Title

AfLOAT – Antibiotics For uncomplicated LRTI in Older AdulTs

Description

Acute cough is a common reason for antibiotic prescribing in UK primary care.  Trials have shown that most adults with lower respiratory tract infection (LRTI) do not benefit from antibiotics when pneumonia is not suspected. However, age >75 and co-morbidity have been shown to be independent predictors of complications in adults with LRTI. Whether or not older adults with risk factors benefit from antibiotics is unknown.

Over-prescribing antibiotics risks unnecessarily exposing patients to adverse effects and can increase the risk of carriage of antibiotic-resistant organisms, which is a threat both for the individual who has taken them and wider society. 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. This leaves prescribing clinicians with a frequent dilemma of whether to prescribe antibiotics to older adults with uncomplicated LRTI.

The AfLOAT study is being conducted to determine whether the duration of moderate or more severe symptoms is 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 LRTI and risk factors for complications. This will help clinicians and patients to make decisions about best use of antibiotics in the future.

Objectives

Primary:

• To test whether placebo is non-inferior to oral doxycycline in terms of the duration of moderate or worse symptoms in adults aged 65 or over presenting in primary care with uncomplicated LRTI and risk factors for complications.

Secondary:
To estimate the effect of the intervention on:

• Deterioration of illness (return to the doctor with a worsening of symptoms, new symptoms, signs, or illness requiring hospital admission or death within four weeks). 
• Symptom severity during days 2-4 after the index consultation (symptoms are rated as the worst problem by patients during this time-period).
• Use of antibiotics over the 28 days following enrolment.
• Time until return to usual activities (effect on usual activities rated as ‘no problem’). 
• Total symptom score over time.

Health Economic:

• To estimate mean (sd) resource use and costs per participant per treatment group over 28 days and mean difference (95% CI) in resource use and costs per participant between groups. 
• To estimate mean (sd) utility at each time point and mean (sd) Quality Adjusted Life Years (QALYs) per participant per treatment group and mean difference (95% CI) in utility and QALYs between groups. Health-related Quality of life is measured using the EQ-5D-5L. 
• To present descriptively the costs and consequences of replacing antibiotic with placebo.

Trial Design:

Randomised, 2-arm, blinded, multi-centre, non-inferiority trial with a 9-month internal pilot.

Trial Status:

In set-up

Population:

Adults aged 65 and over presenting in primary care with at least moderate symptoms of uncomplicated LRTI and 1 or more risk factors for complications (age > 80, recent hospital admission, chronic conditions, frailty).

Funder:

NIHR (HTA) – Application ID NIHR157478