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Biobank of Samples From Patients With Infectious Diseases

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06722131
Acronym
INFECTIOTEK
Enrollment
1000
Registered
2024-12-09
Start date
2025-01-01
Completion date
2031-01-01
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Diseases

Keywords

Biobank, Bacterial, viral and fungal diseases

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.

Interventions

OTHERSampling

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)

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performances of new biomarkers to identify infectionAt diagnosisSensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Positive Likelihood Ratio, Negative Likelihood Ratio of the new biomarker

Secondary

MeasureTime frameDescription
Description of pathophysiological phenomenaUntil 12 monthsResistance mechanisms, virulence parameters, immune responses to the infectious agent, susceptibility factors to infections
Description of prognostic biomarkersUntil 12 months

Contacts

Primary ContactEmma Rubenstein, MD
emma.rubenstein@aphp.fr142499066
Backup ContactJérôme Lambert, MD PhD
jerome.lambert@u-paris.fr142499742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026