RecruitingPHASE2, PHASE3INTERVENTIONAL

Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.

This study is looking at the best way to treat a common lung infection called pneumonia in children. Specifically, it wants to see if giving a common antibiotic medicine called amoxicillin twice a day is just as effective as giving it three times a day. Children aged 3 months to 18 years who come to A&E with a non-serious lung infection might be able to take part. The main aim is to check if the medicine works to clear the infection and prevent children from needing to come back to hospital or change their medicine. This could make taking medicine easier for children and their families.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

St. Justine's Hospital

Enrolment target

1,370

Start

11 Jun 2017

Estimated completion

01 Jun 2027

Community-acquired Pneumonia

What is this study about?

This study is about finding the best and easiest way to treat a common lung infection called pneumonia in children. You might hear this infection called 'community-acquired pneumonia' because it's caught outside of a hospital setting. The main goal here is to see if giving an antibiotic medicine called amoxicillin just twice a day works as well as giving it three times a day.

At the moment, many children with this type of pneumonia might take amoxicillin three times a day. But if taking it twice a day is just as effective, it could make life much simpler for children and their families. It can be hard to remember to give medicine multiple times a day, especially during busy school days or when trying to stick to routines. This study wants to find out if we can offer the same good treatment with less fuss.

Doctors are particularly interested in children who have a non-serious form of pneumonia. They will be watching closely to see if the infection clears up properly, if children need to return to hospital, or if their medicine needs to be changed for any reason like the fever not going away. They will also look at how children feel overall and if there are any side effects from the medicine, to make sure the new approach is safe and effective.

Key takeaways

This study compares two ways of giving amoxicillin for children's pneumonia: twice a day vs. three times a day.
It aims to find an equally effective but potentially easier treatment schedule.
Participation involves receiving amoxicillin and follow-up checks over time.
Children aged 3 months to 18 years with non-serious pneumonia are being considered.
You can withdraw your child from the study at any time without affecting their care.

Who may be eligible?

This study is designed for children aged between 3 months and 18 years old who come to a children's A&E department. To be considered, they must have symptoms of a lung infection, like a cough and trouble breathing, along with signs a doctor can spot, such as fast breathing or crackling sounds in their chest. They also need to have a fever and an X-ray that confirms they have pneumonia.

However, some children won't be able to join the study. This includes those with very serious signs of pneumonia (like severe trouble breathing or very low blood pressure), or if they've had a bad allergic reaction to penicillin or amoxicillin before. Children with certain long-term conditions like cystic fibrosis or weakened immune systems, or those who have had pneumonia before in the last month, also wouldn't be able to take part. Also, if a parent or guardian can't give permission due to language or not being present, the child can't join.

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.

Is your child aged between 3 months and 18 years?
Does your child have a cough and trouble breathing (respiratory symptoms)?
Does your child have a fever?
Has a doctor confirmed pneumonia with a chest X-ray?
Does your child NOT have severe breathing problems or other serious pneumonia signs?
Has your child NOT had a serious allergic reaction to penicillin or amoxicillin before?

Answer every question to see your result.

What does participation involve?

If your child takes part, they'll be looked after at a children's A&E department. They will be given amoxicillin, either twice or three times a day, as decided by chance by a computer. Doctors will then check on their health over the next 10 days to see how well the medicine is working. This involves looking for things like if their fever goes away, if they need to go into hospital, or if their medicine needs to be changed.

There will also be follow-up checks. These look at things like if your child needs another course of antibiotics, or if they get a lung infection again. Doctors will also want to know about any side effects, how many days your child missed from school or nursery, and how happy you and your child are with the treatment. The total duration of the study for your child will be a check-up over the first 10 days and some follow-up throughout the next month or so.

Potential risks and benefits

Taking part could mean your child receives a treatment that's easier to manage (twice daily) while still being very effective. All medicines carry some risk of side effects; amoxicillin is generally safe but can cause tummy upsets or rashes in some children. Doctors will carefully monitor your child for any problems. You are entirely free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

CHU Sainte-Justine
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is pneumonia?

Pneumonia is a common infection in the lungs that can make breathing difficult. It can be caused by germs like bacteria or viruses.

What is amoxicillin?

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

What does 'non-serious' pneumonia mean?

It means the pneumonia isn't severe enough to cause immediate life-threatening problems, but still needs treatment.

Will my child definitely take the medicine twice a day?

No, it's decided by chance, like flipping a coin. Your child will either get the medicine twice a day or three times a day.

Who is paying for this study?

The information doesn't say who is funding the study, but studies like this are often funded by medical research groups or universities.

How to find out more

Jocelyn Gravel, MD

graveljocelyn@hotmail.com 514-345-4931 Official trial record

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