Biobank of Samples From Patients With Infectious Diseases

NCT ID: NCT06722131

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2031-01-01

Brief Summary

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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

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Conditions

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Infectious Diseases

Keywords

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Biobank Bacterial, viral and fungal diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients diagnosed with an infectious disease

Sampling

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Emma Rubenstein, MD

Role: CONTACT

Phone: 142499066

Email: [email protected]

Jérôme Lambert, MD PhD

Role: CONTACT

Phone: 142499742

Email: [email protected]

Other Identifiers

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APHP240413

Identifier Type: -

Identifier Source: org_study_id