NCT06775496 Life-threatening Infection in Humans: from Epidemiological Analysis to Molecular Genetics
| NCT ID | NCT06775496 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Life-threatening Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2024-10-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Daniele Zama, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06775496 clinical trial?
This trial is open to participants of all sexes, studying Life-threatening Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06775496 currently recruiting?
Yes, NCT06775496 is actively recruiting participants. Contact the research team at daniele.zama2@unibo.it for enrollment information.
Where is the NCT06775496 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy, Bologna, Italy, Bologna, Italy and 2 additional locations.
Who is sponsoring the NCT06775496 clinical trial?
NCT06775496 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Daniele Zama, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 360 participants.