AuthorisedTherapeutic confirmatory (Phase III)Interventional

SPARE : Evaluation of a therapeutic strategy to reduce the duration of antibiotic therapy for community-acquired alveolar pneumonia in children: a randomized controlled non-inferiority trial

This study, called SPARE, is investigating the best length of antibiotic treatment for children who get a chest infection called pneumonia. Specifically, it's looking at whether a shorter course of amoxicillin – a common antibiotic – is just as effective as the current longer standard treatment. Researchers want to find out if reducing the time children take antibiotics can still properly cure the infection and prevent it from coming back, without causing more problems. The study focuses on children of all ages and genders and is designed to ensure any new approach is safe and works well. This is important because using antibiotics for the right amount of time helps children feel better and can reduce potential side effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Montpellier

Enrolment target

1,100

Start

30 Aug 2024

Community-acquired alveolar pneumonia in children

What is this study about?

This research, known as the SPARE study, is all about finding the best way to treat a common lung infection in children called pneumonia. When children get pneumonia, they are usually given antibiotics like amoxicillin to help them get better. Doctors want to know if giving antibiotics for a shorter period of time is just as good as giving them for the usual longer period.

The main goal of the study is to see if children treated with a shorter course of antibiotics get better just as quickly and effectively as those on a longer course. They will be watching to see if the infection goes away properly, if children need to go back to the hospital, or if the infection gets worse. They will also look at whether children need to take more or different antibiotics because the first treatment didn't work.

This kind of study is important because finding the right length of antibiotic treatment can help children recover while also lowering the risk of side effects from the medication. It could also help reduce the problem of antibiotics not working as well in the future (antibiotic resistance) by using them only when and for as long as truly needed.

Key takeaways

The study aims to find the ideal length for antibiotic treatment in children with pneumonia.
It compares shorter antibiotic courses with traditional longer ones.
The main antibiotic being studied is amoxicillin.
Researchers will check if shorter treatment is just as safe and effective.
Participation involves taking amoxicillin and attending follow-up checks for about 30 days.
The study includes children of all ages and genders with this specific type of pneumonia.

Who may be eligible?

This study is open to children who have been diagnosed with a type of lung infection called community-acquired alveolar pneumonia. This means they got the infection outside of a hospital setting.

There are no specific age limits; children of any age can be considered for the study. Both boys and girls are able to take part if they meet the other study requirements.

Your doctor will check other specific health details to make sure the study is a good fit for your child. It's important that your child fits all the criteria to ensure the study results are clear and helpful for other children in the future.

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.

Does your child have community-acquired alveolar pneumonia?
Is your child able to take amoxicillin?
Are you able to attend follow-up appointments?
Do you understand that your child will be randomly assigned a treatment length?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive a common antibiotic called amoxicillin. They will either be given a shorter course of this antibiotic or the usual longer course, decided by chance.

During the study, there will be a few check-ups. You'll have visits around 7 days and 30 days after starting the treatment. At these visits, doctors will check how your child is feeling, if their cough or fever has improved, and if the infection is going away. They will also ask about any side effects your child might be having from the medication.

The total participation will likely involve these close observations and check-ups for up to 30 days to see how well the treatment worked and if there were any issues.

Potential risks and benefits

Taking part could help doctors understand the best and safest way to treat pneumonia in children, potentially leading to shorter antibiotic courses in the future. As with any medication, amoxicillin can have side effects, such as tummy upsets or allergic reactions, which the study team will monitor closely. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'community-acquired alveolar pneumonia'?

It's a common type of lung infection (pneumonia) that children get outside of a hospital setting, which affects the small air sacs in the lungs.

What is amoxicillin?

Amoxicillin is a common antibiotic used to treat bacterial infections, including many types of pneumonia.

What does 'non-inferiority' mean in this study?

It means the study aims to show that a shorter antibiotic treatment is just as good as (not worse than) the standard longer treatment.

Will my child definitely get a shorter course of antibiotics?

No, your child will be randomly assigned to either a shorter course or the usual longer course. This is done by chance, like flipping a coin.

What if my child doesn't get better on the study medication?

The study team will closely monitor your child. If they don't improve or get worse, their treatment will be changed as needed by their doctor to ensure they receive appropriate care.