Biobank of Samples From Patients With Infectious Diseases

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient over 18 years of age

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)

Disqualifiers

Refusal to participate

Inability to give consent (cognitive impairment etc...)

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sampling

    Other intervention

    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)

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Patients diagnosed with an infectious disease1 intervention

Trial outcomes

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

Time frame
At diagnosis

Secondary outcomes

1

Description of pathophysiological phenomena

Resistance mechanisms, virulence parameters, immune responses to the infectious agent, susceptibility factors to infections

Time frame
Until 12 months
2

Description of prognostic biomarkers

Time frame
Until 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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