Actively Recruiting

All Genders
NCT06775496

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-15

360

Participants Needed

6

Research Sites

347 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Obtained informed consent
  • Patient is otherwise healthy on admission
  • Infectious episode is life-threatening and caused by known or unknown viruses, bacteria, mycobacteria, or fungi
  • Infectious episode can be caused by vaccine strains such as Measles, Mumps, Rubella, or Yellow Fever vaccines
  • Infection caused by agents with features suggesting congenital immunity deficiency
  • Viral susceptibility including ARDS from influenza A or SARS-CoV-2, severe enterovirus rhomboencephalitis, life-threatening infections from VZV, CMV, EBV, Rhinovirus, RSV, HSV encephalitis, fulminant hepatitis from HAV, Kaposi's sarcoma from HHV8, beta-HPV infections
  • Susceptibility to pyogenic bacteria with at least one life-threatening or two invasive infections in otherwise healthy patients
  • At least two episodes of severe staphylococcal mucocutaneous infections
  • Susceptibility to Tropheryma whipplei (Whipple's disease)
  • Life-threatening, recurrent, or persistent mycobacterial infections including post-vaccinal BCG-osis
  • Chronic mucocutaneous candidiasis and invasive fungal infections affecting various organs
  • Deep infections with dermatophytes or infections with rare yeasts or molds
  • Infectious diseases with unusual severity, recurrence, or persistence not explained by acquired risk factors
Not Eligible

You will not qualify if you...

  • Patients with nonimmunological diseases
  • Patients with secondary immunodeficiencies
  • Patients with nonpharmacological iatrogenic factors
  • Patients receiving immunosuppressive drug therapies

AI-Screening

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Trial Site Locations

Total: 6 locations

1

IRCCS Istituto delle Scienze Neurologiche

Bologna, Bologna, Italy, 40124

Actively Recruiting

2

IRCCS Azienda Ospedaliero Universitaria di Bologna UO Pediatria

Bologna, Bologna, Italy, 40138

Actively Recruiting

3

IRCCS Azienda-Ospedaliero Universitaria di Bologna UO Anestesiologia e Rianimazione generale e pediatrica

Bologna, Bologna, Italy, 40138

Actively Recruiting

4

IRCCS Azienda-Ospedaliero Universitaria di Bologna UO Malattie Infettive

Bologna, Bologna, Italy, 40138

Actively Recruiting

5

IRCCS Azienda-Ospedaliero Universitaria di Bologna UO Neonatologia e terapia intensiva neonatale

Bologna, Bologna, Italy, 40138

Actively Recruiting

6

IRCCS Azienda-Ospedaliero Universitaria di Bologna UO Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve e Intensiva

Bologna, Bologna, Italy, 40138

Actively Recruiting

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Research Team

D

Daniele Zama, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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