Biobank of Samples From Patients With Infectious Diseases

NCT06722131 | Not Yet Recruiting

• 1 other identifier: APHP240413
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infectious Diseases

Keywords

Biobank; Bacterial, viral and fungal diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Description of pathophysiological phenomena

  Until 12 months

• Description of prognostic biomarkers

  Until 12 months

Study Arms (1)

Patients diagnosed with an infectious disease

Other: Sampling

Interventions

Sampling OTHER

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)

Patients diagnosed with an infectious disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling In addition, infection site sampling according to pathology : * Urine * Stool * cerebrospinal fluid * Sputum or bronchoalveolar lavage liquid * Nasopharyngeal swab * Genital swab * Skin swab * Biopsy (a fragment of a lung, kidney or brain biopsy if performed)

MeSH Terms

Conditions

Communicable Diseases; Mycoses

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Central Study Contacts

Emma Rubenstein, MD

CONTACT

142499066; emma.rubenstein@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: December 9, 2024

Record last verified: 2024-11