Emerging infections Infections and Infestations
Conditions
Interventions
Patients with confirmed infection with pathogen of public interest, or an appropriate consultee, will be approached by staff who will explain the details of the study to the patient or consultee and a
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At baseline, day three, day nine and > 28 days after hospital discharge: 1. Changes in pathogen during infection and during spread between individuals and development of resistance measured using: 1.1. Respiratory samples: 1.1.1. Nasal SAM strip 1.1.2. Throat swab in virus transport medium 1.1.3. Endotracheal aspirate if intubated, 1.1.4. Where resources permit, in infants/children who cannot take SAM strip, nasopharyngeal aspirate OR flocked nose swab in virus transport medium 1.2. Urine (up to 10ml) 1.3. Stool (up to 10ml) or rectal swab 1.4. Samples from infected sites/sores 1.5. Any residual from samples taken for clinical care 2. Non-invasive determination of humoral immune response measured using oral fluid (Crevicular fluid) 3. Mediators/biomarkers and serology measured using blood sample in serum (clotted) tube 4. Mediators/ metabolites/ biomarkers and RNA/DNA from pathogens measured using blood sample in EDTA tube 5. Microarray/RNA sequencing pathogen & host transcriptome measured using blood sample in blood RNA tube TempusTM (or PAXgene®) 6. For CNS infections only: additional cerebrospinal fluid sample during clinical lumbar puncture to measure Mediators/ metabolites/ biomarkers and RNA/DNA from pathogens and to perform serological testing for pathogen-specific antibodies | — |
Countries
England, United Kingdom
Contacts
Public ContactHayley Hardwick
Outcome results
None listed