PREDICT-ILI
Research type
Research Study
Full title
Predicting severity and disease progression in influenza-like illness
IRAS ID
286372
Contact name
Christopher Chiu
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza (‘flu’) is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective.
This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help us to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection.
We aim to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28.
The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.
Summary of study results:
The study aimed to recruit 100 participants. This target was not met, with a total of 8 participants enrolled before the study completed. Due to the COVID-19 pandemic, the recruitment of volunteers was challenging.
A total of 745 patients who presented to A&E at the recruiting sites were pre-screened against the inclusion/exclusion criteria.
The primary reason for pre-screened participants not enrolling into the study was initially due to the onset of symptoms of an acute respiratory illness persisting longer than 7 days before admission. A Substantial Amendment (SA1) was granted to change the inclusion criteria from eligible if onset of symptoms started within 7 days of admission, to extend to 12 days.
• Prior to SA1 60% of pre-screened patients had symptoms for longer than 7 days on further investigation.
• Following SA1 23.8% of pre-screened patients had symptoms for longer than 12 days on further investigation.
Of the patients who did meet the initial pre-screening criteria, based on their A&E attendance record;
• 5.4% declined to participate
• 24.7% lacked capacity and were unable to consent. The study team observed that this was due to either confusion or intubation.Primary Objective: Enrolled participants – demographics:
Eight patients, who met the inclusion criteria based on their A&E admission notes were approached by the study team within 24 hours of their admission and consented to participate in the study.
The average age of the participants was 54.75 years. 75% (6) of the participants were male, of which the age range was 54 to 74 years old. The two (25%) female participants were both 24 years old.
Three of the eight participant’s ethnicity was White, three participants defined their ethnicity as Asian or Asian British (Indian) and the remaining two participants identify as Mixed (white & Asian) ethnicity.
Four (50%) of participants were non-smokers, three ex-smokers and one was a current smoker at time of enrolment.
Enrolled participants
Aetiology
• All participants enrolled into the study had received a diagnosis of an ARI (Acute Respiratory Infection), confirmed or probable on admission to hospital.
• All had a history of sudden onset of illness with a self-reported fever or temperature of more than 38 degrees, a cough and tiredness.
• 50 % of the 8 participants received a positive PCR swab for SARA-CoV-2, while the remaining 4 had no causative pathogen found in routine care.
• All 4 of the participants who had a confirmed SARS-CoV-2 infection had a raised C-Reactive Protein (CRP) blood test (range: 69.7-270.7mg/L) and a raised lactate (range: 392-604u/L).
• The average length of stay in hospital for all enrolled participants was 18 days.
• 6 participants required supplementary oxygen during their admission, for an average of 9.3 days.
• Two of the 3 with confirmed SARS-CoV-2 ARI required supplementary oxygen and one required mechanical ventilation in Intensive Care for 22 days.
• The one participant who was admitted to Intensive Care with an acute lung injury/ARDS had an additional complication of a tracheostomy site infection, found to be staphylococcus – aureus, before discharge.
• None of the participants were found to have a pleural effusion on Chest X-ray.
Clinical Management and outcome
• Five participants, 3 of which with confirmed SARS-CoV-2 infection, received a steroid treatment. Predominantly Dexamethasone orally or intravenously. One participant received an inhaled steroid and oral prednisolone.
• 7 participants received a treatment course of antibiotics from the penicillin family. Three of those participants also received a cephalosporin 3rd generation antibiotic.
• One participant did not receive any antibiotics, this participant did not have a confirmed causative respiratory pathogen found.
• Four participants received Remdesivir (antiviral), three of which had a positive PCR test for SARS-CoV-2, one without.
• All participants were alive at point of discharge and discharged home.Secondary Objectives Results:
No comparative analysis (mediator levels or transcriptomics) has gone ahead on the samples collected from participants in this study, due to to insufficient recruitment.REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0234
Date of REC Opinion
10 Nov 2020
REC opinion
Further Information Favourable Opinion