Every year, GPs prescribe antibiotics to 87% of older patients who come in with a cough or bronchitis, even though most of these infections are caused by viruses that antibiotics cannot treat. This matters because the evidence for giving antibiotics to people aged 65 and over with uncomplicated lower respiratory tract infections (LRTI) is essentially absent. Current NICE guidance tells GPs to “consider” antibiotics for this group, leaving them in a bind: prescribe and risk fuelling antibiotic resistance, or withhold and risk a patient developing pneumonia. Older adults are the heaviest users of antibiotics in the UK, yet no trial has tested whether the drugs actually help them recover faster. The AFLOAT trial will give 65+ patients with LRTI and at least one risk factor (such as frailty, a chronic condition, or age over 80) either doxycycline or a placebo. If the placebo group recovers just as quickly—meaning symptoms are gone or only mild—then GPs can safely stop prescribing for this group. That would cut unnecessary antibiotic use, reduce patient harm from side effects, slow the spread of resistant bacteria, and save the NHS millions currently spent on drugs that do not work for viral infections.
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Research Question Is the time until all symptoms are rated by patients as absent or only “mild” no worse in those who take placebo compared with those who take antibiotics in adults aged 65 or over who are seen in primary care with uncomplicated Lower Respiratory Tract Infection (LRTI) and risk factors for complications. Background Acute cough and bronchitis are the most common reasons for antibiotic prescribing in UK primary care and were estimated to cost the NHS ~£190 million per year in 2005. When pneumonia is not suspected, most LRTI in adults is caused by viruses and antibiotics confer no meaningful benefit. However, 87% of patients consulting for LRTI are prescribed antibiotics, and people aged 75+ are prescribed more antibiotics than any other age group. Older people are at increased risk of a prolonged and more severe illness, development of pneumonia and exacerbation of pre-existing chronic conditions. However, whether older patients with risk factors for complications benefit from antibiotics is unknown, and NICE guidance recommends considering antibiotics for this group. This leaves prescribing clinicians with frequent dilemmas over whether to prescribe antibiotics to older adults with uncomplicated LRTI or not. Antibiotic overuse can increase the risk of carriage of antibiotic-resistant organisms, which is a threat both for the individual and all humankind. Antibiotic prescriptions for cough also lead to medicalisation of self-limiting illness and double re-consultation rates. On the other hand, under-prescription of antibiotics may put older people at increased risk of prolonged and more severe illness and pneumonia. When surveyed, GPs have rated ‘infections in the elderly’ as the top priority for all infection research and would like more evidence to guide their practice. In another survey, older adults were cautious about antibiotic use, side effects and resistance. Aims and objectives To determine if placebo is not inferior to antibiotics in terms of time until all symptoms are rated absent or mild in adults aged 65 and over who are seen in primary care with uncomplicated LRTI and risk factors for complications. Methods A 2-arm, double-blinded, multi-centre, non-inferiority trial. Inclusion: Adults aged 65 or more with at least moderately severe symptom of uncomplicated LRTI and at least 1 risk factor for complications (age > 80, recent hospital admission, chronic conditions, frailty). Intervention: Doxycycline 100 mg twice a day on the first day then 100 mg once a day for four days. Control: Matched placebo. Primary outcome: duration of illness (time until all symptoms are rated absent or mild). Secondary outcomes include symptom severity, deterioration of illness, reconsultation rates, hospital admissions, activities of daily living and quality of life. A cost-consequences analysis will be conducted alongside the trial. Timelines for delivery The study will start in January 2024 and run for 48 months. Anticipated impact and dissemination If placebo is shown to be non-inferior, widespread implementation and greater antimicrobial stewardship in collaboration with patients, NICE and the NHS will reduce exposure to antibiotics leading to reductions in patient harm and antimicrobial resistance. We will disseminate our findings via scientific papers and conferences, patient groups, a stakeholder dissemination event, social and conventional media, and other stakeholder engagement.
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