Clinical Trial: Bronchoalveolar Lavage Lateral-Flow Device Test for Invasive Pulmonary Aspergillosis: a Multicenter Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Bronchoalveolar Lavage Lateral-Flow Device Test for Invasive Pulmonary Aspergillosis: a Multicenter Study
Brief Summary:
Background Invasive pulmonary aspergillosis (IPA) remains an important cause of morbidity and mortality among patients with hemato-oncological malignancies. Due to the crude mortality of >90% in absence of adequate treatment, timely diagnosis and early start of antifungal therapy are key factors in the successful treatment of IPA. Various studies have shown that early initiation of antifungal therapy may improve IPA survival to above 70%. Diagnosis of IPA, however, remains difficult as clinical signs and symptoms as well as radiological findings are often unspecific and conventional culture methods lack sensitivity. In recent years antigen testing has therefore become one of the cornerstones of IPA diagnostics. Brochoalveolar lavage (BAL) Galactomannan (GM) testing is currently the most promising approach for early detection of pulmonary infections by this fungus. However, limitations of GM detection are assay turn-around time, which varies widely between centers (less than a day to several days), and the need for appropriately equipped laboratories that routinely test for this antigen. These limitations are overcome by the Aspergillus Lateral-Flow Device (LFD), a novel point-of-care (POC) test for IPA diagnosis developed by Dr Thornton at the University of Exeter, UK. This simple, rapid (15 min), single-use test can be performed in rudimentary facilities using BAL specimens. In a retrospective single centre study we have recently evaluated the LFD test in 39 BAL samples from hematologic malignancy patients and solid organ transplant recipients. Sensitivities and specificities of BAL LFD tests for probable IPA were 100% and 81%, respectively. Galactomannan levels in cases with negative LFD were significantly lower than in patients with positive LFD (P <0.0001). We concluded that the LFD test of BAL specimens is performed easily and provides accurate and rapidly available results. Therefore, this new point-of-care t
Detailed Summary:
Project Outlook Sensitive and specific biomarkers for early diagnosis of IPA are urgently needed to improve survival. In this multicenter study we will evaluate the potential of the novel Lateral Flow Device test for early, bedside diagnosis of IPA.
A successful implementation of the studies hypothesis requires a solid background in the field of IPA. Considering this I am confident that my professional experience combined with the technical and scientific expertise at my host institute and the associated laboratories generates a highly competitive and promising setting. The success of the proposed research will vitally depend on collaborations. Over the last four years I have worked extensively in the field of IPA among patients with hemato-oncological malignancies, which allowed me to establish the necessary contacts and cooperations that are vital for the project's success. The major strength of this multi-center study is therefore the cooperation with three major centers for IPA diagnosis under the leadership of three outstanding experts (Prof. Lass-Flörl, Prof. Buchheidt and Prof. Willinger) who have published extensively in the field of IPA diagnosis over recent years/decades. I am certain that our results will have far-reaching implementations for the whole field of IPA. Clearly, they will significantly advance our understanding of the clinical performance of the novel point of care applications.
The project is expected to have a big impact on patient care. Establishment of the Lateral Flow Device test may lead to rapidly, frankly on the bedside, available test results and may therefore enable earlier initiation of appropriate antifungal therapy which may help to save lives.
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Background
Sponsor: Medical University of Graz
Current Primary Outcome: Performance of the Lateral Flow Device Test for diagnosisng of invasive pulmonary aspergillosis in BAL fluids [ Time Frame: Day 1 ]
BAL fluid s of included patients will be tested with the LFD. Results will be compared to other diagnostics.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medical University of Graz
Dates:
Date Received: January 20, 2014
Date Started: February 2013
Date Completion: July 2018
Last Updated: March 28, 2017
Last Verified: March 2017
