Ignite Creation Date:
2024-05-05 @ 9:29 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00894764
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2009-05-06
Brief Title:
The Study of Chest Infections in Infants Living in a Refugee Camp on the Thai-Burmese Border
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Clinical and Microbiological Study of Acute Respiratory Infections in Refugee Infants Living on the Thai-Burmese Border
Status:
COMPLETED
Status Verified Date:
2012-05
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:
ARI
Brief Summary:
This study will follow 1000 refugee infants from birth for two years The aim of the study is to better understand why some children develop infections caused by the bacterium Streptococcus pneumoniae whilst others merely carry this organism asymptomatically at the back of the nose in the nasopharynx The investigators will also define which micro-organisms cause lower respiratory tract infections eg pneumonia in this population in order to implement appropriate interventions eg vaccines Infants will be reviewed monthly and a nasopharyngeal swab will be taken A group of 250 mother-infant pairs will be studied in greater detail to improve our understanding of the frequency and outcomes of nasopharyngeal carriage of Streptococcus pneumoniae Monthly nasopharyngeal swabs will be collected from mothers and infants The investigators will measure the infant immune response to Streptococcus pneumoniae carriage or disease by taking monthly blood samples The investigators will make an assessment of the protective effect of antibodies acquired from the mother during pregnancy by taking blood from the mother and placenta at birth An assessment of pneumococcal carriage in mothers will also be made to determine how frequently the bacterium is transmitted between family members All lower respiratory tract infections will be documented and the causative micro-organisms identified
Detailed Description:
This projects central hypothesis is that acute lower respiratory infections ALRI are a common and significant cause of morbidity and mortality in young children living in Maela refugee camp on the Thai-Burmese border and that this is reflective of the general situation in the developing world Therefore we aim to define the incidence aetiology and outcome of acute lower respiratory infections in this population This will focus on Streptococcus pneumoniae and the factors associated with colonisation and invasive disease
Additional objectives are to
1 Characterise the interaction between bacterial and viral pathogens and disease
2 Examine the dynamics of pneumococcal nasopharyngeal carriage including transmission of strains between infants and their mothers
3 Determine the effect of the non-pathogenic members of the nasopharyngeal flora on colonisation with potential pathogens
4 Examine the role of passively transferred maternal pneumococcal antibodies in subsequent pneumococcal colonisation and disease in the infant
5 Document the development of pneumococcal antibodies in the infants over time and correlate these with pneumococcal carriage and infection episodes
6 Determine the risk factors associated with respiratory infection
7 Characterise the bacteria causing invasive non-respiratory infections
8 Conduct surveillance for influenza and in particular avian influenza A H5N1 infection
Additional objectives are to
1 Characterise the interaction between bacterial and viral pathogens and disease
2 Examine the dynamics of pneumococcal nasopharyngeal carriage including transmission of strains between infants and their mothers
3 Determine the effect of the non-pathogenic members of the nasopharyngeal flora on colonisation with potential pathogens
4 Examine the role of passively transferred maternal pneumococcal antibodies in subsequent pneumococcal colonisation and disease in the infant
5 Document the development of pneumococcal antibodies in the infants over time and correlate these with pneumococcal carriage and infection episodes
6 Determine the risk factors associated with respiratory infection
7 Characterise the bacteria causing invasive non-respiratory infections
8 Conduct surveillance for influenza and in particular avian influenza A H5N1 infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| Mahidol Approval MUTM2007036 | None | None | None |
| OXTREC Approval 031-06 | None | None | None |