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

NCT00894764 | Completed

• 3 other identifiers: SMRU_09-2007Mahidol Approval: MUTM2007/036OXTREC Approval: 031-06
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Childhood Pneumonia; Pneumococcal Carriage

Keywords

Childhood; Pneumonia; Pneumococcal; pneumococcus; Carriage

Study Arms (2)

Routine Follow Up

Monthly nasopharyngeal swab for infant. Seen during acute illness.

Immunology

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Infants born in SMRU antenatal clinic, Maela camp
• Written informed consent from the mother

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator

Study Sites (2)

Shoklo Malaria Research Unit

MaeSod, Changwat Tak, 63110, Thailand

Location

Shoklo Malaria Research Unit

MaeSod, Thailand

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Francois Nosten, MD

  Shoklo Malaria Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: September 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

TH (2)