The Study of Chest Infections in Infants Living in a Refugee Camp on the Thai-Burmese Border

Childhood Pneumonia Clinical Trial

— ARI  

Official title:

A Clinical and Microbiological Study of Acute Respiratory Infections in Refugee Infants Living on the Thai-Burmese Border

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894764
• Other study ID #: SMRU_09-2007
• Secondary ID: Mahidol Approval
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: May 4, 2012
• Start date: September 2007
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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 (e.g., pneumonia) in this population in order to implement appropriate interventions (e.g., 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.

Description:

This project's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Infants born in SMRU antenatal clinic, Maela camp

2. Written informed consent from the mother

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Childhood Pneumonia
• Pneumococcal Carriage
• Pneumonia

Locations

Country	Name	City	State
Thailand	Shoklo Malaria Research Unit	MaeSod	Tak
Thailand	Shoklo Malaria Research Unit	MaeSod

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Wellcome Trust

Country where clinical trial is conducted

Thailand,