Objective: To study the relation between PCR positivity of nasopharynx samples and subsequent shedding of infectious airborne viruses during the course of a respiratory infection in children
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Primary end point: Time to negativity of
viruses in the nasopharynx compared to infectious airborne virus in the room
air.
Secondary outcome
Secondary Endpoints: 1) Particle size of infectious viruses captured by viable
impactor air sampling. Particle size will serve as a proxy for route of
transmission. 2) Relation between clinical parameters and the load of
infectious respiratory viruses in the nasopharynx and air
Background summary
SUMMARY
Rationale: Viral respiratory tract infections are a leading cause of morbidity
and mortality worldwide. Most affected are young children. Despite the huge
impact of viral respiratory infections on global health and economy,
transmission routes have not been characterized in great detail. Airborne
transmission of respiratory in viruses occurs via aerosols (<5µm) and/or
respiratory droplets (>5µm). Aerosols can be suspended in the air for a long
period of time. This enables them to travel for meters. Respiratory droplets
are too big to remain in the air for a long period of time and consequently are
not capable of traveling through the air for more than 1 meter. These routes of
transmission may be different between different viruses. In addition, it is
unknown if viruses remain to have the ability to be infectious during the
course of disease. Increased knowledge on the exact mode of transmission may
allow to optimize hospital infection prevention control.
Study objective
Objective: To study the relation between PCR positivity of nasopharynx samples
and subsequent shedding of infectious airborne viruses during the course of a
respiratory infection in children
Study design
Study design: Observational study
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: This study entails minimal harm. Although,
nasopharyngeal swabs may be troublesome for children. This study can only be
carried out in young children because of specific differences in children and
adult immune responses (absence of specific immune response) and disease
phenotype (bronchiolitis vs pneumonia). Data obtained from this study may help
to further strengthen the evidence on how to prevent these (nosocomial)
infection from which the paediatric population at large may benefit.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Admitted for SARI, defined as respiratory tract infection necessitating
hospitalization.
- Tested qRT-PCR positive for RSV, HMPV, PIV and/or Influenza A+B (co-infection
allowed)
- Written Informed consent obtained
For paramyxovirus infections: Children in the age range of new-born until two
years hospitalized in the Sophia Children*s Hospital or Delft. Older children
are expected to have been infected by those viruses and thus have acquired a
pre-existing immune response which will influence the level of replication and
subsequent shedding. Therefore children > 2 years are excluded from this study.
For influenza virus infections: Children in the age range of new-born until
five years hospitalized in the Sophia Children*s Hospital or Delft. It has been
shown that primary infections with influenza viruses occur later than
infections caused by paramyxoviruses. Therefore, children until the age of 5
years are included in this study.
Exclusion criteria
- no written parental informed consent, NB: Co-morbidity is not excluded since
we study real-life viral transmission routes
Design
Recruitment
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 |
|---|---|
| CCMO | NL59998.078.16 |