Condition category
Respiratory
Date applied
21/07/2015
Date assigned
31/07/2015
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
An acute respiratory infection (ARI) is a serious infection of the sinuses, throat, airways or lungs that prevents normal breathing function. Pathogens (viruses/bacteria) causing ARI are among the most likely candidates to cause the next pandemic. We need to better understand why some people become much more ill than others when they have an ARI. The elderly, people with chronic lung, heart or metabolic disease or immunocompromised (weakened immune system) patients are known to be at risk of developing severe disease. However, some respiratory infections can also cause severe disease in younger previously healthy individuals due to a combination of the virus itself and the individual’s immune responses. It is likely that individual risk factors affect the body’s response to ARI in different ways and this in turn can influence the severity of disease. Within broad risk groups it is currently not possible to predict which individuals are at increased risk of becoming severely ill. Consequently, there are no opportunities to tailor treatments. In people who become moderately or severely ill, there is an assumption that the body’s underlying response to disease is the same and hence that everyone will benefit equally from the same treatments. Increased insight into how different individuals respond to respiratory pathogens can allow us to better anticipate the severity of disease for a particular patient. This in turn will enable us to make strategies for individualized treatment options to reduce disease severity, risk of complications and hospitalisations.

Who can participate?
People aged over 18 attending primary and secondary care with mild to severe ARI.

What does the study involve?
Blood and respiratory (lung) samples will be collected from patients. We will analyse the samples to observe individual gene activity and we will compare samples from people with different risk factors for more severe disease. This will provide a detailed insight into how the body responds to infection and provide opportunities to understand the specific contributions of different risk factors.

What are the possible benefits and risks of participating?
There will be no direct benefit to participants. The study includes serial biological sampling which is in addition to that required for medical management. The results of the tests done on these samples may not contribute to improving the participant’s health. The results of this study will not be available in time to contribute to the patient’s care for this episode of ARI. This is an observational study and thus it is a very low-risk study. Participants will have three blood draws, which can be associated with pain at the draw site and rarely with infection. Respiratory swabs may be uncomfortable to obtain. Discomfort and risk will be minimized by using experienced clinical staff at each site. Participation in this research study poses a minimal risk of inconvenience through attendance of two follow-up visits. The risks are even lower for secondary care participants as the research sampling will be timed to coincide with routine clinical sampling which normally occurs daily in acutely unwell patients in hospital.

Where is the study run from?
Oxfordshire Primary Care Trust (UK).

When is the study starting and how long is it expected to run for?
From October 2015 to May 2018.

Who is funding the study?
European Commission.

Who is the main contact?
Emmanuelle Denis

Trial website

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 Acute Respiratory Infections in Primary and Secondary Care

Acronym

MERMAIDS-ARI

Study hypothesis

In this study we will recruit people attending primary and secondary care in order to capture people with mild to severe acute respiratory infections (ARI). We will analyse samples to observe individual gene activity and we will compare samples from people with different risk factors for more severe disease. This will provide a detailed insight into how the body responds to infection and provide opportunities to understand the specific contributions of different risk factors.

Ethics approval

NRES Committee West Midlands - The Black Country, 27/08/2015, ref: 15/WM/0254

Study design

Multi-centre observational study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Acute respiratory infections

Intervention

This is an observational study. Blood and respiratory samples will be collected at baseline, day 2, date of hospital discharge (if applicable) and day 28. Samples will be analysed to determine aetiology of respiratory infection and to identify host and pathogen related determinants of severity of infection.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Differentially expressed host genes (nominal ≥ 2-fold difference in expression levels) as assessed by RNA transcriptome microarray in hospitalised and primary care managed cases of ARI, stratified by pathogen* and comorbidity**.
*Influenza virus, Human Rhinovirus, Respiratory Syncytial Virus, Streptococcus pneumoniae
**No comorbidity, chronic pulmonary disease, chronic cardiovascular disease, chronic metabolic disease (diabetes)

Secondary outcome measures

In both groups:
1. Prevalence of detection of putative pathogens in respiratory tract samples
2. Proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.
3. 28-day mortality

Additional in group 1 (primary care):
1. Proportion of cases requiring hospitalisation

Additional in group 2 (hospitalised patients):
1. Severity of illness at enrolment as assessed by Pneumonia Severity Index (PSI) and CURB-65
2. Proportion of cases requiring during admission: supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support
3. Duration of invasive mechanical ventilation and extra-corporeal life support, if applicable
4. Proportion of cases requiring Intensive Care Unit (ICU)/High Care Unit (HCU) admission
5. Hospital and ICU/HCU length of stay
6. In-hospital mortality

Overall trial start date

01/10/2015

Overall trial end date

31/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Group 1 – primary care patients:
1. Age ≥ 18 years
2. Patient is self-attending to primary care (i.e. ambulatory)
3. Clinical suspicion of a new episode of acute respiratory tract infection
4. Onset of the following symptoms within the last 7 days:
4.1. Sudden onset of self-reported fever OR tympanic temperature of ≥ 38°C at presentation
AND
4.2. At least one respiratory symptom (cough, sore throat, runny or congested nose)
AND
4.3. At least one systemic symptom (headache, muscle ache, sweats or chills or tiredness)

Group 2 – hospitalised patients:
1. Age ≥ 18 years
2. Clinical suspicion of a new episode of acute respiratory tract infection
3. Patient is admitted to hospital
4. Primary reason for hospital admission is clinical suspicion of a new episode of ARI
5. Onset of the following symptoms within the last 7 days:
5.1. Sudden onset of self-reported fever OR tympanic temperature of ≥ 38°C at presentation
AND
5.2. At least one respiratory symptom (cough, sore throat, runny or congested nose)
AND
5.3. At least one systemic symptom (headache, muscle ache, sweats or chills or tiredness)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

Group 1 – primary care patients:
1. Patient lacks capacity to provide informed consent
2. No informed consent is provided by patient
3. The attending primary care physician decided to send patient to the hospital for assessment and possible hospital admission
4. Patient is enrolled in an interventional clinical study

Group 2 – hospitalised patients:
1. Patient lacks capacity to provide informed consent
2. No informed consent is provided by patient
3. Patient has been transferred from another hospital
4. Patient is enrolled in an interventional clinical study

Recruitment start date

01/10/2015

Recruitment end date

30/04/2018

Locations

Countries of recruitment

Croatia, Germany, Ireland, Netherlands, Poland, Romania, Spain, United Kingdom

Trial participating centre

Oxfordshire Primary Care Trust
OX4 2LH
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom

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

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.