Biological Collection on Emerging Infectious Diseases and Their Treatments (COMETE)
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Guillaume MARTIN-BLONDEL, MD, PhD
- 전화번호: 33 +33561779699
- 이메일: martin-blondel.g@chu-toulouse.fr
연구 연락처 백업
- 이름: Béatrice PIGNOLET, PhD
- 전화번호: 33 +33561779975
- 이메일: pignolet.b@chu-toulouse.fr
연구 장소
-
-
-
Toulouse, 프랑스, 31059
- University Hospital toulouse
-
연락하다:
- Guillaume MARTIN-BLONDEL, MD, PhD
- 전화번호: 33 +33561779699
- 이메일: martin-blondel.g@chu-toulouse.fr
-
연락하다:
- Béatrice PIGNOLET, PhD
- 전화번호: 33 +33561779975
- 이메일: pignolet.b@chu-toulouse.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Guillaume MARTIN-BLONDEL, MD, PhD, University Hospital, Toulouse
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- RC31/25/0195
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .