Please find the approved entry criteria for use in the UK below. (Protocol versions 1.06 and 1.07.)

Entry criteria

This study will recruit previously-well individuals with critical illness due to primary infection with a specific pathogen, or following a quantifiable sterile injury consistent with the subsequent development of organ failure. Recruitment will be expanded or contracted subject to the availability of funds and local disease incidence, according to the groups described here.

Inclusion criteria

Patients will be recruited who:

Emerging Infections

Emerging infections are by their nature unpredictable and present a significant challenge to the international research community. In order to ensure research preparedness, in accordance with the principles laid out by the International Severe Acute and Emerging Infection Consortium (ISARIC)(Dunning et al. 2014), patients will be recruited to this study if they have confirmed or suspected infection with a novel pathogen, a new strain of an existing pathogen, or a re-emerging known pathogen, that causes life-threatening illness. This will include the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), highly pathogenic strains of influenza, Ebola virus disease and other epidemics of viral haemorrhagic fever.

Exclusion criteria

Patients who are functionally limited by any comorbid illness or have significant immunosuppression will be excluded from this study. Specifically, patients who have any of the conditions listed below will be excluded:

  1. demographic criteria:

    1. age  > 70
  2. chronic functionally-limiting comorbid illness, including:

    1. asthma

    2. chronic obstructive pulmonary disease (COPD)

    3. bronchiectasis

    4. heart failure

    5. alcoholic liver disease

    6. cirrhosis of the liver (any cause)

  3. primary immunosuppressive disease, including:

    1. acquired immunodeficiency syndrome (AIDS)

    2. severe combined immunodeficiency

  4. therapeutic immunosuppression, including:

    1. antineoplastic chemotherapy

    2. long-term ( > 7days) steroid treatment

  5. major trauma, including:

    1. perforated hollow viscus

    2. aortic rupture

    3. traumatic brain injury (haemorrhage/DAI/Contusion)

Dunning, Jake W., Laura Merson, Gernot G. U. Rohde, Zhancheng Gao, Malcolm G. Semple, Dat Tran, Anthony Gordon, et al. 2014. “Open Source Clinical Science for Emerging Infections.” The Lancet Infectious Diseases 14 (1): 8–9.