Biobank of Samples From Patients With Infectious Diseases (INFECTIOTEK)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infectious Diseases
• Intervention / Treatment: Other: Sampling

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, MD PhD; Phone Number: +33 142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Emma Rubenstein, MD; Phone Number: +33 142499066; Email: emma.rubenstein@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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...)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients diagnosed with an infectious disease

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 swab); Biopsy (a fragment of a lung, kidney or brain biopsy, if performed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performances of new biomarkers to identify infection	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Positive Likelihood Ratio, Negative Likelihood Ratio of the new biomarker	At diagnosis

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Biobank; Bacterial, viral and fungal diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: APHP240413

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No