Clinical trial NCT06722131: Biobank of Samples From Patients With Infectious Diseases
Official title: Création d'Une biothèque de prélèvements de Patients présentant Une Pathologie Infectieuse
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infectious Diseases
Keywords: Biobank
Bacterial, viral and fungal diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the Infectious Diseases Departments of Saint-Louis and Lariboisière Hospitals, with a diagnosis of infectious disease, and who have biological samples in the context of their routine medical care

Brief summary: The aim of the INFECTIOTEK biobank will be to prospectively build a biobank of multiple biological samples from patients with infectious diseases in order to identify diagnostic and prognostic biomarkers, genetic susceptibility factors and immune response mechanisms in such diseases.

The population of the study will consist of patients treated in the Infectious Diseases Departments of Saint-Louis and Lariboisière Hospitals, with a diagnosis of infectious disease, and who have biological samples in the context of their routine medical care.

The diseases studied in this research project are bacterial infections (urinary tract infections, neurologic infections, sexually transmitted infections, pulmonary infections), viral infections (HIV, hepatitis, respiratory viruses, viruses affecting immunocompromised patients) and fungal infections (Aspergillus, Mucorales, Cryptococcus). These diseases are the domains of expertise and research of the clinical and biological teams at the Saint-Louis and Lariboisière hospitals.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Diagnosed with one of the following infectious diseases :

  * Infection with HIV-1 or HIV-2, or person at risk of infection with HIV
  * Viral hepatitis (HAV, HBV, HCV, HDV, HEV)
  * Pulmonary infections: bacterial (notably Nocardia), viral (Influenza, RSV, SARS-CoV-2, Adenovirus), fungal (Aspergillus, Mucorales)
  * Urinary tract infections
  * Sexually transmitted infections (Neisseria gonorrheae, Chlamydia trachomatis, Mycoplasma genitalium, Treponema pallidum)
  * Neuromeningeal infections: (Neisseria meningitidis, Streptococcus pneumoniae), viral (HSV, VZV), fungal (Cryptococcus).
  * Infections affecting immunocompromised patients: herpes viruses (HSV, VZV, CMV, EBV), polyomavirus BK
  * Emerging pathogen X (in the event of an epidemic)
  * Signature of research consent form
  * Health coverage with social security system or state medical aid

Exclusion Criteria:

* Refusal to participate
* Inability to give consent (cognitive impairment etc...)

Primary outcomes:
measure: Diagnostic performances of new biomarkers to identify infection
timeFrame: At diagnosis
Secondary outcomes:
measure: Description of pathophysiological phenomena
timeFrame: Until 12 months
measure: Description of prognostic biomarkers
timeFrame: Until 12 months
Other outcomes:
Locations:
Study officials:
References: