Clinical, genetic, and immune causes of life-threatening bacterial infections in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will re-contact children included in the DIABACT IV cohort who were hospitalized in pediatric intensive care units in France between 2015 and 2018 for severe bacterial infections. Investigators will perform extended clinical phenotyping, immune workups, blood collection for whole-exome sequencing and PBMC biobanking, and collect family history and questionnaire data. Each family will be contacted individually to document other personal or familial episodes suggestive of immune defects. Data will be analyzed to identify clinical, genetic, and immunological factors that may predispose to severe bacterial disease in childhood.

Why it matters

Who can join: the full rules

Inclusion Criteria:

For patients:

* Patient included in the DIABACT IV study between 2015 and 2018, following hospitalization in a pediatric intensive care unit in France for a severe bacterial infection.
* Patient affiliated to a social security system
* Patient alive at the time of inclusion.
* Written consent from legal representatives for participation in research. If one of the legal representatives is unable to complete/sign the written consent, it will be sought orally by telephone and recorded in the patient's file. If the patient is over 18, written consent will be obtained. If the patient is a minor, consent will be sought with communication adapted to his/her level of understanding and age.

For parents:

* Patient's biological parents
* Written consent

Exclusion Criteria:

* Persons under court protection
* Refusal to participate in research

Where it's running

• Nantes University Hospital
  Nantes, Loire Atlantique, France Recruiting
• CHU de Brest
  Brest, France Not yet recruiting
• Hospices Civils de Lyon
  Lyon, France Not yet recruiting
• CHU Montpellier
  Montpellier, France Not yet recruiting
• Hôpital Armand Trousseau
  Paris, France Not yet recruiting
• Hôpital Necker enfants malades
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Elise LAUNAY
• Email: elise.launay@chu-nantes.fr
• Phone: 2 40 08 31 79

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.