Biobank of Samples From Patients With Infectious Diseases

Not yet recruiting

• Conditions: Infectious Diseases

• Registration Number: NCT06722131
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-01-01
• Primary Completion: 2031-01-01
• Study Completion: 2031-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performances of new biomarkers to identify infection	At diagnosis	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Positive Likelihood Ratio, Negative Likelihood Ratio of the new biomarker

Secondary Outcome Measures

Name	Time	Method
Description of pathophysiological phenomena	Until 12 months	Resistance mechanisms, virulence parameters, immune responses to the infectious agent, susceptibility factors to infections
Description of prognostic biomarkers	Until 12 months