BioResource in Adult Infectious Disease

Summary

BioAID 2024-2029 is a an adaptive multi‑centre research tissue bank (RTB) to enable observational studies in adult infectious diseases. We combine host and pathogen samples with routinely collected health records from adult hospital patients with suspected or proven infectious disease, with capacity to recall participants for secondary studies. We aim to provide the foundation for discovery and validation of novel biomarkers and multivariable models for diagnostic, prognostic and therapeutic stratification of adult patients with infectious diseases, and for identification of novel therapeutic targets.

Study design

BioAID incorporates multiple recruitment streams that are implemented for designated periods of time specified by the executive committee, subject to written applications to the RTB that specify the rationale, target population, inclusion/exclusion criteria and target sample size.  We use a deferred consent approach. In each recruitment stream, routine clinical sampling will be accompanied by collection of index research samples among adult participants who fulfil the stream-specific inclusion criteria.

Active recruitment streams

Treatment stratification for influenza

This stream focuses on targeted recruitment of patients with proven influenza infection, particularly to enable co-recruitment of adult participants from the intervention (neuraminidase inhibitor) and control (placebo) arms of the multicentre REMAP-CAP and RECOVERY trials for influenza at participating BioAID sites (N=120). The primary objective is to test the hypothesis that the treatment effect of oseltamivir on influenza viral load is limited to individuals with high baseline MX-1 transcript and protein levels.

Stratification of acute respiratory infection syndromes in ED

This stream focuses on targeted recruitment of patients with suspected respiratory tract infections, using rapid respiratory virus PCR testing in the ED as a surrogate for suspicion of acute respiratory infection (N=1000). The objectives are to enable Novel approaches to patient stratification are required to support management decisions including admission to hospital, supportive care, choice of antimicrobial treatment and potentially immunomodulatory treatments. Immunophenotyping of this cohort also offers the opportunity to evaluate immunological correlates of specific infections.

Suspected infection among emergency admissions

This stream focuses on recruitment of patients with suspected infection who present to hospital as an emergency admission, using blood culture sampling as indication for suspected infection (N=1000). This recruitment stream is designed to provide blood RNA and serum samples for diagnostic/prognostic biomarker evaluation across the spectrum of UK hospital infectious disease presentations.

iSpy-LIFE-understanding iGAS

This recruitment stream focuses on targeted recruitment of patients with confirmed or strongly-suspected group A streptococcal infection (GAS) that is severe enough to warrant presentation to hospital. Although most of these will be invasive (i)GAS, the stream will include patients with severe GAS mucosal infections, GAS quinsy and GAS cellulitis that might not typically be notified as iGAS. The objectives are to (1) to facilitate stratification of patients by final outcome, by measurement of biomarkers of inflammation and immune response at presentation and at one follow up point and (2) to facilitate stratification of patients who are recruited to a planned interventional iGAS study (STRAP) at participating BioAID sites (N=120).