Multi-centre European study of major infectious disease syndromes - Arboviral compatible febrile illness

• Register: ISRCTN
• Last refreshed on: 14 January 2019
• Main ID: ISRCTN74074706
• Date of registration: 21/01/2016
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: Multi-centre European study of major infectious disease syndromes - Arboviral compatible febrile illness
• Scientific title: Multi-centre EuRopean study of MAjor Infectious Disease Syndromes (MERMAIDS) – Observational Study of Arboviral Compatible Febrile Illness in Hospitalised Patients
• Date of first enrolment: 01/05/2016
• Target sample size: 1500
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN74074706
• Study type: Observational
• Study design: Multi-centre observational case series study (Other)

Countries of recruitment

Albania, Croatia, Greece, Kosovo, Romania, Serbia

Contacts

• Name: James Lee

• Name: James Lee

Key inclusion & exclusion criteria

Inclusion criteria:
1. Adults (= 18 years old) admitted to hospital from 1st May – 31st October inclusive with recent onset (<21 days) of symptoms of suspected Encephalitis or Meningitis .

OR

2. Rapid onset of temp.= 38°C of unknown etiology (<21 days) AND at least ONE of the signs or symptoms below:
2.1. A neurological symptom (such as: neck stiffness, photophobia, partial paralysis, polyradiculitis, periorbital pain, confusion, altered mental state)
2.2. Severe headache
2.3. Myalgia
2.4. Backache
2.5. Arthralgia
2.6. Maculopapular rash
2.7. Haemorrhagic symptom
2.8. Thrombocytopenia (<150 000 cells per microliter of blood)

Exclusion criteria:
1. Patients with non-infectious central nervous system (CNS) disorders due to hypoxic, vascular, toxic or metabolic causes
2. Patients where the symptoms are due to another confirmed cause, such as bacterial infection, malaria, malignancy, immune disorders, trauma
3. Patients with a focal source of infection identified, such as pneumonia, viral respiratory tract infection, acute infectious diarrhea, urinary tract infection (positive urine cultures), or skin or soft-tissue infection
4. Patients where the symptoms are caused by recurrence of a pre-existing condition


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Arboviral compatible febrile illness
Infections and Infestations
Arboviral compatible febrile illness

Intervention(s)

Blood and, if available, spinal fluid samples will be collected at baseline, day 7 (or date of hospital discharge), day 28 and day 60. Samples will be analysed to identify causative pathogens and to measure antibody levels.

Primary Outcome(s)

Proportion of adults hospitalised with a clinically compatible illness who have laboratory confirmed or probable TBEV, WNV, TOSV or CCHFV infection is determined at day 60.

Secondary Outcome(s)

1. Proportion of patients treated with antivirals, antibiotics and/or steroids
2. Daily clinical observations (vital signs, neurological and haemorrhagic symptoms) during admission
3. Level of consciousness determined according to the Glasgow Coma Scale in Adults at baseline
4. Proportion of patients receiving intensive care treatment and duration
5. Antibody levels are measured from blood samples at baseline, 7, 28 and 60 days
6. Neurological recovery and health outcomes are measured using the modified Rankin scale, Liverpool outcome scores for adults and EQ-5D-5L assessment at discharge and follow up (day 28 and 60)
7. Mortality rate is determined at day 60

Secondary ID(s)

N/A

Source(s) of Monetary Support

European Commission

Ethics review

Status:
Approval date:
Contact:

Oxford Tropical Research Ethics Committee (OxTREC), 12/08/2015, ref: 31-15

Results

• Results available: Yes
• Date Completed: 05/01/2020