Multi-centre European study of major infectious disease syndromes - Arboviral compatible febrile illness
| ISRCTN | ISRCTN74074706 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74074706 |
| Protocol serial number | N/A |
| Sponsor | University of Oxford |
| Funder | European Commission |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre observational case series study |
| Secondary study design | Case series |
| 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(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. |
| Key secondary outcome measure(s) |
1. Proportion of patients treated with antivirals, antibiotics and/or steroids |
| Completion date | 05/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
