NCT06775496

Life-threatening Infection in Humans: from Epidemiological Analysis to Molecular Genetics

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 360 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study, aims to identify and calculate the prevalence of cases potentially associated with congenital errors of immunity (ECI) among patients, hospitalized with infectious disease and carry out their clinical-laboratory characterization. Diagnoses of ECI are becoming increasingly common, by virtue of the continuing discoveries of new disease-causing genes and an increasing understanding of the clinical signs and symptoms of these entities. The most important challenge still remains to achieve early diagnosis, which is essential for appropriate and individualized treatment that also takes into account the prognostic and genetic counseling aspect related to these disorders, which are associated with high rates of morbidity and mortality. Patients with nonimmunological diseases, secondary immunodeficiencies, nonpharmacological iatrogenic factors, and immunosuppressive drug therapies will be involved in the study.

Detailed description

Severe, up to potentially fatal infections , represent a frequent cause of hospitalization in various clinical settings (pediatric and adult). Any infection of bacterial, viral, mycobacterial, or fungal etiology with a severe course, whether systemic (e.g., sepsis or septic shock, disseminated intravascular coagulation) or focal (e.g., pneumonia, meningitis, encephalitis skin infection) that causes organ damage and/or requires organ-specific or intensive supportive treatment (mechanical ventilation, inotropes, renal replacement treatment) should be considered life-threatening.

Conditions

• Life-threatening Infection

Timeline

• Start date: 2024-10-01
• Primary completion: 2030-12-31
• Completion: 2031-05-31
• First posted: 2025-01-15
• Last updated: 2025-01-15

Locations

6 sites across 1 country: Italy