AFLOAT
Research type
Research Study
Full title
Antibiotics versus placebo for acute lower respiratory tract infection in older adults
IRAS ID
1010353
Contact name
Mark Lown
Contact email
Sponsor organisation
university of Southamtpon
ISRCTN Number
ISRCTN11309776
Research summary
AFLOAT is a two-arm, double blinded non-inferiority trial at multiple primary care sites.
LRTI are the most common reason for antibiotic prescription in the UK, despite most infections being viral in origin, to which antibiotics confer no meaningful results. Older people, aged 75+ are prescribed more antibiotics than any other age group in the U.K. LRTI was estimated to cost the NHS ≈£190 million in 2005. Older people are at increased risk of a prolonged and more severe illness, development of pneumonia and exacerbation of pre-existing chronic conditions. Whether older patients with risk factors for complications benefit from antibiotics is unknown and NICE guidance recommends considering immediate or delayed antibiotics for this group when presenting with non-complicated LRTIs. This leaves prescribing clinicians with frequent dilemmas over whether to prescribe antibiotics in this patient population. Antibiotic overuse can increase the risk of carriage of antibiotic-resistant organisms, which is a threat both for the individual treated and wider society. Antibiotic prescriptions also lead to medicalisation of self-limiting illness and double re-consultation rates. However, under-prescription of antibiotics may put older people at increased risk of prolonged and more severe illness and pneumonia
Research question - Whether placebo is non-inferior to antibiotics. Aim - assess whether duration of illness (time until all symptoms are rated absent or mild) is no worse in those who take placebo vs antibiotics in adults aged 65 or over who are seen in primary care with LRTI and risk factors for complications.
Adults aged 65 and over with symptoms of uncomplicated LRTI and 1 or more risk factors for complications (age > 80, recent hospital admission, chronic conditions, frailty). Participants will be randomised into the doxycycline arm or matched placebo arm and asked to complete a daily diary for a 28 day follow-up period.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0205
Date of REC Opinion
16 Oct 2024
REC opinion
Further Information Favourable Opinion