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Prospective Analysis of Seasonal Influenza - Viral Transmission and Evolution in the City of Basel, Switzerland

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ClinicalTrials.gov Identifier: NCT03010007
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Swiss Federal Institute of Technology
University Children's Hospital Basel
University of Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:

Influenza associated illness has a global annual impact with high morbidity and mortality. Transmission mechanisms and rates are under-investigated and overall poorly understood.

This project aims to use epidemiological tools to understand the transmission and evolution of influenza viruses at an individual and population level within a small-scale city (Basel) through a combination of experimental, clinical and mathematical advances. The investigators aim to quantitatively characterize the viral transmission using novel molecular-epidemiological tools based on whole genome sequencing.


Condition or disease
Influenza

Detailed Description:

In this prospective observational study, paediatric and adult outpatients presenting with influenza-like illness will be enrolled at the emergency departments of the University Hospital Basel (USB), the paediatric University Hospital of both Basel (UKBB), or a network of family doctors (associated with Center of Primary Health Care).

The Clinical Trial Unit at the University Hospital Basel will coordinated the recruitment process, collect data and sample all patients during the influenza season 2016/17. Samples will be collected such as whole blood, serum and DNA, nasopharyngeal swamps to diagnose influenza by polymerase chain reaction (PCR) assay and to determine colonization rates with Staphylococcus aureus and Streptococcus pneumonia. All samples except the first naso-pharyngeal swab for influenza diagnostics will be stored in a biobank and analysed in batches. Each influenza virus isolate will be sequenced using a "whole genome sequencing" approach. The viral transmission and evolution will be analysed using whole genome data for a detailed molecular and phylogenetic tree analysis, respectively. The epidemiological and geographical data will be incorporated into the phylogenetic model.

Specific aims are:

(i) to determine the impact of the most important epidemiological parameters, first focusing on the age profile, followed by children per house hold, and population density, on influenza transmission at an individual and population level, drawing on an analysis of baseline humoral immunity and whole genome sequencing data, (ii) to understand the viral evolution during seasonal epidemics, (iii) to develop dynamic mathematical models that are able to predict viral transmission and evolution based on the retrospective results from (i) and (ii) and to validate this model in future influenza seasons.

To realize the interdisciplinary approach, the investigators will rely on the expertise in mathematical modelling of viral epidemiology and evolution and established geographical expertise, next generation sequencing, clinical epidemiology, and immunologic diagnostic techniques.

Study Design
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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Prospective Analysis of Seasonal Influenza - Viral Transmission and Evolution in the City of Basel, Switzerland [Prospektive Systemanalyse Der Saisonalen Influenza - Virustransmission Und Evolution in Der Stadt Basel] in German
Study Start Date : January 2017
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Investigation of the phylogenetic relation of viral isolates from participating patients using whole-genome sequencing and bioinformatics [ Time Frame: Baseline ]
    The primary microbiological endpoint is the connection of two viral isolates via comparison and phylogenetic analysis by using the genetic information


Biospecimen Retention:   Samples With DNA
blood (serum) and nasopharyngeal swabs

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Paediatric or adult patients fulfilling the World Health Organization (WHO) definition of an influenza-like illness. A total number of 1000 influenza PCR-confirmed cases should be included.
Criteria

Inclusion Criteria:

  • Each pediatric or adult patient, which fulfill the Worl Health Organization (WHO) definition of Influenza like illness.
  • The case definition includes an acute respiratory infection with coughing, fever ≥38°C, and start of symptoms within the last 10 days.
  • Presentation of the patient with influenza-like illness on the emergency ward of the University Hospital Basel or the University Children Hospital of both Basel or a collaborating private practise.
  • Patient has to live in the city of Basel.

Exclusion Criteria:

  • Patients who are not living in the City of Basel.
  • Case definition for influenza like illness is not fulfilled.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010007


Locations
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Switzerland
Federal Institute of Technology Zurich
Basel, Switzerland, 4031
University Children's Hospital
Basel, Switzerland, 4031
University Hospital Basel
Basel, Switzerland, 4031
Universitätres Zentrum für Hausarztmedizin beider Basel, University of Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss Federal Institute of Technology
University Children's Hospital Basel
University of Basel
Investigators
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Principal Investigator: Adrian Egli, PD Dr. FAMH Clinical Microbiology, University Hospital Basel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03010007    
Other Study ID Numbers: Influenza in Basel 2016/2017
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Basel, Switzerland:
Influenza
High-Throughput Nucleotide Sequencing
Viral Transmission
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases