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

Multi-centre EuRopean study of MAjor Infectious Disease Syndromes (MERMAIDS) – Observational Study of Arboviral Compatible Febrile Illness in Hospitalised Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN74074706
Enrollment
1500
Registered
2016-01-21
Start date
2016-05-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arboviral compatible febrile illness Infections and Infestations Arboviral compatible febrile illness

Interventions

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 m

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Albania, Croatia, Greece, Kosovo, Romania, Serbia

Contacts

Public ContactJames Lee
james.lee@ndm.ox.ac.uk+44 (0) 1865 612979

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026