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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03451656
Other study ID # 2016-01735; me15Egli2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 27, 2016
Est. completion date April 30, 2017

Study information

Verified date March 2023
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4000
Est. completion date April 30, 2017
Est. primary completion date April 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Outcome

Type Measure Description Time frame Safety issue
Primary Similarity of Influenza viruses 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. at baseline
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