All studies
RecruitingNAINTERVENTIONAL

Impact of Bacterial Expression and Immune Response in the Severity of Pertussis

Whooping cough, or pertussis, is on the rise, and we want to find out why. Some scientists think the way the bacteria that cause whooping cough are evolving, possibly due to our current vaccines, might be making the illness worse or harder to fight. We know very little about why some children get a mild form and why others, especially babies, can become critically ill, with some sadly not surviving. This study will collect information and samples from children with whooping cough to look closely at these changing bacteria and how children's immune systems respond. Our goal is to discover new ways to predict who might get very sick and find better options for future vaccines.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Institut Pasteur
Enrolment target
210
Start
16 Nov 2023
Estimated completion
16 Nov 2026

What is this study about?

Whooping cough, also known as pertussis, can be a serious infection, especially for very young babies. We're seeing more cases of whooping cough lately, and scientists are trying to understand why. One idea is that the bacteria causing whooping cough might be changing over time, possibly because of the vaccines we currently use. These changes could be making the infection harder to fight or causing more severe illness.

At the moment, it's not clear why some children only get a mild case of whooping cough, while others, particularly babies, can become extremely ill. In the most severe cases in infants, sadly, many do not survive. We also don't have good ways to predict which children might develop a very serious form of the disease.

This study aims to tackle these important questions. We will work with children who have whooping cough to gather information and samples. By looking closely at how the bacteria are changing and how the children's bodies respond to the infection, we hope to find clues. Our ultimate goal is to discover ways to predict who might get very sick and to develop better ways to prevent whooping cough in the future, especially for our most vulnerable children.

Key takeaways

  • The study investigates why whooping cough is increasing and becoming more severe.
  • It focuses on how whooping cough bacteria are changing and how children's bodies fight the infection.
  • The goal is to find ways to predict severe illness and improve vaccines.
  • Participation involves collecting health information, a nose swab, and a blood sample.
  • There are no new medicines given as part of the study.
  • Results could help many children in the future.

Who may be eligible?

Children can take part in this study if they are between 0 and 15 years old. They must be suspected by their doctor to have whooping cough, and their doctor must have ordered a specific test (called a PCR) to confirm this. Importantly, children cannot have any other health conditions or be taking any medicines that might affect their immune system, as this could make the study results unclear. This includes conditions like autoimmune diseases or taking high doses of steroids for a long time. Their parents or guardians must also give their written permission for them to join.

Children cannot take part if they have a condition or are taking medication that affects their immune system. Also, if they have been given antibiotics that treat whooping cough within 24 hours before samples are taken, they can't join. The study also has a time limit: if too much time passes between the whooping cough test result and the day they might join the study, they won't be able to participate. Finally, very small babies (under 2.5 kg) or those whose doctors think taking part wouldn't be safe for them, cannot 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.

  1. Is my child between 0 and 15 years old?
  2. Does their doctor suspect they have whooping cough and have they ordered a specific test (PCR)?
  3. Does my child have any health conditions or take medicines that affect their immune system?
  4. Has my child received antibiotics for whooping cough in the last 24 hours?
  5. Is my baby's weight at least 2.5 kg?
Answer every question to see your result.

What does participation involve?

If your child is eligible and you agree for them to take part, the study will involve collecting some information about their health. The research team will also take a deep swab from your child's nose and a blood sample. These samples will help us understand the whooping cough bacteria and your child's immune response. There are no study medications involved. The total duration of participation for each child will depend on their individual illness but generally involves these initial collections. There won't be multiple follow-up visits specifically for the study, beyond their standard medical care.

Potential risks and benefits

Taking part in this study may not offer direct personal benefits to your child, but the information we gather could help many other children in the future by improving our understanding of whooping cough and leading to better treatments or vaccines. There are some minor risks, mainly associated with the sample collection, such as temporary discomfort from the blood test or nose swab. You are free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (14)

  • CHU de Bordeaux
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • Hôpital Louis Mourier
    Verified postcode
    Colombes, France· Recruiting
  • Centre hospitalier intercommunal de Créteil
    Verified postcode
    Créteil, France· Not yet recruiting
  • Hôpital Roger Salengo
    Verified postcode
    Lille, France· Recruiting
  • Hospices Civils de Lyon
    Verified postcode
    Lyon, France· Recruiting
  • Hôpital de la Timone Enfants, APHM
    Verified postcode
    Marseille, France· Recruiting
  • Hôpital Nord, APHM
    Verified postcode
    Marseille, France· Recruiting
  • CHU de Nantes
    Verified postcode
    Nantes, France· Not yet recruiting
  • CHU Armand Trousseau
    Verified postcode
    Paris, France· Recruiting
  • Hopital Necker
    Verified postcode
    Paris, France· Recruiting
  • Hôpital Robert Debré
    Verified postcode
    Paris, France· Not yet recruiting
  • CHU Rouen
    Verified postcode
    Rouen, France· Not yet recruiting

Common questions

What is whooping cough?

Whooping cough, also known as pertussis, is a highly contagious disease that causes severe coughing fits, making it hard to breathe. It can be very serious, especially for babies.

Why is this study important?

This study is important because it aims to understand why whooping cough is becoming more common and severe, particularly in babies. This information could lead to better ways to prevent and treat the illness.

Will my child receive any new medication?

No, this study does not involve giving any new medications. It focuses on collecting information and samples to understand the disease better.

How long will my child be in the study?

Participation for your child will involve the initial collection of samples and health information. There won't be ongoing study visits beyond that.

Can I change my mind about my child participating?

Yes, you can withdraw your child from the study at any time, for any reason, and it will not affect their medical care.

How to find out more

Julie Toubiana, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Impact of Bacterial Expression and Immune Response in the Se…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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