Performance of Clinical Metagenomics in Stool and Urine Samples for Unexplained Diseases Diagnostic and Emerging Diseases Surveillance in Immunocompromised Patients (SENTINEL)
연구 개요
상태
개입 / 치료
상세 설명
Emerging and re-emerging infectious diseases require broad-spectrum diagnostic approaches capable of identifying a wide range of microorganisms without prior assumptions. This challenge is particularly relevant in immunocompromised patients, who are at high risk for opportunistic, atypical, or previously unknown infections. Conventional microbiological methods rely on targeted assays and may fail to detect uncommon or novel pathogens.
Clinical metagenomics based on high-throughput sequencing (metagenomic Next-Generation Sequencing, mNGS) enables unbiased detection of viral, bacterial, fungal, and parasitic genomes directly from clinical samples. At Necker-Enfants Malades Hospital (Paris, France), implementation of a diagnostic mNGS platform between 2019 and 2022 demonstrated a higher diagnostic yield in immunocompromised patients compared with immunocompetent individuals, with particularly high positivity rates in stool samples. These findings support the evaluation of non-invasive samples as complementary diagnostic matrices.
The SENTINEL study aims to assess the diagnostic performance of mNGS performed on non-invasive samples (stool and urine) compared with invasive reference samples (blood, cerebrospinal fluid, bronchoalveolar lavage fluid, or tissue) in immunocompromised pediatric and adult patients with suspected infection. The underlying hypothesis is that adding stool and/or urine mNGS to invasive sample analysis will increase the detection rate of causative or possibly causative pathogens.
In this multicenter study, invasive samples collected as part of standard of care and study-specific stool and urine samples will undergo centralized mNGS analysis. Non-invasive samples will be collected preferably on the same day as the reference sample or within a maximum of five days.
Clinical and laboratory data generated during routine care will be collected at inclusion. Participants will be followed for three months to evaluate the clinical impact of mNGS findings. For pathogens classified as possibly causative, confirmatory analyses will be performed to support causal attribution.
Secondary analyses will examine the detection of emergent or re-emergent pathogens, including previously unknown pathogens, as well as diagnostic performance according to clinical presentation and type of immune deficiency. The impact of non-invasive mNGS results on patient management and the incremental laboratory cost associated with adding stool and urine analyses will also be evaluated.
The study is sponsored by Assistance Publique - Hôpitaux de Paris and funded by the French Ministry of Health and ANRS Emerging Infectious Diseases.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Aminata TRAORE, Project advisor
- 전화번호: +33 01 42 19 27 34
- 이메일: aminata.traore6@aphp.fr
연구 연락처 백업
- 이름: Jacques FOURGEAUD, PharmD, PhD
- 전화번호: +33 01 44 49 56 11
- 이메일: jacques.fourgeaud@aphp.fr
연구 장소
-
-
Île-de-France Region
-
Paris, Île-de-France Region, 프랑스, 75015
- Hopital Necker - Enfants Malades
-
연락하다:
- Aminata TRAORE, Project advisor
- 전화번호: +33 01 42 19 27 34
- 이메일: aminata.traore6@aphp.fr
-
연락하다:
- Jacques FOURGEAUD, PharmD, PhD
- 전화번호: +33 01 44 49 56 11
- 이메일: jacques.fourgeaud@aphp.fr
-
수석 연구원:
- Jacques FOURGEAUD, PharmD, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Pediatric or adult patient with a primary or secondary immune deficiency (including immunosuppressive therapy, chemotherapy, HIV infection).
- mNGS prescription on tissue, CSF, BAL and/or blood to identify the causative pathogen in patient with symptoms or biological signs compatible with an infection as per investigator's judgment (e.g., fever, leukocytosis, increased CRP level)
- Non opposition of the participant (or parent(s)/ legal guardian(s) of infant participant)
Exclusion Criteria:
- No healthcare insurance
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Pediatric or adult patient with a primary or secondary immune deficiency
Pediatric or adult populations with a primary or secondary immune deficiency following immunosuppressive treatment or an underlying disease are at increased risk of severe infection by a wide range of viruses.
|
The intervention aims to increase pathogen detection of mNGS with the addition of non-invasive samples compared with invasive sampling alone
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Detection of a "causative" or "possibly causative" pathogens by mNGS in Non-Invasive (stool and/or urine) and invasive samples (blood, CSF, BAL and/or tissue)
기간: 14 days
|
|
14 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Detection of emergent or re-emergent pathogens by mNGS in non-invasive samples (stool and/or urine) and invasive sample (blood and/or CSF and/or BAL and/or tissue)
기간: 14 days
|
Among detected "causative" or "possibly causative" pathogen", evaluation of emergent or re-emergent pathogen:
|
14 days
|
|
Changes in patient management
기간: 3 months
|
Evaluation of the impact of stool and urine mNGS results on patient management: administration of antimicrobial therapy and/or specific or polyvalent immunoglobulins, change in the management of immunosuppression (reduction of immunosuppressive therapy, delay of solid organ or haematopoietic stem cell transplantation), hospitalization (incidence, duration) and/or additional samples collection
|
3 months
|
|
Detection of the "possibly causative" pathogen genomes by specific PCR in all available invasive and non-invasive samples collected at inclusion and by in situ hybridization in available tissue sample collected at inclusion
기간: 14 days
|
Confirmation of the role of the detected "possibly causative" pathogen in the patient's symptoms using additional investigations.
|
14 days
|
|
Detection of "causative" or "possibly causative" Pathogens by mNGS in Non-Invasive Samples in different subgroups
기간: 14 days
|
Subgroups according to symptoms, immune deficiency type and age
|
14 days
|
|
Cost of performing mNGS in invasive, stool and urine samples
기간: 14 days
|
Calculation of the cost (including laboratory personnel and reagents) of performing mNGS in invasive, stool and urine samples
|
14 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jacques FOURGEAUD, PharmD, PhD, Assistance Publique - Hôpitaux de Paris
- 연구 의자: Pierre FRANGE, MD, PhD, Assistance Publique - Hôpitaux de Paris
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- APHP241015
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .