Screening for immune deficiencies in children with severe infections in the ICU

Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

This study is testing whether children under 16 with severe infections in the ICU have hidden immune deficiencies that could affect their treatment and recovery.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 3 Months to 16 Years
• Sex: All
• Sponsor: University Hospital, Montpellier (other)
• Locations: 1 site (Montpellier)
• Trial ID: NCT04990908 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the incidence of primary immune deficiencies in pediatric patients admitted to the intensive care unit with severe infections. It challenges the traditional diagnostic approach by exploring the potential genetic susceptibility underlying severe infections, regardless of their cause. The study will include children under 16 years old who have documented severe infections requiring hospitalization for more than 24 hours. By systematically screening these patients, the researchers hope to uncover previously undiagnosed immune deficiencies that could impact treatment and outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are children under 16 years old with documented severe infections requiring intensive care.

Not a fit: Patients with documented severe infections that do not require intensive care or have previous comorbidities explaining their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and targeted treatment for children with undetected immune deficiencies, improving their health outcomes.

How similar studies have performed: While the approach of screening for immune deficiencies in severe infections is gaining interest, this specific study represents a novel investigation into the incidence of such conditions in pediatric patients.

Eligibility criteria

Inclusion criteria:

* Inclusion age less than 16 years
* Inclusion age \> 3 months of actual age for term infants and \> 3 months for former preterm infants.
* Documented severe infection (bacterial, viral, fungal) at the University Hospital Center of Montpellier, Toulouse or Marseille
* Severe infections concerned by the study: any infection requiring hospitalization in pediatric intensive care (more than 24 hours) including:
* meninges or brain lesions, pleuro-pneumopathy, any infection associated with sepsis and/or an opportunistic germ, septic shock, etc.
* Encephalitis and encephalomyelitis of infectious origin
* Child benefiting from a social security system
* Collection of parental/legal representative consent

Exclusion criteria:

* Undocumented severe infections
* Acute bronchiolitis
* Children admitted with isolated SRV bronchiolitis without further complications from the infection;
* Previous comorbidity explaining the infection and/or stay in ICU/Continuing Care: Primary or known secondary immune deficiency; burns; risk factors for non-infectious epilepsy (encephalopathy, known epilepsy, head trauma), pneumonia caused by swallowing disorders or tracheotomy or chronic lung disease, asthma, meningitis favored by cochlear implants, breach of blood-brain barrier or neuromeningetic material, deep infection on implanted material or within 48h after surgery, cardiovascular decompensation; any other chronic conditions that may contribute to infection;
* Inability to obtain consent from parents/legal guardians.

Where this trial is running

Montpellier

• Uhmontpellier — Montpellier, France (RECRUITING)

Study contacts

• Study coordinator: Eric JEZIORSKI

Conditions: Severe Infection, Severe Immune Deficiency, genetics, screening