Childhood PneumoniaARINCT00894764
The Study of Chest Infections in Infants Living in a Refugee Camp on the Thai-Burmese Border
An observational study of Childhood Pneumonia and Pneumococcal Carriage, run by University of Oxford at 2 sites in Thailand.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Pneumonia, Pneumococcal Carriage
- How many people
- 1,000 participants
- Where
- 2 sitesThailand
- Study dates
- Sep 2007to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Infants born in SMRU antenatal clinic, Maela camp
- Written informed consent from the mother
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Shoklo Malaria Research Unit
MaeSod, Changwat Tak, 63110
Shoklo Malaria Research Unit
MaeSod
About this study
Official title: A Clinical and Microbiological Study of Acute Respiratory Infections in Refugee Infants Living on the Thai-Burmese Border
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.
Read the 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:
- Characterise the interaction between bacterial and viral pathogens and disease.
- Examine the dynamics of pneumococcal nasopharyngeal carriage, including transmission of strains between infants and their mothers.
- Determine the effect of the non-pathogenic members of the nasopharyngeal flora on colonisation with potential pathogens.
- Examine the role of passively transferred maternal pneumococcal antibodies in subsequent pneumococcal colonisation and disease in the infant.
- Document the development of pneumococcal antibodies in the infants over time and correlate these with pneumococcal carriage and infection episodes.
- Determine the risk factors associated with respiratory infection.
- Characterise the bacteria causing invasive non-respiratory infections.
- Conduct surveillance for influenza and in particular avian influenza A (H5N1) infection.
- Conditions
- Childhood Pneumonia, Pneumococcal Carriage
- Keywords
- Childhood, Pneumonia, Pneumococcal, pneumococcus, Carriage
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startSep 2007
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood PneumoniaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Francois Nosten, MD, Principal investigator, Shoklo Malaria Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894764
- Sponsor's protocol ID
- SMRU_09-2007
- Other IDs
- Mahidol Approval: MUTM2007/036, OXTREC Approval: 031-06
- Acronym
- ARI
- Status last verified
- May 2012
- First submitted
- 6 May 2009
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical and Microbiological Study of Acute Respiratory Infections in Refugee Infants Living on the Thai-Burmese Border
- ClinicalTrials.gov ID
- NCT00894764
- Acronym / sponsor ID
- ARI / SMRU_09-2007
- Conditions
- Childhood Pneumonia, Pneumococcal Carriage
- Keywords
- Childhood, Pneumonia, Pneumococcal, pneumococcus, Carriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Sep 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Characterise the interaction between bacterial and viral pathogens and disease.
- Examine the dynamics of pneumococcal nasopharyngeal carriage, including transmission of strains between infants and their mothers.
- Determine the effect of the non-pathogenic members of the nasopharyngeal flora on colonisation with potential pathogens.
- Examine the role of passively transferred maternal pneumococcal antibodies in subsequent pneumococcal colonisation and disease in the infant.
- Document the development of pneumococcal antibodies in the infants over time and correlate these with pneumococcal carriage and infection episodes.
- Determine the risk factors associated with respiratory infection.
- Characterise the bacteria causing invasive non-respiratory infections.
- Conduct surveillance for influenza and in particular avian influenza A (H5N1) infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Infants born in SMRU antenatal clinic, Maela camp
- Written informed consent from the mother
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
Related trials for Childhood Pneumonia
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Recruiting
Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia - ToolCAP
Pneumonia, Pneumonia Childhood
Recruiting
Optimising Antibiotic Use for Paediatric Lower Respiratory Tract Infections in Africa
Lower Respiratory Tract Infection (LRTI), Pneumonia
Not yet recruitingEarly Phase 1
3 vs. 5 Days of Amoxicillin for Childhood Pneumonia: An RCT
Community Acquired Pneumonia, Childhood Pneumonia
RecruitingPhase 4
Trial of an AI-enabled Digital Stethoscope to Improve Antibiotic Stewardship
Respiratory Infections in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Nosten, MD principal investigator
Shoklo Malaria Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Pneumonia and Pneumococcal Carriage, run by University of Oxford at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.