To determine the expression of inhibitory receptors on immune competent cells in patients and healthy controls
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: (1) expression of inhibitory receptors in
peripheral blood and tracheal aspirate, (2) concentration of soluble inhibitory
receptors in plasma, nasopharyngeal aspirates and urine.
Secondary outcome
A secondary objective is to study changes in bacterial carriership during the
course of infection, which will be studied in nasopharyngeal swabs on admission
and 1 month later.
Background summary
Respiratory syncytial virus bronchiolitis is the most frequent cause of
hospitalization during infancy. The pathogenesis is not well understood. No
effective treatment is available. In literature, is has been suggested that
disease is the consequence of lack of immune regulation. The hypothesis tested
in this study is that RSV bronchiolitis is associated with expression of
inhibitory receptors.
Study objective
To determine the expression of inhibitory receptors on immune competent cells
in patients and healthy controls
Study design
Observational case-cohort study
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
A single venapuncture will be taken, which is unlikely to be part of normal
care. Drawing venous blood is moderately painful.
Nasopharyngeal aspiration is a non-invasive technique where mucus is suctioned
from the nose. The burden for the patient is low, consisting of discomfort
during less than 10 seconds. Most children admitted to the hospital for
respiratory illness during the winter season undergo this diagnostic procedure
to determine if they are RSV positive or negative. Also due to obstruction of
the nose by mucus the nose will be suctioned frequently in LRTI patients.
Medical staff is experienced with this technique. No complications have been
described. For children from control population who are not ventilated and
without LRTI, nasopharyngeal aspiration is not required for patients not
participating in this study.
Nasopharyngeal swab is a non-invasive technique where mucus is swabbed from the
nose. The burden for the patient is even lower than nasopharyngeal aspiration,
because the duration is less than 10 seconds and the the swab is very soft.
Medical staff is experienced with this technique. No complications have been
described.
Urine will be collected by a simple bag. This can be used in both boys and
girls. Urine collection is associated with low burden for the patient.
Tracheal aspirate in ventilated RSV patients and ventilated controls will only
be taken as part of routine care
Possible benefit:
There is no clear clinical benefit for the infants participating in this
proposed study.
POB 85090, Kamer E4.133.1
3508 AB Utrecht
NL
POB 85090, Kamer E4.133.1
3508 AB Utrecht
NL
Listed location countries
Age
Inclusion criteria
Children under the age of 13 months that require mechanical ventilation for symptoms of respiratory syncytial virus (RSV) lower respiratory infection, known as the index group. In addition, 3 control populations will included: hospitalized RSV patients who do not require mechanical ventilation, ventilated control patients without infection and non-ventilated control patients without infection
Exclusion criteria
Severe comorbidity, such as any organ dysfunction
Any Syndromal abnormality, such as Down Syndrome
Any other infection during past 14 days
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 | NL33225.041.10 |