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NCT Number: NCT07674550

Biological Collection on Emerging Infectious Diseases and Their Treatments

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

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Key information

Conditions

Emerging Infectious Diseases and Their Treatments Communicable Diseases Communicable Diseases, Emerging Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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, …)

  2. 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, …)

  3. 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)

  4. 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)

  5. 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, …)

Study contacts

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

Béatrice PIGNOLET, PhD

CONTACT

[email protected]

+33561779975 ext. 33

Guillaume MARTIN-BLONDEL, MD, PhD

CONTACT

[email protected]

+33561779699 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

A Biological Sample Collection Established to Support Pathophysiological Research on Emerging and Potentially Emerging Infectious Diseases, as Well as Their Therapeutic Management.

Acronym: COMETE

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

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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