A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP)
A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP Study)
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Paddington, 영국, W2 1PG
- Ajit Lalvani
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adults aged 18 or over
- Admitted to a participating severe respiratory failure centre or ICU
- Admitted due to community acquired pneumonia (CAP) according to clinical and radiological criteria
- Tracheal intubation, receiving mechanical ventilation +/- ECMO
- Requires bronchoscopy as part of routine diagnostic care plan
- Bronchoscopy takes place within 72 hours of first admission to hospital
Exclusion Criteria:
- Any current or previous condition/circumstance that, in the opinion of the investigator or study nurse, may put the individual at risk if participating
- Patients receiving end of life care
- Hospitalisation within the previous 28 days (not including pre-ECMO hospitalisation for ECMO patients)
- Consent or assent not given
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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SCAP requiring ECMO
Patients diagnosed with severe respiratory failure due to community acquired pneumonia that require extra-corporeal membrane oxygenation and a routine bronchoscopy for clinical purposes. Molecular laboratory techniques will be applied to residual respiratory tract samples including bronchoalveolar lavage and non-directed bronchoalveolar lavage. Comparisons will be made to conventional diagnostic tests used in the diagnosis of community acquired pneumonia. |
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SCAP requiring ITU support
Patients diagnosed with severe respiratory failure due to community acquired pneumonia that require intensive care support and undergo a routine bronchoscopy for clinical purposes. Molecular laboratory techniques will be applied to residual respiratory tract samples including bronchoalveolar lavage and non-directed bronchoalveolar lavage. Comparisons will be made to conventional diagnostic tests used in the diagnosis of community acquired pneumonia. |
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Healthy controls
Healthy volunteers who undergo bronchoscopy as part of a designated research bronchoscopy list. Molecular laboratory techniques will be applied to bronchoalveolar lavage samples. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples
기간: 28 days (From time of enrollment up until end of inclusion)
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The proportion of pathogen genome that can be detected in bronchial lavage samples detected by the proportion of the sequenced nucleic acid which is pathogen derived and the proportion of the pathogen genome which be reconstructed.
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28 days (From time of enrollment up until end of inclusion)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Metagenomic detection of pathogen genomes compared to the results of conventional diagnostic techniques
기간: 28 days (From time of enrollment up until end of inclusion)
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Metagenomic sequencing data obtained will be compared to results obtained from conventional diagnostic tests undertaken as part of the participant's routine clinical care. Data will be used to evaluate the ability of each technique to detect any pathogens found. The conventional microbiological tests that will be used for comparison include those undertaken as part of the participants routine clinical care and will include urinary antigen tests (Pneumococcal and Leigonella); blood, sputum and bronchial lavage culture including polymerase chain reaction (PCR) for Legionella spp, Mycoplasma pneumoniae and Chlamydophila pneumoniae and respiratory viral PCR multiplex assays. The results of serological tests and PCR for Influenza A &B from nose and throat swabs will also be compared. |
28 days (From time of enrollment up until end of inclusion)
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공동 작업자 및 조사자
수사관
- 연구 의자: Ajit Lalvani, MBBS,MRCP,FRCP, Imperial College London
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .