Primary: to determine the percentage of ILI attributable to influenza virus in elderly individuals >= 60 years of age Secondary: to determine the relative contribution of influenza viral subtypesSecondary: to determine humoral immune response to…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: presence of influenza A and B virus in nasal swab during ILI episodes
Secondary outcome
Secondary: subtyping of influenza viruses in case of influenza infection
Secondary: antibody levels to influenza virus
Secondary: presence of viral (other than influenza A or B) and bacterial
microorganisms in nasal and transoral nasopharyngeal swabs respectively after
reporting of ILI by the participants during ILI episodes and 8 weeks later. The
following micro-organisms will at least be screened by PCR or conventional
bacterial culture: human parainfluenza virus, RSV A and B, adenovirus,
coronavirus, hMPV, human rhinovirus, bocavirus and polyomaviruses, Mycoplasma
pneumoniae, S. pneumoniae, H. influenzae,M. catarrhalis, S. aureus,, N.
meningitidis and B. pertussis. Other pathogens might be added if diagnosis is
still inconclusive or if other pathogens become prevalent during this season.
Additional pneumococcal serotyping may be performed by multiserotype PCR.
Secondary: presence of S. pneumoniae in saliva
Secondary: antibody levels towards viral and bacterial pathogens present in the
swabs as identified by PCR or bacterial culture.
Secondary: a SF-36 (short-form health survey) questionnaire at baseline.
Background summary
The general public is questioning the effectiveness of seasonal influenza
vaccination in elderly as a result of the general impression that all
influenza-like illness (ILI) is caused by an influenza virus infection.
However, several pathogens, both viral and bacterial, can cause ILI. A better
understanding of the percentage of ILI caused by an influenza virus infection
and the contribution of other respiratory viruses or involvement of bacteria
will allow a better appreciation of seasonal influenza vaccines. In addition,
information will be collected on the occurrence of viral and bacterial
co-infections.
Study objective
Primary: to determine the percentage of ILI attributable to influenza virus in
elderly individuals >= 60 years of age
Secondary: to determine the relative contribution of influenza viral subtypes
Secondary: to determine humoral immune response to influenza virus
Secondary: to identify which microorganisms (viral and bacterial) present in
nose and nasopharynx of elderly suffering from ILI are potential other causes
for ILI
Secondary: to determine humoral immune response towards the potential pathogens
based on culture/PCR data
Secondary: to gain insight in the influence of viral presence on
co-colonization of well-known respiratory bacterial pathogens like S.
pneumoniae, H. influenza, M. catarrhalis, S. aureus in elderly by comparing
colonization during ILI and after recovery.
Secondary: to compare detection of pneumococcal detection in nasopharyngeal
swabs with saliva
Exploratory: to evaluate whether differences can be found in incidence of
influenza virus detection between subjects who have received the seasonal
influenza vaccine 2011-2012 or who did not receive the seasonal influenza
vaccine 2011-2012.
Exploratory: to evaluate whether there is a difference in the general physical
and mental health condition as assessed by SF-36 questionnaire between the
subjects that report with ILI and the whole study population
Study design
Observational cross-sectional study without an investigational medicinal
product but with invasive measurements.
Study burden and risks
The burden associated with participation are reporting of ILI, and collection
of a nasal swab and a transoral nasopharyngeal swab, and 1 tube of blood (10
ml) in case of ILI symptoms. This will be repeated 8 weeks later. The potential
risks are considered minimal. There are no benefits for the individual subjects
who participate in this trial. The results are possibly of benefit on a
population level in the future. The study population is the target of the
yearly influenza vaccination campaign.
postbus 1
3720 BA
NL
postbus 1
3720 BA
NL
Listed location countries
Age
Inclusion criteria
• >= 60 years of age
• Willing to present when ILI symptoms occur
• Signed Informed Consent
Exclusion criteria
none
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 | NL37392.094.11 |