Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions

Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - DiagRaMIE Biobanque

This multicenter prospective registry aims to establish a biobank of residual biological samples and associated clinical data from hospitalized patients. The registry will collect a wide range of specimens (serum, plasma, respiratory samples, urine, cerebrospinal fluid, biopsies) obtained during routine care, without any additional procedures. Data are pseudonymized and stored securely for up to 20 years. The biobank will be used to develop and evaluate rapid diagnostic tests (RDTs) for emerging infectious diseases and CBRN threats to improve epidemic preparedness and patient management.

Study Overview

• Status: Recruiting
• Conditions: Communicable Diseases; Zoonoses; Disease Outbreaks; Emerging Infectious Diseases; Biological Warfare Agents

Detailed Description

The DiagRaMIE Biobank is designed to support the national strategy for emerging infectious diseases and CBRN (Chemical, Biological, Radiological, Nuclear) threats. Over a 3-year inclusion period, residual samples from routine care (e.g., blood, plasma, urine, cerebrospinal fluid, respiratory specimens, biopsies) will be systematically collected from eligible hospitalized patients in Bicêtre and Paul Brousse hospitals. Associated demographic, clinical, and microbiological data will be recorded in a secure electronic case report form (eCRF) and pseudonymized.

No additional procedures, visits, or interventions are required for participants. The biobank will provide a sustainable source of high-quality biological material and standardized data to enable the development, validation, and rapid deployment of in vitro rapid diagnostic tests (RDTs) targeting pathogens of major public health concern, including those prioritized by WHO (e.g., Yersinia pestis, Candida auris, Francisella tularensis, MERS-CoV, Nipah virus, Crimean-Congo hemorrhagic fever virus). This initiative aims to strengthen epidemic surveillance and preparedness and to ensure timely diagnostic capacity in future public health crises.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Thierry NAAS,, PhD; Phone Number: +33 1 45 21 29 86; Email: thierry.naas@aphp.fr
• Study Contact Backup: Name: Saoussen OUESLATI, PhD; Phone Number: +33 1 45 21 29 86; Email: saoussen.oueslati@aphp.fr

Study Locations

• France
  • Le Kremlin-Bicêtre, France
    • Recruiting
    • CHU Bicêtre
    • Contact: Christophe PENNA, MD PhD; Phone Number: +33 145213474; Email: christophe.penna@aphp.fr
  • Villejuif, France
    • Recruiting
    • CHU Paul Brousse
    • Contact: Audrey COILLY, MD PhD; Phone Number: +33 145596636; Email: audrey.coilly@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in one of the participating study centers

Description

Inclusion Criteria:

• Adults (≥ 18 years old) hospitalized in one of the participating centers at Bicêtre or Paul Brousse hospitals, for whom residual biological samples are available as part of routine care in one or more participating hospital departments.
• Covered by, or entitled to, the French social security system (excluding State Medical Aid - AME).
• Patient or legal representative/trusted person informed about the registry and having provided written consent to participate.

Exclusion Criteria:

• Patients under judicial protection (guardianship or curatorship).
• Patients deprived of liberty by judicial or administrative decision.
• Patients not speaking French and not accompanied by a translator.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of residual clinical samples successfully collected, aliquoted, and stored with associated clinical and microbiological data	Creation of a collection of residual biological samples (serum, plasma, urine, respiratory samples, CSF, biopsies, etc.) and associated clinical and microbiological data obtained during routine care	36months (end of patient inclusion period)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Commissariat A L'energie Atomique; NG Biotech

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cerebrospinal fluid; Urine samples; Blood and blood derivatives: whole blood, serum, plasma, cord blood; Microbiological specimens: positive blood cultures; Respiratory samples; expectorations; bronchoalveolar lavage (BAL); protected distal samples; bronchial aspirations; Stool or rectal swabs; Skin or mucosal swabs; Biopsies and puncture material: lymph node, hepatic, gastric, or other tissue samples when available
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Pathological Conditions, Signs and Symptoms; Animal Diseases; Communicable Diseases; Communicable Diseases, Emerging; Zoonoses
• Other Study ID Numbers: APHP 230322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No