What is the AfLOAT study?

Background

Antibiotics are often prescribed for people who see their GP about cough. However, most coughs are caused by viruses and antibiotics don’t help symptoms get better more quickly. Therefore, national UK guidelines discourage the use of antibiotics for most people with cough. Older people with ongoing health conditions who develop a cough have an increased risk of this developing into a more severe illness and are frequently prescribed antibiotics. However, we don’t know if antibiotics are helpful for these people.

This study aims to assess whether antibiotics are helpful for older people with a chest infection. Specifically, people who are aged 65 or more who have one or more risk factors for complications and are being seen in primary care (e.g. a general practice) for a chest infection that is not diagnosed as pneumonia. 

We will do this by seeing if the duration of illness is ‘no worse’ in those who take a placebo (a capsule that looks like the antibiotic but contains no medication) compared with those who take antibiotics.

Who can participate?

Adults aged 65+ who have symptoms of a chest infection and have one or more of the following risk factors for complications:

•  Age 80 or over (no other risk factors are needed if age 80 or over)
•  Have had at least one unplanned hospital admissions in the past 12 months

• Have diabetes (Type 1 or 2), chronic cardiovascular disease, chronic lung disease, chronic kidney disease, chronic liver disease, chronic neuromuscular disease (chronic condition of the nerves and or muscles that cause weakness).
• Have at least mild ‘frailty’ as defined using a score which is used by some healthcare professionals (Clinical Frailty Scale).

What does the study involve?

Participants will be randomly allocated (like the toss of a coin) to one of two groups, either being assigned to a five-day course of oral (taken by mouth) antibiotics called doxycycline, or a dummy capsule (known as a placebo) which looks the same as the antibiotic capsules.

Participants will be asked to record a daily patient diary, either online or in paper format for up to 28 days, including scoring the severity of their symptoms, and some additional short questions.

What are the possible benefits and risks of participating?

The main reason for this research study will be to provide good evidence on the impact of antibiotic treatment for chest infection in older adults at risk of complications in the community. The results of this study will help health care professionals inform future patients about the potential benefits and risks of taking antibiotics. 

Potential risks include:

• having to revisit your GP if your symptoms worsen and you require additional prescriptions,
• potential side effects of the antibiotic (doxycycline)
• additional time spent filling out questionnaires that would not normally be asked of you if you were not part of the trial