MedPath

SAMSAM

Recruiting
Conditions
Respiratory tract infections
Registration Number
NL-OMON21999
Lead Sponsor
eiden University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

a) Child aged 1-5 years of age attending day care, peuterspeelzaal or school at least 2 (half) days a week.
b) Parents ability and willingness to adhere to protocol-specified procedures, including availability of a freezer at home to store samples. This does not include donation of saliva by parents themselves, which is related to a secondary endpoint.
c) Written informed consent will be obtained from all legal representatives, for example both parents.

Exclusion Criteria

a) History of respiratory tract infections requiring hospitalization.
b) Current use of antibiotics, or antibiotics use in past four weeks.
c) Use of immune-altering medication (such as steroids, including inhaled corticosteroid).
d) History of severe concomitant disease (severe congenital heart disease, bronchopulmonary dysplasia, prematurity <32 weeks, cystic fibrosis, sickle cell disease, congenital or acquired immunodeficiency disorders, cardiovascular disease, neuromuscular disorders, oncology patients or major congenital anomalies).

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Assess dynamics of pneumococcal colonisation using daily nasal sampling and the association of this with levels of pre-existing polysaccharide specific memory B cells.
Secondary Outcome Measures
NameTimeMethod
a) To validate the use of synthetic absorptive matrices (SAM) for detection of other respiratory pathogens versus NPS and saliva. <br>b) To assess dynamics of upper respiratory tract (URT) infection/colonisation for other pathogens. <br>c) To examine the relationship between local and systemic immune responses measured by SAM and URT infection/colonisation dynamics. <br>d) To define effect of incoming bacteria/viruses on microbiota and vice versa. <br>e) To measure host and microbial parameters associated with local immune boosting during colonisation/infection. <br>f) Associate common cold symptoms with URT colonisation/infection and related host responses. <br>g) Measure transmission between children and parents and immune responses in parents.
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