Identifying life-threatening infections linked to immune system errors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify and calculate the prevalence of cases associated with congenital errors of immunity (ECI) among patients hospitalized with severe infections. It focuses on the clinical and laboratory characterization of these patients, who may present with life-threatening infections caused by various pathogens. The study seeks to improve early diagnosis and individualized treatment, which is crucial for managing these high-morbidity and high-mortality conditions. Patients with both immunological and non-immunological diseases will be included to better understand the spectrum of life-threatening infections.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Daniele Zama, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Daniele Zama, MD
• Email: daniele.zama2@unibo.it
• Phone: 0512144688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.