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van CCT (UK)

van CCT (UK)

Severe acute respiratory infections, the missing link in the surveillance pyramid

- candidate number25188
- NTR NumberNTR6079
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-aug-2016
- Secondary IDs15-483/C METC UMC Utrecht
- Public TitleSevere acute respiratory infections, the missing link in the surveillance pyramid
- Scientific TitleSevere acute respiratory infections, the missing link in the surveillance pyramid
- ACRONYMSARI surveillance
- hypothesisThe primary objective is to set up a pilot sentinel syndromic surveillance system for patients with a severe acute respiratory infection (SARI) requiring hospital admission
- Healt Condition(s) or Problem(s) studiedSevere acute respiratory infections, Surveillance, Hospitalization
- Inclusion criteriaA SARI patient will be defined as a hospitalised person with:

•at least one systemic symptom or sign: fever or feverishness, malaise, headache or myalgia or deterioration of general condition (asthenia or loss of weight or anorexia or confusion or dizziness)
v and

•at least one respiratory symptom or sign (cough, sore throat or shortness of breath) at admission or within 48 hours after admission.
- Exclusion criteriaThe symptoms of onset should not have started (or clearly worsened, if chronic) more than 7 days at admission
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 19-okt-2015
- planned closingdate1-apr-2019
- Target number of participants0
- InterventionsThis is not an intervention study
- Primary outcomeThe development and establishment of a sustainable SARI surveillance system that, when this is proven feasible, will be extended to other hospitals from the year 2019 onward. The end result is an integrated respiratory surveillance system covering the full spectrum of respiratory infections, which provides input for (inter)national public administrations and is used for policy decisions.
The planned products are:
•Protocol for the implementation of a potential nationwide sustainable continuous SARI surveillance;
•Weekly publication of the results of fully integrated respiratory surveillance system on RIVM website.
- Secondary outcome•Seasonal influenza vaccine effectiveness against influenza laboratory confirmed SARI hospitalisation among patient 65 years of age and above.
•Data used for pooling with 22 hospitals in other European countries to obtain robust data on influenza vaccine effectiveness against severe outcomes.
•Amount of SARI patients attributable to influenza and/or other causative respiratory pathogens per influenza season.
•The disease burden of influenza on different health care levels.
- TimepointsWithin the whole study period, important timepoints are:
•influenza season 2015-2016
•influenza season 2016-2017
•influenza season 2017-2018
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator National Institute for Public Health and the Environment (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Education, Culture and Science
- PublicationsMarbus SD et al. Ernstige acute luchtweginfecties: de ontbrekende bouwsteen in de surveillance piramide. Nederlands Tijdschrift voor Medische Microbiologie 2016; 1: 52-56
- Brief summarySurveillance of respiratory infections in primary care in the Netherlands was established more than 40 years ago. The registration of influenza-like illness by general practitioners, complemented by virological analysis of nasal/ throat swabs, represent the current base of the surveillance pyramid of respiratory infections in the Netherlands. The missing link between primary care and crude mortality monitoring is the surveillance of patients with severe acute respiratory infections (SARI) requiring hospital admission. A sustained SARI surveillance system detects outbreaks in time, place, causative pathogen and person in order to implement and evaluate health care interventions. Several other countries have implemented an operative SARI surveillance system as advised by the World Health Organization (WHO). From October 2015 onwards, a pilot study started at the Jeroen Bosch Hospital and Leiden University Medical Center with the main objective to set up a sentinel surveillance system for SARI patients in the Netherlands. However, adding laboratory diagnostic results is crucially important and should result in a sustained integrated respiratory surveillance system in the future.
- Main changes (audit trail)
- RECORD18-aug-2016 - 11-nov-2016

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