RecruitingPhase IVInterventional

A shorter duration of antibiotic treatment versus a longer duration of antibiotic treatment for patients with a flare-up of their chronic lung condition requiring intravenous antibiotics

Bronchiectasis is a long-term lung condition that causes airways to widen, leading to mucus build-up and chest infections known as flare-ups. When flare-ups are severe, doctors usually prescribe antibiotics directly into a vein (intravenously) for 14 days. However, there is little scientific proof that two full weeks is necessary. The SBIVA study compares a 7-day course of intravenous antibiotics against the standard 14-day course in 400 UK adults. An earlier small study suggested that a shorter course helped people stay free from their next flare-up for longer, with fewer side effects and less time spent on treatment. If you take part, you will be placed by chance into either the 7-day or 14-day group. Both groups receive standard NHS care and will be followed up for one year. This research could help doctors prescribe antibiotics more safely and effectively.

At a glance

Status

Recruiting

Phase

Phase IV

Enrolment target

382

Start

31 Jul 2023

Estimated completion

30 Nov 2027

Bronchiectasis

What is this study about?

Bronchiectasis is a long-term chest condition where the airways become widened and scarred. This allows mucus to build up, making the lungs prone to infections. When symptoms suddenly worsen—such as increased coughing, changes in phlegm, or breathlessness—it is called a flare-up. For severe flare-ups, doctors often treat patients with antibiotics given straight into a vein through a small tube or drip (intravenous antibiotics).

Currently, medical guidelines recommend that patients receive intravenous antibiotics for 14 days. However, this advice is based on expert opinion rather than clinical trial evidence. Taking antibiotics for two weeks can mean spending more time in hospital or attached to drips at home, and it increases the risk of side effects. On the other hand, stopping treatment too early might allow the infection to return quickly. Doctors need clear evidence to find the best balance.

A smaller study in Edinburgh showed promising results: patients who received just 7 days of intravenous antibiotics actually waited longer before their next flare-up compared to those who had 14 days. The SBIVA trial now aims to test this in 400 people across the UK. If a shorter course works just as well, it could reduce antibiotic side effects, lower the risk of bacteria becoming resistant to medicines, and update treatment guidelines worldwide.

Key takeaways

The study tests whether 7 days of intravenous antibiotics works as well as the usual 14 days for bronchiectasis flare-ups.
It is open to UK adults aged 16 and over who need drip antibiotics for a flare-up.
A computer randomly decides whether you receive a 7-day or 14-day antibiotic course.
You will be followed up for 12 months via monthly phone calls and simple questionnaires.
A shorter course could mean fewer side effects, less hospital time, and reduced antibiotic resistance.

Who may be eligible?

This study is open to adults aged 16 and over who have an established diagnosis of bronchiectasis, confirmed by a CT scan or a specialist doctor. To be considered, you must currently be having a flare-up of your chest symptoms that your medical team agrees needs treatment with intravenous (drip) antibiotics.

You will not be able to join if you have cystic fibrosis or active tuberculosis (TB). The trial is also not suitable for people who are pregnant, planning to become pregnant during the study, breastfeeding, or those receiving end-of-life care.

Finally, you cannot take part if you have a known allergy to meropenem and the alternative antibiotics used in the study, if you have already taken part in the SBIVA trial previously, or if your doctor feels that participating would not be in your best medical interest.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 16 or over.
I have a confirmed diagnosis of bronchiectasis (supported by a CT scan).
I am currently having a chest flare-up that requires intravenous (drip) antibiotics.
I do not have cystic fibrosis or active tuberculosis.
I am not pregnant, planning a pregnancy, or breastfeeding.

Answer every question to see your result.

What does participation involve?

If you decide to join, a computer will randomly place you into one of two groups: one group receives intravenous antibiotics for 7 days, and the other receives them for 14 days. Both you and your doctor will know which group you are in, and you will continue to receive all your normal NHS respiratory care.

Your participation will last for 12 months. During this year, the research team will keep in touch through monthly phone calls arranged at times that suit you. You will also be asked to complete simple health questionnaires, either online or on paper. Occasionally, you will be asked to collect a phlegm (sputum) sample and send it to the team using a pre-paid postal pack.

Potential risks and benefits

If you are assigned to the 7-day group, potential benefits include fewer days on a drip, fewer medication side effects, and potentially a longer time before your next flare-up. If you are in the 14-day group, you will receive the current standard NHS care. The main inconvenience is the time needed to answer monthly telephone calls, fill in surveys, and post sputum samples. There are no extra medical procedures beyond your standard care. Taking part is entirely voluntary, and you can withdraw at any point without giving a reason and without your usual medical care being affected.

Locations (1)

Royal Infirmary of Edinburgh
Approximate
Edinburgh, Scotland

Common questions

Will I be given an untested, experimental medicine?

No. All the antibiotics used in this study are already approved, standard medicines routinely used by the NHS to treat chest infections.

Can I choose whether I receive 7 or 14 days of antibiotics?

No. A computer randomly allocates you to one of the two groups so that the results can be compared fairly and accurately.

What happens if I still feel unwell after 7 days?

Your clinical care team will continue to monitor you closely. If your doctor believes you need further treatment, your health and safety will always come first.

Do I have to travel to extra hospital appointments?

Most study follow-ups are designed to be convenient and take place from home through monthly telephone calls and postal questionnaires.

Can I leave the study if I change my mind?

Yes. You can leave the study at any time without having to give a reason, and your normal NHS care will continue as usual.

How to find out more

Public Contact

research@asthmaandlung.org.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.