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Prospective System Analysis of the Seasonal Influenza Virus Transmissions and Evolution in the City of Basel Basel (me15Egli2_CTU)

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ClinicalTrials.gov Identifier: NCT03451656
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The 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. Investigators aim to quantitatively characterize the viral transmission using novel molecular-epidemiological tools based on whole genome sequencing.

Condition or disease
Influenza

Detailed Description:
Samples will be collected such as whole blood, serum and DNA, nasopharyngeal swamps to diagnose influenza by polymerase chain reaction (PCR) 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.

Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective System Analysis of Seasonal Influenza - Virus Transmission and Evolution in Basle Town
Actual Study Start Date : December 27, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot




Primary Outcome Measures :
  1. Similarity of Influenza viruses [ Time Frame: at baseline ]
    Genomic sequencing of single virus of individual patients and comparison of genetic similarity of viruses. Grouping of patients with a same virus - this includes a range of single nucleotide polymorphisms of 0-150 differences inbetween the virus population.


Biospecimen Retention:   Samples With DNA
whole blood, serum and DNA, nasopharyngeal swamps


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Probability Sample
Study Population
Paediatric or adult patients fulfilling the WHO-definition of an influenza-like illness and living at Basel.
Criteria

Inclusion Criteria:

  • Each pediatric or adult patient, which fulfill the World 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.

Exclusion Criteria:

- Case definition for influenza like illness is not fulfilled


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): NCT03451656


Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Adrian Egli, PD MD Clinical Microbiology; University Hospital Basel

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03451656     History of Changes
Other Study ID Numbers: Influenza Transmission Basle
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases