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Recruiting Observational

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

NCT06775496 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-10-01
Last updated
2025-01-15

Condition(s) studied

Life-threatening Infection

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Obtained informed consent; * Otherwise healthy patient on admission Infectious episode: * life-threatening caused by known or unknown etiologic agent including viruses, bacteria, mycobacteria or mycetes (in case of lack of microbiologic isolate if clinical, laboratory, histopathologic and radiologic data, justify an infectious origin) * or caused by vaccine strains of attenuated vaccines such as Measles, Mumps, Rubella, Yellow Fever. * or caused by viruses, bacteria, mycobacteria or mycetes with features suggestive of congenital deficiency of immunity, the clinical pictures below refer to known conditions potentially associated with congenital errors of innate immunity Viral susceptibility: * ARDS caused by influenza virus type A, Sars-Cov2 * Life-threatening enterovirus rhomboencephalitis * Life-threatening infection by VZV, CMV, EBV, Rhinovirus, Respiratory Syncytial Virus * HSV encephalitis * Fulminant hepatitis from HAV * Kaposi\'s sarcoma from HHV8 * Beta-HPV infections such as: epidermodysplasia verruciformis, mucocutaneous carcinoma,recurrent/diffuse skin warts,, papillomatosis. Susceptibility to pyogenic bacteria: * At least one life-threatening infection or two episodes of invasive infectionsin otherwise healthy patients, either systemic (bacteremia) or focal (pneumonia, meningitis, arthritis, osteomyelitis, deep brain/peritoneal/hepatosplenic/muscle abscesses) * At least two episodes of disseminated or severe staphylococcal muco-cutaneous infections in otherwise healthy patients: decalvant folliculitis, pustules, furunculosis, blepharitis, lymphadenitis, abscesses Susceptibility to Tropherymawhipplei: \- Whipple\'s disease Susceptibility to Mycobacteria: * Life-threatening , recurrent, or persistent infections with tuberculous or nontuberculous mycobacteria in otherwise healthy patients * Post-vaccinal BCG-osis from attenuated M. Bovis strain Susceptibility to mycetes: * Chronic muco-cutaneous candidiasis Invasive fungal infections of sinuses, lungs, CNS, bones, joints, liver, spleen, and mucocutaneous membranes by Coccidioides, Paracoccidiodes, Cryptococcus, Histoplasma, Pneumocystis, Aspergillus, Talaromyces, Mucormycetes, or Blastomyces * Invasive candidiasis of brain, eyes, heart, bone, and blood in the absence of central catheters * Blood dissemination of fungal pathogens (except for candidiasis from central access) * Persistent positive fungal culture after adequate therapy in terms of drug susceptibility, dosage and duration * Deep infection with dermatophytes (Microsporum, Epidermophyton, Tricophyton) at dermal and lymph node level * Infection with rare yeasts (Geotrichum, Kodamaea, Malassezia/Rhodotorula, Saccharomyces, Trichosporon) or rare molds (AureobasidiumChrysosporium, Corynesprora, Exophiala, Geosmithia, Ochroconis, Paecilomyces, Phellinus, Phialophora, Rhizopus, Scopulariopsis) Other: -All infectious diseases not included in the list whose natural history differs from that expected for the identified pathogen with regard to severity, recurrence, and persistence of the disease, if the condition is not otherwise explainable by the patient\'s acquired risk factors. Exclusion Criteria: * Patients with nonimmunological diseases, secondary immunodeficiencies, nonpharmacological iatrogenic factors, immunosuppressive drug therapies

Primary outcome measure(s)

  • Identification and Prevalence of cases potentially associated with ECI — through study completion, an average of 1 year
    Identification and calculation of the prevalence of cases potentially associated with ECI (with or without genetic confirmation) among otherwise healthy patients admitted with severe or life-threatening infectious disease

Trial sites (6)

FacilityCityRegionStatus
IRCCS Istituto delle Scienze Neurologiche Bologna Bologna Recruiting
IRCCS Azienda Ospedaliero Universitaria di Bologna UO Pediatria Bologna Bologna Recruiting
IRCCS Azienda-Ospedaliero Universitaria di Bologna UO Anestesiologia e Rianimazione generale e pediatrica Bologna Bologna Recruiting
IRCCS Azienda-Ospedaliero Universitaria di Bologna UO Malattie Infettive Bologna Bologna Recruiting
IRCCS Azienda-Ospedaliero Universitaria di Bologna UO Neonatologia e terapia intensiva neonatale Bologna Bologna Recruiting
IRCCS Azienda-Ospedaliero Universitaria di Bologna UO Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve e Intensiva Bologna Bologna Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06775496 on ClinicalTrials.gov ↗ ← All trials in Italy