Biological Collection on Emerging Infectious Diseases and Their Treatments (COMETE)

June 24, 2026 updated by: University Hospital, Toulouse

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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

5300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with emerging infectious disease

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- Patients under a legal guardianship arrangement (guardianship, curatorship or court-ordered guardianship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Identification of biomarkers using collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
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
Identification of therapeutic targets using collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
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
Identification of biological determinants of the microbe and the resulting infection using collected biological samples with various methods of screening (PCR, qPCR, sequencing, metagenomics)
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
Use of the biological samples obtained from patients for using new and innovative methods of screening (PCR, qPCR, sequencing, metagenomics)
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
Use of collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Guillaume MARTIN-BLONDEL, MD, PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

June 14, 2036

Study Completion (Estimated)

June 14, 2036

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/25/0195

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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