Clinical characterisation protocol for severe emerging infectio

Not Applicable

• Conditions: Emerging infections; Infections and Infestations

• Registration Number: ISRCTN66726260
• Lead Sponsor: niversity of Oxford

Brief Summary

2020 Protocol article in https://www.bmj.com/content/369/bmj.m1985 protocol and results (added 28/05/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32960186/ results for children and young people (added 28/08/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32907855/ results (added 11/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34000238/ in-hospital mortality results (added 18/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34107928/ hospital bed pathway results (added 11/06/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35337642/ Implementation of corticosteroids (added 28/03/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36719907/ Outcome of COVID-19 in hospitalised immunocompromised patients (added 02/02/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38621404/ in-hospital mortality in patients with and without cancer (added 16/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-21
• Last Update Posted: 29 April 2024
• Study Completion: 2027-07-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients (children and adults) with confirmed infection with a pathogen relevant to the study objectives
2. Inclusion criteria for SARI patients:
2.1. Acute respiratory illness patients of all ages with a history of fever or measured fever of >38°C and at least one respiratory symptom
2.2. High suspicion or confirmed infection with a respiratory pathogen relevant to the objectives of this protocol
2.3. Admitted to a healthcare facility
3. Inclusion criteria for VHF patients:
3.1. Sudden onset high fever and known contact with a person with suspected or confirmed VHF
3.2. Sudden onset of fever with at least three of the following symptoms: headache; anorexia; lethargy; aching muscles or joints; breathing difficulties; vomiting; diarrhoea; stomach pain; dysphagia; hiccups
3.3. High suspicion or confirmed infection with a VHF pathogen relevant to the objectives of this protocol
3.4. Admitted to a healthcare facility
4. Inclusion criteria for patients with CNS infection
4.1. Fever >=38C or history of fever within 30 days in patients of all ages with one of:
4.1.1. Altered consciousness (including reduced conscious level, confusion, or a change in personality or behaviour)
4.1.2. New onset of seizures (excluding simple febrile seizures)
4.1.3. New onset focal neurological deficit
4.2. Electroencephalographic (EEG), neuroimaging or cerebrospinal fluid examination findings indicative of central nervous system infection
4.3. High likelihood of infection with a neuroinvasive pathogen of public health interest
4.4. Admitted to a healthcare facility
OR
4.5. Confirmed infection with a neuroinvasive pathogen of public health interest and admitted to a healthcare facility
5. Inclusion criteria for patients with infection by pathogens of public health interest:
This study will enrol eligible patients with suspected or confirmed infection with a pathogen of public health interest. These pathogens will be listed by the investigators taking into consideration position statements issued by World Health Organisation, Public Health England and other authorities.

Exclusion Criteria

Refusal to participate

Study & Design

• Study Type: Observational
• Study Design: Not specified