigators will perform dense longitudinal sampling within groups of closely interacting children and their teachers to study spread and colonization Furthermore by determining a range of biomarkers along with profiling the respiratory microbiome the investigators can look for markers predicting colonization and symptomatic infection
By measuring airobiome through the EDC and air samples collected by a pollensniffer the investigators can measure local exposure to environmental microbes human pathogens and pollen This will allow us to compare immune responses and correlate this with clinical symptoms of RTI
This study aims to provide insights into the processes and key host immune and microbiota factors that determine the infection kinetics transmission and development of immunity during such infections Furthermore this study will enable us to closely study the transmission of commonly found microorganisms in an environment that is prone to transmission the close quarters of school classes in which young children and their teachers spend a large part of their time
Research within this specific population risk-group and high transmitting group young children and their teachers is warranted This is due to differences in the pediatric and adult mucosal immune system and infection and transmission dynamics while animal models not being directly translatable to the human situation
In this study the investigators will perform dense longitudinal sampling within groups of closely interacting children and their teachers to study spread and colonization Furthermore by determining a range of biomarkers along with profiling the respiratory microbiome the investigators can look for markers predicting colonization and symptomatic infection
By measuring airobiome through the EDC and air samples collected by a pollensniffer the investigators can measure local exposure to environmental microbes human pathogens and pollen This will allow us to compare immune responses and correlate this with clinical symptoms of RTI
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8548005823 | REGISTRY | CCMO - toetsingonlinenl | None |