Next Generation Sequencing in Suspected Infection: SePSI V1.0
Research type
Research Study
Full title
The Use of Unbiased Next Generation Sequencing for Pathogen Detection in Adults Hospitalised with Acute Undifferentiated Febrile Illness and Suspected Infection: An Observational Pilot Study (SePSI)
IRAS ID
174619
Contact name
Tristan Clark
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study aims to evaluate whether unbiased next generation sequencing (NGS) using the Illumina MiSeq has diagnostic utility in the investigation of patients presenting with acute undifferentiated febrile illness (AUFI) where conventional diagnostic methods have failed to identify the causative pathogen.
This prospective, controlled, cohort study will act as a pilot study to inform a larger multi-centre prospective randomised study. Consented adult patients presenting to Southampton General Hospital will be enrolled. Serum, whole blood, nasopharyngeal swabs, urine and stool if diarrhoea is present will be taken and stored for retrospective analysis. If obtained in routine clinical care, cerebral spinal fluid (CSF) and tissue will also be analysed. These samples will be retrospectively evaluated with the Illumina MiSeq next generation sequencer.
Detailed clinical, phenotypic and outcome data will be collected prospectively on enrolment and retrospectively at follow up to enrich data interpretation. Where conventional diagnostic tools yield a clinically credible diagnosis these samples will be used as a control to check internal validity of the Illumina MiSeq results. Fifty healthy volunteers will be recruited to evaluate the microbiome/virome in assymptommatic individuals.
The study will take place over 24 months and aims to recruit 150 participants. One hundred participants with AUFI will be recruited assuming 50% will achieve a diagnosis by standard investigation and the remainder will remain undiagnosed. Fifty healthy volunteers will additionally be recruited.
The potential clinical impact of NGS will be assessed by determining the number of additional diagnoses which are made using unbiased next generation sequencing. This data will be compared to that obtained from the group achieving a diagnosis by standard investigation and the healthy control group. Analysis will take place of the potential clinical impact of NGS on the diagnosis of AUFI and subsequent outcomes had NGS data been available in a clinically useful time frame.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0429
Date of REC Opinion
16 Oct 2015
REC opinion
Further Information Favourable Opinion