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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894764
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : May 7, 2012
Wellcome Trust
Information provided by (Responsible Party):
University of Oxford

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 (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.

Condition or disease
Childhood Pneumonia Pneumococcal Carriage

Detailed 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.

Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical and Microbiological Study of Acute Respiratory Infections in Refugee Infants Living on the Thai-Burmese Border
Study Start Date : September 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Routine Follow Up
Monthly nasopharyngeal swab for infant. Seen during acute illness.
Monthly nasopharyngeal swab for mother and infant. Serum sample taken from Infant. Seen during acute illness.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Maela is a densely populated camp predominantly inhabited by refugees of the Karen ethnic group. It is located in hills adjoining the Burmese border 50 km north of Mae Sot. It is the largest of the camps on the Thai-Burmese border, housing around one-third of the total refugee population. Maela has a population of approximately 43,000 people, of which 20% are females of child bearing age. Women presenting for antenatal care at SMRU's clinic will be asked to take part in the study.

Inclusion Criteria:

  1. Infants born in SMRU antenatal clinic, Maela camp
  2. Written informed consent from the mother

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00894764

Shoklo Malaria Research Unit
MaeSod, Tak, Thailand, 63110
Shoklo Malaria Research Unit
MaeSod, Thailand
Sponsors and Collaborators
University of Oxford
Wellcome Trust
Principal Investigator: Francois Nosten, MD Shoklo Malaria Research Unit

Responsible Party: University of Oxford Identifier: NCT00894764     History of Changes
Other Study ID Numbers: SMRU_09-2007
Mahidol Approval: MUTM2007/036
OXTREC Approval: 031-06
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by University of Oxford:

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections