RecruitingOBSERVATIONAL

Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy

Many children are thought to be allergic to common antibiotics, but most of them aren't truly allergic. This often means they get different, sometimes less effective, medicines. This study wants to see if a simple test, called a direct oral challenge, can be done safely in a private doctor's office instead of only in hospitals. The test involves giving a small amount of the antibiotic under close watch to see if there's a reaction. It's specifically for children who had a mild, delayed reaction in the past, like a simple rash, and not severe reactions. This could help more children find out if they can safely take these important antibiotics.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

200

Start

01 Jun 2026

Estimated completion

01 Jun 2027

Allergy

What is this study about?

When a child has a reaction to an antibiotic, like penicillin, doctors sometimes label them as being allergic. This can lead to them getting different antibiotics in the future, which might not work as well or could have more side effects. However, for many children, this allergy label isn't actually correct. In fact, only about 5 to 10 out of every 100 children truly have a beta-lactam allergy.

For children who had a mild, delayed reaction in the past (like a rash appearing more than an hour after taking the medicine), there's a special test called a 'direct oral challenge'. This test involves giving the child a small, controlled amount of the antibiotic under medical supervision to see if they react. Experts believe this is the best way to check for these types of allergies. The study aims to find out if this test can be done safely and effectively in a private doctor's office, not just in a hospital.

The main goal is to help more children remove the 'allergy' label if they're not truly allergic. This would mean they could then safely take common and often more effective antibiotics when they need them, potentially leading to better health and fewer problems from infections.

Key takeaways

Many children are wrongly labelled as allergic to common antibiotics.
A special test called an oral challenge helps confirm true allergies.
This study explores if oral challenges can safely happen in private doctor's offices.
It focuses on children with past mild, delayed reactions to antibiotics.
The goal is to improve access to testing and reduce unnecessary antibiotic restrictions.
No new tests or medicines are involved for this specific study.

Who may be eligible?

This study is for children aged 0 to 17 years old who have previously had an oral challenge test at a private doctor's practice.

To be included, the child must have had a suspected mild, delayed reaction to certain antibiotics like amoxicillin (which sometimes comes with clavulanate), cefpodoxime, or cefixime. A delayed reaction means it happened more than an hour after taking the medicine, and a mild reaction would be something like a simple skin rash, not a severe one.

Children cannot take part if their reaction was very severe (for example, blistering skin, swelling of the face, or affecting organs like the eyes or mouth, or if they felt very unwell). Also, children or their parents who don't agree to their health information being used in the study will not be included.

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 0 to 17?
Has your child previously had a direct oral challenge in a private medical practice?
Was their past reaction to amoxicillin, cefpodoxime, or cefixime?
Did their reaction happen more than an hour after taking the medicine?
Was the reaction mild, like a simple rash, and not severe?
Do you agree for your child's de-identified medical data to be used in research?

Answer every question to see your result.

What does participation involve?

This study looks back at information from children who have already had a direct oral challenge in a private medical practice. You wouldn't be undergoing a new test specifically for this study. Instead, the researchers would be reviewing patient records from children who had this test and a follow-up appointment within 7 to 14 days. There are no direct appointments or medication to take for the purpose of this study itself.

Potential risks and benefits

This study is a review of existing information, so there are no direct risks or benefits to individuals who have already had the procedure. The potential benefit is that the study's findings could help more children safely get tested for antibiotic allergies in a doctor's office, reducing unnecessary antibiotic restrictions for many. Your right to withdraw your child's data from the study, if they were included, would be respected at any time.

Locations (1)

Hôpital Necker - Enfants Malades
Verified postcode
Paris, France· Recruiting

Common questions

What is a 'direct oral challenge'?

It's a test where a small, controlled amount of an antibiotic is given to a child, under medical supervision, to see if they truly have an allergic reaction.

Why is this study important?

Many children are wrongly thought to be allergic to antibiotics. This study aims to help confirm if this testing can be safely done outside of hospitals, making it easier for more children to get a definitive answer.

What is a 'beta-lactam' antibiotic?

These are a common type of antibiotic, including medicines like penicillin and amoxicillin, often used to treat infections.

What does 'benign delayed allergy' mean?

It refers to a mild allergic reaction, like a rash, that appears more than an hour after taking a medicine, and isn't usually dangerous.

Will my child need to take any new medicine for this study?

No, this study only looks at information from children who have already had the oral challenge test and follow-up appointment.

How to find out more

Sebastien LE, MD

sebastien.le@aphp.fr 06 35 14 12 41 Official trial record

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