- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01902030
Evaluation of Performance of An Aspergillus PCR in Tissue and Pleural Effusion Samples of Immunocompromised Patients
Diagnostic Study of Performance of an Aspergillus Specific Polymerase Chain Reaction in Tissue and Pleural Effusion Samples of Immunocompromised Patients for the Diagnosis of Invasive Aspergillosis
Although being a frequent and lethal complication in patients (pts) with hematologic malignancies, diagnosing invasive aspergillosis (IA) still remains a difficult issue as culture-based methods show low sensitivity especially under the current clinical practice of antifungal prophylaxis or rapid antifungal therapy. In certain clinical settings, performing biopsies for identification of the underlying infectious organism becomes important. However, as culture-based methods only yield results in a minority of patients, using non-culture-based methods like Aspergillus specific polymerase chain reaction (PCR) for detection of IA directly in clinical specimens is becoming increasingly important and might help to characterize the causative pathogen.
Therefore the performance of an established Aspergillus-specific nested PCR in biopsies, re-section material or pleural effusions is evaluated.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Cologne, 독일, 50937
- Cologne University Hospital
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Duesseldorf, 독일, 40225
- Duesseldorf University Hospital
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Eschweiler, 독일, 52249
- Eschweiler General Hospital
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Frankfurt (Oder), 독일, 15236
- Frankfurt (Oder) General Hospital
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Freiburg, 독일, 79106
- Freiburg University Hospital
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Halle (Saale), 독일
- Halle University Hospital
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Heidelberg, 독일, 68167
- Thoraxklinik at Heidelberg University Hospital
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Herne, 독일, 44625
- Marienhospital Herne
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Mannheim, 독일, 68167
- Mannheim University Hospital
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Recklinghausen, 독일
- Prosper Hospital Recklinghausen
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Wiesbaden, 독일
- Wiesbaden Bone Marrow transplantation center
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Wuerzburg, 독일, 97080
- Wuerzburg University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
- Immunocompromised individuals with suspicion of harbouring an invasive fungal infection
설명
Inclusion Criteria:
- Immunocompromised individuals with suspicion of harbouring an invasive fungal infection
- Definition by 2008 EORTC/MSG Criteria (de Pauw CID 2008)
Exclusion Criteria:
- none
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Proven/Probable IA Patients
Case Population
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possible/No IA Patients
Control population
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio
기간: 3 months
|
Evaluation of Sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio of aspergillus specific PCR in tissue and effusion samples by comparing the population with proven / probable invasive aspergillosis with patients suffering from No IA according to recent EORTC/MSG criteria of PCR in Biopsies/Effusion samples of Patients
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dieter Buchheidt, MD, Heidelberg University
간행물 및 유용한 링크
일반 간행물
- Spiess B, Seifarth W, Hummel M, Frank O, Fabarius A, Zheng C, Morz H, Hehlmann R, Buchheidt D. DNA microarray-based detection and identification of fungal pathogens in clinical samples from neutropenic patients. J Clin Microbiol. 2007 Nov;45(11):3743-53. doi: 10.1128/JCM.00942-07. Epub 2007 Aug 22.
- Boch T, Reinwald M, Postina P, Cornely OA, Vehreschild JJ, Heussel CP, Heinz WJ, Hoenigl M, Eigl S, Lehrnbecher T, Hahn J, Claus B, Lauten M, Egerer G, Muller MC, Will S, Merker N, Hofmann WK, Buchheidt D, Spiess B. Identification of invasive fungal diseases in immunocompromised patients by combining an Aspergillus specific PCR with a multifungal DNA-microarray from primary clinical samples. Mycoses. 2015 Dec;58(12):735-45. doi: 10.1111/myc.12424. Epub 2015 Oct 26.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .