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NCT Number: NCT06722131

Biobank of Samples From Patients With Infectious Diseases

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.

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Key information

Conditions

Infectious Diseases Bacterial Infections and Mycoses Communicable Diseases Disease Attributes Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

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)

Primary outcomes

Diagnostic performances of new biomarkers to identify infection

Time frame: At diagnosis

Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Positive Likelihood Ratio, Negative Likelihood Ratio of the new biomarker

Secondary outcomes

Description of pathophysiological phenomena

Time frame: Until 12 months

Resistance mechanisms, virulence parameters, immune responses to the infectious agent, susceptibility factors to infections
Description of prognostic biomarkers

Time frame: Until 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Rubenstein, MD

CONTACT

[email protected]

142499066 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

142499742 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: INFECTIOTEK

Important dates

Study start: 2025
Primary completion: 2031
Study completion: 2031
First posted: Dec 9, 2024
Registry last updated: Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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