Condition category
Infections and Infestations
Date applied
11/08/2015
Date assigned
21/01/2016
Last edited
21/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Ms Emmanuelle Denis

ORCID ID

Contact details

NDM Research Building
Centre for Tropical Medicine
Roosevelt Drive
Oxford
OX3 7FZ
United Kingdom

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

http://www.admin.ox.ac.uk/researchsupport/ctrg/

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

Publication citations

Additional files

Editorial Notes