Emerging Infectious Diseases and Their TreatmentsCOMETENCT07674550
Biological Collection on Emerging Infectious Diseases and Their Treatments
An observational study of Emerging Infectious Diseases and Their Treatments, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Unprecedented changes in human-environment interactions and increasing disruptions to ecosystems and the climate have contributed to the emergence of infectious diseases (Emerging Infectious Diseases, EIDs). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Emerging Infectious Diseases and Their Treatments
- How many people
- 5,300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2026to 14 Jun 2036
- How long will I take part?
- 10 Years
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with emerging infectious disease
Who may be able to join
- Patients aged 18 years or over
- Patients or individuals who have been exposed, are at risk of exposure, or are at risk of complications if exposed, or who are suspected of having, or are diagnosed with, an infectious disease considered to be emerging or at risk of emerging
- Patients receiving, or likely to receive, innovative treatments for the infection (new therapeutic molecules, checkpoint inhibitors, cell therapies, etc.)
- Patients or individuals receiving, or likely to receive, vaccines or other preventive therapeutic strategies
- Pregnant and breastfeeding women may be included.
Who cannot join
- Patients under a legal guardianship arrangement (guardianship, curatorship or court-ordered guardianship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital Toulouse
Toulouse, 31059
Guillaume MARTIN-BLONDEL, MD, PhD, +33561779699 ext. 33, martin-blondel.g@chu-toulouse.fr
Béatrice PIGNOLET, PhD, +33561779975 ext. 33, pignolet.b@chu-toulouse.fr
About this study
Official title: A Biological Sample Collection Established to Support Pathophysiological Research on Emerging and Potentially Emerging Infectious Diseases, as Well as Their Therapeutic Management.
Unprecedented changes in human-environment interactions and increasing disruptions to ecosystems and the climate have contributed to the emergence of infectious diseases (Emerging Infectious Diseases, EIDs). Advances in the treatment of cancers, malignant haematological disorders and immune-mediated inflammatory diseases are also contributing to the creation of new infectious risks among immunocompromised patient populations.
The COVID-19 pandemic has shown that structuring research prior to any outbreak is essential for the rapid implementation of responses to the emergence of an EID. The unpredictability of an EID's occurrence necessitates the planning of research projects in advance. A key element in this planning is the development of a collection of biological samples, providing a structured and immediately deployable resource for conducting pathophysiological and therapeutic research aimed at:
- Analyze the biological determinants of the microbe and the resulting infection
- Develop new tools for identification and characterization
- Study the factors (biomarkers/signatures) associated with individual patient susceptibility and response to treatment (personalized medicine)
- Understand the pathophysiology of infection to identify new targets for diagnostic, curative and preventive treatment
- Monitor the efficacy of curative and preventive treatments
Read the detailed description
COMETE consists in a prospective monocenter longitudinal non-interventional study allowing the collection of biological samples from individuals or patients investigated in the context of an emerging infectious disease or one at risk of emergence due to exposure or suggestive symptomatology, whether the infection is ultimately ruled out or confirmed, and whether or not they have received curative or preventive treatment for this infection.
Visits: The initial visit (inclusion) and follow-up visits will take place as part of the patient's routine care, assessing their disease status or the curative or preventive treatment received during either hospitalization or a consultation. During these visits, biological samples will be collected when sampling is planned as part of the care (for verification, suspicion, diagnosis, or monitoring), and then throughout the follow-up period as part of the care plan.
- Keywords
- Infectious diseases, acute respiratory infections, arboviral infections, infections of immunosuppressed patients, multi-resistant bacteria, orphan infectious diseases, disease X, new therapies
- Medical subject headings
- Communicable Diseases, Emerging, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects presenting with emerging or potentially emerging infectious diseases | Biological samples will be collected in the normal diagnosis and follow-up process (only blood will be collected in larger quantity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of biological samples and associated data from patients at risk of acquiring, or affected by, emerging or potentially emerging infectious diseases, including those receiving preventive or curative treatment for such infections
Prospective collection of all available biological and clinical-biological-imaging data collected during the usual clinical care
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
To improve our understanding of the pathophysiology of infection in order to identify new biomarkers for diagnostic and prognostic purposes, with a view to improving the management of emerging infectious diseases or those at risk of emerging
Identification of biomarkers using collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
Measured: through study completion, an average of 1 year
Identify new therapeutic targets for curative or preventive treatments
Identification of therapeutic targets using collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
Measured: through study completion, an average of 1 year
At the pathogen level: Analyse the biological determinants of the microbe and the resulting infection
Identification of biological determinants of the microbe and the resulting infection using collected biological samples with various methods of screening (PCR, qPCR, sequencing, metagenomics)
Measured: through study completion, an average of 1 year
At the pathogen level: Develop new tools for identification and characterisation
Use of the biological samples obtained from patients for using new and innovative methods of screening (PCR, qPCR, sequencing, metagenomics)
Measured: through study completion, an average of 1 year
At the host level: Identification and/or validation of associated or predictive biomarkers
Use of collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion14 Jun 2036 (estimated)
- Study completion14 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emerging Infectious Diseases and Their TreatmentsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 5,300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume MARTIN-BLONDEL, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674550
- Sponsor's protocol ID
- RC31/25/0195
- Acronym
- COMETE
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 29 Jun 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biological Sample Collection Established to Support Pathophysiological Research on Emerging and Potentially Emerging Infectious Diseases, as Well as Their Therapeutic Management.
- ClinicalTrials.gov ID
- NCT07674550
- Acronym / sponsor ID
- COMETE / RC31/25/0195
- Keywords
- Infectious diseases, acute respiratory infections, arboviral infections, infections of immunosuppressed patients, multi-resistant bacteria, orphan infectious diseases, disease X, new therapies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,300 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 14 Jun 2036 (estimated)
- Study completion
- 14 Jun 2036 (estimated)
- First posted
- 29 Jun 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.
Unprecedented changes in human-environment interactions and increasing disruptions to ecosystems and the climate have contributed to the emergence of infectious diseases (Emerging Infectious Diseases, EIDs). Advances in the treatment of cancers, malignant haematological disorders and immune-mediated inflammatory diseases are also contributing to the creation of new infectious risks among immunocompromised patient populations.
The COVID-19 pandemic has shown that structuring research prior to any outbreak is essential for the rapid implementation of responses to the emergence of an EID. The unpredictability of an EID's occurrence necessitates the planning of research projects in advance. A key element in this planning is the development of a collection of biological samples, providing a structured and immediately deployable resource for conducting pathophysiological and therapeutic research aimed at:
- Analyze the biological determinants of the microbe and the resulting infection
- Develop new tools for identification and characterization
- Study the factors (biomarkers/signatures) associated with individual patient susceptibility and response to treatment (personalized medicine)
- Understand the pathophysiology of infection to identify new targets for diagnostic, curative and preventive treatment
- Monitor the efficacy of curative and preventive treatments
Detailed description
COMETE consists in a prospective monocenter longitudinal non-interventional study allowing the collection of biological samples from individuals or patients investigated in the context of an emerging infectious disease or one at risk of emergence due to exposure or suggestive symptomatology, whether the infection is ultimately ruled out or confirmed, and whether or not they have received curative or preventive treatment for this infection.
Visits: The initial visit (inclusion) and follow-up visits will take place as part of the patient's routine care, assessing their disease status or the curative or preventive treatment received during either hospitalization or a consultation. During these visits, biological samples will be collected when sampling is planned as part of the care (for verification, suspicion, diagnosis, or monitoring), and then throughout the follow-up period as part of the care plan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects presenting with emerging or potentially emerging infectious diseases | – | –Biological samples will be collected in the normal diagnosis and follow-up process (only blood will be collected in larger quantity) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with emerging infectious disease
Key inclusion criteria (5 listed)
- Patients aged 18 years or over
- Patients or individuals who have been exposed, are at risk of exposure, or are at risk of complications if exposed, or who are suspected of having, or are diagnosed with, an infectious disease considered to be emerging or at risk of emerging
- Patients receiving, or likely to receive, innovative treatments for the infection (new therapeutic molecules, checkpoint inhibitors, cell therapies, etc.)
- Patients or individuals receiving, or likely to receive, vaccines or other preventive therapeutic strategies
- Pregnant and breastfeeding women may be included.
Key exclusion criteria (1 listed)
- Patients under a legal guardianship arrangement (guardianship, curatorship or court-ordered guardianship)
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
Collection of biological samples and associated data from patients at risk of acquiring, or affected by, emerging or potentially emerging infectious diseases, including those receiving preventive or curative treatment for such infections
Time frame: through study completion, an average of 1 year
Prospective collection of all available biological and clinical-biological-imaging data collected during the usual clinical care
5 secondary outcomes
To improve our understanding of the pathophysiology of infection in order to identify new biomarkers for diagnostic and prognostic purposes, with a view to improving the management of emerging infectious diseases or those at risk of emerging
Time frame: through study completion, an average of 1 year
Identify new therapeutic targets for curative or preventive treatments
Time frame: through study completion, an average of 1 year
At the pathogen level: Analyse the biological determinants of the microbe and the resulting infection
Time frame: through study completion, an average of 1 year
At the pathogen level: Develop new tools for identification and characterisation
Time frame: through study completion, an average of 1 year
At the host level: Identification and/or validation of associated or predictive biomarkers
Time frame: through study completion, an average of 1 year
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 29 Jun 2026.
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.
Guillaume MARTIN-BLONDEL, MD, PhD principal investigator
University Hospital, Toulouse
1 site 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 Their Treatments, run by University Hospital, Toulouse at 1 site 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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Guillaume MARTIN-BLONDEL, MD, PhD (+33561779699 ext. 33, martin-blondel.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of biological samples and associated data from patients at risk of acquiring, or affected by, emerging or potentially emerging infectious diseases, including those receiving preventive or curative treatment for such infections (time frame: through study completion, an average of 1 year). 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 29 Jun 2026.