Emerging Infectious DiseasesNCT07411729
Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions
An observational study of Emerging Infectious Diseases and Communicable Diseases, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emerging Infectious Diseases, Communicable Diseases, Biological Warfare Agents
- How many people
- 800 participants
- Where
- 10 sitesFrance
- Study dates
- 3 Jun 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in one of the participating study centers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Tai PHAM, MD PhD, 145217244 ext. +33, tai.pham@aphp.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Samy FIGUEIREDO, MD PhD, 145213441 ext. +33, samy.figueiredo@aphp.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Lélia ESCAUT, PhD, 145217421 ext. +33, lelia.escaut@aphp.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Nicolas NOEL, MD PhD, 145217934 ext. +33, nicolas.noel@aphp.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Renaud SNANOUDJ, MD PhD, 145212116 ext. +33, renaud.snanoudj@aphp.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Dominique LUTON, MD PhD, 145217701 ext. +33, dominique.luton@aphp.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Cédric LEBACLE, PhD, 145213694 ext. +33, cedric.lebacle@aphp.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Gaëtane NOCTURNE, MD PhD, 145212416 ext. +33, gaetane.nocturne@aphp.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Christophe PENNA, MD PhD, 145213474 ext. +33, christophe.penna@aphp.fr
- Recruiting
CHU Paul Brousse
Villejuif
Audrey COILLY, MD PhD, 145596636 ext. +33, audrey.coilly@aphp.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Emerging Infectious Diseases, Communicable Diseases, Biological Warfare Agents, Zoonoses, Disease Outbreaks
- Keywords
- Blood and blood derivatives: whole blood, serum, plasma, cord blood, Microbiological specimens: positive blood cultures, Urine samples, Respiratory samples, expectorations, bronchoalveolar lavage (BAL), protected distal samples, bronchial aspirations, Cerebrospinal fluid, Stool or rectal swabs, Skin or mucosal swabs, Biopsies and puncture material: lymph node, hepatic, gastric, or other tissue samples when available
- Medical subject headings
- Communicable Diseases, Emerging, Communicable Diseases, Zoonoses
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36months (end of patient inclusion period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start3 Jun 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emerging Infectious DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- NG Biotech, Commissariat A L'energie Atomique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411729
- Sponsor's protocol ID
- APHP 230322
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - DiagRaMIE Biobanque
- ClinicalTrials.gov ID
- NCT07411729
- Acronym / sponsor ID
- APHP 230322
- Conditions
- Emerging Infectious Diseases, Communicable Diseases, Biological Warfare Agents, Zoonoses, Disease Outbreaks
- Keywords
- Blood and blood derivatives: whole blood, serum, plasma, cord blood, Microbiological specimens: positive blood cultures, Urine samples, Respiratory samples, expectorations, bronchoalveolar lavage (BAL), protected distal samples, bronchial aspirations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- NG Biotech, Commissariat A L'energie Atomique
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in one of the participating study centers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of residual clinical samples successfully collected, aliquoted, and stored with associated clinical and microbiological data
Time frame: 36months (end of patient inclusion period)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emerging Infectious Diseases and Communicable Diseases, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry NAAS,, PhD (1 45 21 29 86 ext. +33, thierry.naas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of residual clinical samples successfully collected, aliquoted, and stored with associated clinical and microbiological data (time frame: 36months (end of patient inclusion period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.