Antivirals for influenza like illness? An RCT of clinical and cost effectiveness in primary care
This study will determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity. It will also investigate the clinical cost and effectiveness of the addition of antivirals to usual care initially oseltamivir, but the adaptive design will allow the addition of new antiviral throughout the 3 years of the trial. The study will also look at sub-groups and how they respond to different treatments allowing analysis throughout the trial. The trial will also test a new point of care test for influenza. A qualitative research component will review barriers to recruitment in infectious disease research.
Infectious diseases are a major threat to human wellbeing and economic and social development. Influenza, a highly contagious virus, causes a common respiratory infection with local and systemic symptoms. Patients with influenza can develop complications such as pneumonia, otitis media, encephalopathy or other secondary bacterial infections. Annual influenza epidemics cause substantial morbidity and mortality and the 2009 H1N1 influenza outbreak was defined as a pandemic by the World Health Organisation (WHO). The ALIC4E trial will be delivered as work package (WP) 4 of the Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) consortium grant. PREPARE is a European Commission funded network for the rapid and efficient delivery of harmonised, large-scale clinical research studies on infectious diseases (ID).
PREPARE aims to develop the capability to rapidly implement prospective clinical research during pandemics to provide real-time evidence to inform the clinical management of patients and for informing public health responses to outbreaks.
|Study Design:||Open adaptive-platform randomised design trial|
|Sponsor:||University of Oxford|
|Ethical Approval:||REC No: 15/SC/0138|
|Chief Investigator:||Professor Chris Butler, University of Oxford|