Multi-centre European study of major infectious disease syndromes - Arboviral compatible febrile illness
| ISRCTN | ISRCTN74074706 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74074706 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/08/2015
- Registration date
- 21/01/2016
- Last edited
- 05/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Public
Wellcome Trust Centre for Human Genetics
University of Oxford
Roosevelt Drive
Oxford
OX3 7BN
United Kingdom
| Phone | +44 (0) 1865 612979 |
|---|---|
| james.lee@ndm.ox.ac.uk |
Scientific
Wellcome Trust Centre for Human Genetics
University of Oxford
Roosevelt Drive
Oxford
OX3 7BN
United Kingdom
| Phone | +44 (0) 1865 612979 |
|---|---|
| james.lee@ndm.ox.ac.uk |
Study information
| Study design | Multi-centre observational case series study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Multi-centre EuRopean study of MAjor Infectious Disease Syndromes (MERMAIDS) – Observational Study of Arboviral Compatible Febrile Illness in Hospitalised Patients |
| Study acronym | MERMAIDS-ARBO |
| Study objectives | 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(s) | Oxford Tropical Research Ethics Committee (OxTREC), 12/08/2015, ref: 31-15 |
| Health condition(s) or problem(s) studied | 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 | Other |
| Primary outcome measure | 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 study start date | 01/05/2016 |
| Completion date | 05/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1500 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/05/2016 |
| Date of final enrolment | 31/10/2019 |
Locations
Countries of recruitment
- Albania
- Croatia
- Greece
- Kosovo
- Romania
- Serbia
Study participating centres
Sector 3
Bucuresti
030303
Romania
Zagreb
10 000
Croatia
Athens
115 27
Greece
Tirana
1000
Albania
10000
Kosovo
Belgrade
11000
Serbia
Sponsor information
University/education
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 1865 572221 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.admin.ox.ac.uk/researchsupport/ctrg/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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. |
| IPD sharing plan |
Editorial Notes
05/12/2018: The following changes have been made:
1. Emmanuelle Denis has been removed as the public contact and James Lee added as the public and scientific contact.
2. The recruitment end date has been changed from 31/10/2017 to 31/10/2019.
3. The overall trial end date has been changed from 31/12/2017 to 05/01/2020.
4. The intention to publish date has been changed from 30/06/2018 to 01/06/2020.
5. The sponsor address has been changed.
