Plain English Summary
Background and study aims
Arboviruses are a group of viruses that can be transmitted to humans by insects and ticks. Arbovirus infections usually only cause mild disease, but some people they can be more serious and can lead to admission to hospital. The symptoms of an arbovirus infection can resemble other illnesses, and so very specific testing is needed for it to be diagnosed. The symptoms can also vary a lot between people, which makes diagnosis even more difficult. Little is known about how many people are affected by these viruses in Europe, or why some people develop more severe symptoms. The aim of this study is to find out how many people who are admitted to hospital with similar symptoms actually do have an arbovirus infection.
Who can participate?
Adults admitted to hospital with suspected arbovirus infection.
What does the study involve?
Participants have blood samples (and spinal fluid samples if available) collected when they are admitted to hospital, on day 7 (or when they are discharged from hospital if before 7 days), day 28, and on day 60. These samples are then tested in the laboratory for the presence of antibodies against arboviral infections. Participants also complete a number of questionnaires on day 28 and day 60 in order to assess their recovery and state of health.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part in this study. There is no risk in taking part other than some possible discomfort when the blood samples are collected.
Where is the study run from?
1. Infectious and Tropical Diseases Hospital (Romania)
2. Clinic for Infectious Diseases (Croatia)
3. Ippokrateio General Hospital of Athens (Greece)
4. University Hospital Centre "Mother Teresa" (Albania)
5. University Clinical Center of Kosovo (Kosovo)
6. Clinical Center of Serbia (Serbia)
When is the study starting and how long is it expected to run for?
May 2016 to December 2017
Who is funding the study?
European Commission (Belgium)
Who is the main contact?
Ms Emmanuelle Denis
Trial website
http://www.prepare-europe.eu/About-us/Workpackages/Workpackage-3
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Multi-centre EuRopean study of MAjor Infectious Disease Syndromes (MERMAIDS) – Observational Study of Arboviral Compatible Febrile Illness in Hospitalised Patients
Acronym
MERMAIDS-ARBO
Study hypothesis
The aim of this study is to estimate the proportion of adult hospital admissions with a febrile illness in South East Europe that are attributable to four arbovirus infections:
1. West Nile Virus (WNV)
2. Toscana virus (TOSV)
3. Tick borne encephalitis virus (TBEV)
4. Crimean Congo haemorrhagic fever virus (CCHFV)
Ethics approval
Oxford Tropical Research Ethics Committee (OxTREC), 12/08/2015, ref: 31-15
Study design
Multi-centre observational case series study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Arboviral compatible febrile illness
Intervention
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.
Intervention type
Phase
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/05/2016
Overall trial end date
31/12/2017
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1500
Participant 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
Recruitment start date
01/05/2016
Recruitment end date
31/10/2017
Locations
Countries of recruitment
Albania, Croatia, Greece, Kosovo, Romania, Serbia
Trial participating centre
Infectious and Tropical Diseases Hospital
Sos. Mihai Bravu nr. 281
Sector 3
Bucuresti
030303
Romania
Trial participating centre
Klinika za infektivne bolesti (Clinic for Infectious Diseases)
Mirogojska 8
Zagreb
10 000
Croatia
Trial participating centre
Ippokrateio General Hospital of Athens
Sofias 114
Athens
115 27
Greece
Trial participating centre
Qendra Spitalore Universitare “Nënë Tereza” Tirane (University Hospital Centre "Mother Teresa")
Rruga e Dibrës 372
Tirana
1000
Albania
Trial participating centre
University Clinical Center of Kosovo
Prishtina
10000
Kosovo
Trial participating centre
Clinical Center of Serbia
Pasterova 2
Belgrade
11000
Serbia
Sponsor information
Organisation
University of Oxford
Sponsor details
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
+44 1865 572221
ctrg@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
European Commission
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Belgium
Results and Publications
Publication and dissemination plan
The results will be reported in the annual reports for the sponsors, ethics commission and funders. The final results will be reported in a final report sent to all of the above. Results will also be published on the PREPARE website and in open-access, peer-reviewed publications and at scientific meetings and conferences.
Intention to publish date
30/06/2018
Participant level data
Stored in repository
Results - basic reporting
Publication summary