No registrations found.
Source
Brief title
Health condition
Respiratory tract infections
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
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
a) To validate the use of synthetic absorptive matrices (SAM) for detection of other respiratory pathogens versus NPS and saliva.
b) To assess dynamics of upper respiratory tract (URT) infection/colonisation for other pathogens.
c) To examine the relationship between local and systemic immune responses measured by SAM and URT infection/colonisation dynamics.
d) To define effect of incoming bacteria/viruses on microbiota and vice versa.
e) To measure host and microbial parameters associated with local immune boosting during colonisation/infection.
f) Associate common cold symptoms with URT colonisation/infection and related host responses.
g) Measure transmission between children and parents and immune responses in parents.
Background summary
Respiratory tract infections (RTI) are a major cause of morbidity in young children in high-income countries and the major cause of mortality in developing countries. The aetiology of lower RTI (LRTI) is often polymicrobial, involving well-known viral or bacterial pathogens or combinations of both. LRTI pathogens all originate in the nasopharynx. Usually these bacteria are regular residents of the nasopharynx of asymptomatic individuals and live there together with other presumed harmless commensals, without causing disease. Together they are a complex bacterial community, called the nasopharyngeal (NP) bacterial microbiome. In addition to bacteria, viruses are also found in the nasopharynx during respiratory tract infection and in asymptomatic individuals. These infections are important for transmission, intermediate step to disease and boost immune responses. Such infections are extremely dynamic, but very few studies have been able to characterize them due to the discomfort related to classical sampling methods, such as nasopharyngeal swabs (NPS). We recently validated the use of minimally-invasive nasal sampling methods that can be done at home for the study of host and microbial parameters in adults and children. In this study we will focus on the daily microbial and immunological composition of the nasopharynx during health in relation to symptoms.
Study objective
Our hypothesis is that children who become colonized with Streptococcus pneumoniae have low levels of PS-specific memory B cells at the time of exposure.
Study design
Daily sampling for 28 consecutive days
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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9846 |
CCMO | NL77975.058.21 |