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Vaststellen van ziekteverwekkers van griepachtige verschijnselen bij ouderen.


- candidate number12213
- NTR NumberNTR3386
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2012
- Secondary IDs37392 / VAC-261; ABR / protocol ID
- Public TitleVaststellen van ziekteverwekkers van griepachtige verschijnselen bij ouderen.
- Scientific TitleIdentification of pathogens responsible for influenza-like illness in elderly in The Netherlands.
- ACRONYMGRIEP-1, GRIEP-2
- hypothesisInfluenza-like-illness (ILI) is not only caused by an influenza virus infection, but also by other pathogens, both viral and bacterial. In this study nose and throat swab samples will be taken during ILI episodes to identify pathogens causing ILI in the elderly population.
- Healt Condition(s) or Problem(s) studiedInfectious diseases, Influenza, Viral, Bacterial, Carriage
- Inclusion criteria1. ≥ 60 years of age;
2. Willing to present when influenza-like-illness (ILI) symptoms occur;
3. Signed Informed Consent.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2011
- planned closingdate30-jun-2013
- Target number of participants2500
- InterventionsN/A
- Primary outcomePresence of influenza A and B virus in nasal swab during ILI episodes.
- Secondary outcome1. Subtyping of influenza viruses in case of influenza infection;
2. Antibody levels to influenza virus;
3. 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;
4. Presence of S. pneumoniae in saliva;
5. Antibody levels towards viral and bacterial pathogens present in the swabs as identified by PCR or bacterial culture;
6. A SF-36 (short-form health survey) questionnaire at baseline.
- TimepointsTimepoint 1: Within 72 hours after onset of fever and at least 1 other ILI symptom;
Timepoint 2: 8 weeks after timepoint 1;
Extra timepoint: Any timepoint in subjects who do not (yet) have ILI symptoms during the influenza season.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.A.J. Boxtel, van
- CONTACT for SCIENTIFIC QUERIESPhD J. Beek, van
- Sponsor/Initiator Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD6-apr-2012 - 15-apr-2012


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