Menu
Not yet recruiting NCT06722131

Biobank of Samples From Patients With Infectious Diseases

Observational Infectious Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sampling.
Who it may be relevant to
Registry conditions: Infectious Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Création d'Une biothèque de prélèvements de Patients présentant Une Pathologie Infectieuse

Overview

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.

Interventions

  • Other Sampling
    Additional biological sampling at the same time as routine-care samples taken in the context of the diagnosis of the infectious disease and if planned at one and 12 months of follow-up * The considered samples are as follows : * Blood sample tubes (5 x 5 mL tubes, i.e. 25 mL) * Infection site sample if applicable : * Urine (10 mL) * Stool (1 mL) * CSF (1 mL) * Sputum (1 mL) or bronchoalveolar lavage fluid (10 mL) * Nasopharyngeal swab (one swab) * Genital swab (one swab) * Skin swab (one s

Primary outcome measures

  • Diagnostic performances of new biomarkers to identify infection [Time frame: At diagnosis]
Secondary outcome measures (2)
  • Description of pathophysiological phenomena [Time frame: Until 12 months]
  • Description of prognostic biomarkers [Time frame: Until 12 months]

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...)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06722131 · APHP240413

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗