Last Updated: 12/12/2024
ISARIC/ALERRT Clinical Characterisation Protocol (CCP) observational study
Objectives
Overall goal
To foster global collaborative patient-oriented research between and during epidemics.
Objectives
To generate and disseminate clinical research evidence whenever and wherever infectious disease outbreaks occur or are a threat. In potential participants meeting the entry criteria, our primary objectives for each individual pathogen are to:
- Describe the clinical features of the illness or syndrome
- Describe, where appropriate, the response to treatment, including supportive care and novel therapeutics.
- Observe, where appropriate and feasible, pathogen replication, excretion and evolution, within the host, and identify determinants of severity and transmission using high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples.
- Characterize, where appropriate and feasible, the host responses to infection and therapy over time, including innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood.
- Identify host genetic variants associated with disease progression or severity
- Understand transmissibility and the probabilities of different clinical outcomes following exposure and infection
Secondary objectives are to collect evidence in order to:
- Facilitate effective triage and clinical management of patients with infections relevant to this protocol
- Determine infectivity and appropriate infection control measures of the various pathogens
- Develop clinical guidance documents and offer clinical recommendations to policy makers on the basis of evidence obtained
- Understand the broader epidemiology of an emerging infection through studying potential contacts and asymptomatic individuals
Africa Centres for Disease Control and Prevention (Africa CDC), Ethiopia
Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking.
In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility.This is a standardized protocol for the rapid, coordinated clinical investigation of severe or potentially severe acute infections by pathogens of public health interest. Patients with acute illness suspected to be caused by emerging and unknown pathogens will be enrolled. This protocol has been designed to enable data and biological samples to be prospectively collected and shared rapidly in a globally-harmonised sampling schedule. Multiple independent studies can be easily aggregated, tabulated and analysed across many different settings globally. The protocol is the product of many years of discussion among international investigators from a wide range of scientific and medical disciplines.
Recruitment under this protocol has been initiated in response to Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV) in 2012-2013, Influenza H7N9 in 2013, viral haemorrhagic fever (Ebolavirus) in 2014, Monkeypox & MERS-coronavirus in 2018, Tick-borne encephalitis virus (TBEV) in 2019 and nCoV-2019 in 2020.
Observational
This is a descriptive study of a syndrome, which may be caused by a number of different known or poorly understood pathogens. Therefore, the sample size is not prospectively determined. Recruitment of participants will depend on the emergence and spread of the various pathogens and the resources available to the recruitment centres. The sample size will vary for each location but should be as large as feasible and preferably without limit in order to capture as much clinical data as possible early in the outbreak. This protocol will be opened at sites with the capacity and capability to recruit to any tier of study intensity. The study has no set end date.
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