Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test (B-RAPID)
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance markers directly from whole blood in patients with suspected bloodstream infection or sepsis.
Participants enrolled in the study will have blood collected at the same time as blood samples obtained for standard-of-care blood culture testing. Study blood samples will be tested using the UllCORE BSI Test either as fresh samples or after frozen storage, according to the study protocol.
The results of the UllCORE BSI Test will be compared with standard-of-care microbiology results and, when applicable, additional testing methods to assess the diagnostic performance of the investigational test.
The UllCORE BSI Test results will not be used to guide patient care and will not be provided to treating healthcare professionals for clinical decision-making. Participation in the study will therefore not change the standard medical care received by participants.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Roger Canton
- 전화번호: +34 936553530
- 이메일: rcanton@deepull.com
연구 장소
-
-
-
Berlin-Zehlendorf, 독일, 12203
- 아직 모집하지 않음
- Charité - Campus Benjamin Franklin
-
Jena, 독일, 07443
- 아직 모집하지 않음
- Universitaetsklinikum Jena
-
Leipzig, 독일, 04103
- 아직 모집하지 않음
- Universitaetsklinikum Leipzig
-
-
-
-
California
-
Orange, California, 미국, 92868
- 아직 모집하지 않음
- University of California at Irvine Medical Center
-
-
Florida
-
Tampa, Florida, 미국, 33606
- 아직 모집하지 않음
- Tampa General Hospital
-
-
Maryland
-
Baltimore, Maryland, 미국, 21287
- 아직 모집하지 않음
- The Johns Hopkins Hospital
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- 아직 모집하지 않음
- Beth Israel Deaconess Medical Center
-
-
Michigan
-
Novi, Michigan, 미국, 48374
- 아직 모집하지 않음
- Henry Ford Health
-
-
Missouri
-
St Louis, Missouri, 미국, 63110
- 아직 모집하지 않음
- Washington University School of Medicine
-
-
Ohio
-
Cleveland, Ohio, 미국, 44106
- 모병
- University Hospitals Cleveland Medical Center
-
-
Pennsylvania
-
Danville, Pennsylvania, 미국, 17822
- 아직 모집하지 않음
- Geisinger Health
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37232
- 아직 모집하지 않음
- Vanderbilt health
-
-
Texas
-
Temple, Texas, 미국, 76508
- 아직 모집하지 않음
- Baylor Scott & White Health Medical Center-Temple
-
-
-
-
-
Badalona, 스페인
- 아직 모집하지 않음
- Hospital Germans Trias I Pujol
-
Barcelona, 스페인, 08036
- 아직 모집하지 않음
- Hospital Clínic de Barcelona
-
Barcelona, 스페인, 08035
- 아직 모집하지 않음
- Hospital Universitari Vall d'Hebron - VHIO
-
-
-
-
-
Florence, 이탈리아, 50134
- 아직 모집하지 않음
- Azienda Ospedaliera Universitaria Careggi
-
Perugia, 이탈리아, 06129
- 아직 모집하지 않음
- Ospedale di Perugia Santa Maria della Misericordia
-
-
-
-
-
Limoges, 프랑스, 87000
- 아직 모집하지 않음
- CHU de Limoges - Hôpital Dupuytren
-
Lyon, 프랑스, 69004
- 아직 모집하지 않음
- Hôpital de la Croix-Rousse - HCL
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The study population will consist of patients with suspected bloodstream infection (BSI) or sepsis who are undergoing standard-of-care blood culture testing. Participants will be recruited from Emergency Departments and Intensive Care Units.
Eligible patients will be identified based on clinical signs and symptoms consistent with suspected BSI or sepsis, such as fever, elevated inflammatory markers, hypotension, or other clinical findings prompting blood culture collection. Participants meeting the eligibility criteria will be enrolled prospectively and consecutively, without preference for specific demographic or clinical characteristics.
설명
Inclusion Criteria:
- Any age (where the remaining criteria can be safely fulfilled)
- Ability to provide consent/assent in accordance with Institutional Review Board (IRB)/Ethics Committee (EC) determinations
- The patient is presenting with signs and symptoms of suspected bloodstream infection (BSI) or fulfils the criteria for the hospital sepsis protocol.
Planned blood culture collection and laboratory analysis as per standard of care (SOC).
• Patient is able and an appropriate candidate to be able to collect 2 K2 ethylenediaminetetraacetic acid (EDTA) tubes of whole blood.
Exclusion Criteria:
- Unable to collect UllCORE BSI Test samples from the same venipuncture as blood culture (BC) samples
- Patient was previously enrolled in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Participants with Suspected Bloodstream Infection or Sepsis
Participants with suspected bloodstream infection or sepsis whose prospectively collected whole-blood specimens are either tested fresh using the investigational UllCORE Bloodstream Infection (BSI) Test or stored frozen before subsequent testing. UllCORE BSI Test results will be compared with standard-of-care microbiology results and will not be used for clinical decision-making. |
The UllCORE Bloodstream Infection (BSI) Test is an investigational molecular diagnostic test designed to detect microorganisms and selected antimicrobial resistance markers directly from whole blood. In this study, prospectively collected whole blood specimens will be tested either fresh or after frozen storage, according to the study protocol. UllCORE BSI Test results will be compared with standard-of-care microbiology results and will not be used for clinical decision-making. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
기간: From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.
|
Clinical performance of the UllCORE Bloodstream Infection (BSI) Test will be assessed using positive percent agreement (PPA) and negative percent agreement (NPA) compared with standard-of-care microbiological methods, as applicable. Performance will be evaluated for the microorganisms and antimicrobial resistance markers included in the test panel. |
From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- PE-REC-2508
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. .