AuthorisedTherapeutic confirmatory (Phase III)Interventional

PHASE III, OPEN-LABEL, RANDOMIZED, CONTROLLED, NON-INFERIORITY CLINICAL-TRIAL TO ASSESS THE EFFICACY AND SAFETY OF SHORT OUTPATIENT AMOXICILLIN REGIMENS IN CHILDREN WITH ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS (STOP – TRIAL)

This research study is looking for children with a common throat infection called strep throat, caused by specific bacteria. Doctors want to find out if shorter courses of a common antibiotic called amoxicillin are as good as longer ones for treating this infection. The study aims to confirm if these shorter treatments can prevent the infection from returning and avoid other health problems, while still being safe for children. By comparing different treatment lengths, researchers hope to find the best way to help children recover quickly and stay healthy, potentially making treatment simpler and easier for families.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Enrolment target

500

Start

08 Jun 2026

ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS

What is this study about?

Imagine your child has a sore throat that the doctor says is strep throat. This infection is caused by a type of bacteria. Usually, doctors give antibiotics for a certain number of days to make sure the infection clears up completely and doesn't lead to more serious problems.

This study is all about finding out if we can use shorter courses of a common antibiotic called amoxicillin to treat strep throat in children. The researchers want to see if these shorter treatments work just as well as the usual longer ones. This means checking if they can stop the infection from coming back and prevent other issues, all while being safe for children. They will compare different short treatment plans to understand which one is most effective.

Why does this matter? If shorter treatments work just as well, it could mean children take fewer medicines, which might be easier for families and could help reduce the chances of antibiotic resistance in the long run. The study will carefully look at whether the strep throat comes back after treatment and if any other complications develop, like ear infections or more serious conditions, to make sure the shorter treatments are truly effective and safe.

Key takeaways

This study evaluates shorter amoxicillin courses for children's strep throat.
It aims to see if shorter treatments are as safe and effective as standard ones.
The goal is to prevent the infection from returning and avoid complications.
Children will be followed for about four months after finishing treatment.
Participation could lead to improved strep throat treatment options.

Who may be eligible?

Generally, this study is open to children who have been diagnosed with strep throat, which is a specific type of throat infection.

There are no specific age limits mentioned, meaning children of any age with strep throat might be able to take part. The study includes both boys and girls.

To know for sure if your child can join, it's really important to talk to their doctor or the study team. They will check your child's full medical history and current health to see if it's the right fit.

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 a diagnosis of strep throat?
Is your child able to take amoxicillin?
Are you able to bring your child for follow-up appointments?
Are you comfortable with your child potentially receiving a shorter course of antibiotics?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will likely be given a course of amoxicillin, an antibiotic commonly used for strep throat. They will be assigned to one of several treatment plans, each with a different, shorter length of treatment than usual. After finishing the medication, doctors will regularly check on your child for about four months to see how they are recovering.

During this time, they will monitor for signs of the strep throat infection returning and check for any other health issues, such as fever, ear infections, or other complications. This will involve appointments with the medical team, which might include throat swabs and other basic checks. The total duration of follow-up will be around four months from when your child finishes their antibiotic treatment.

Potential risks and benefits

Taking part in this study could potentially help find a more effective and simpler way to treat strep throat in children, benefiting many families in the future. As with any medication, there's a small chance your child might experience side effects from the antibiotic, such as an upset stomach or a rash. The study doctors will carefully monitor your child for any problems. It's important to remember that joining a study is always voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual 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
Spain

Common questions

What is strep throat?

Strep throat is a common throat infection caused by specific bacteria, leading to a sore throat, fever, and sometimes other symptoms.

What is amoxicillin?

Amoxicillin is a common antibiotic medicine used to treat various bacterial infections, including strep throat.

Why are they studying shorter treatments?

Researchers want to see if shorter antibiotic courses are just as effective and safe, which could make treatment easier and reduce potential problems like antibiotic resistance.

Will my child still get treatment if they don't join the study?

Yes, if your child has strep throat, their doctor will provide the best standard treatment available, whether or not they participate in the study.

How long will my child be followed up if they join?

If your child participates, they will be followed for about four months after they finish taking their antibiotic medicine.