Bronchoalveolar Lavage Lateral-Flow Device Test for Invasive Pulmonary Aspergillosis: a Multicenter Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Medical University of Graz
Sponsor:
Collaborators:
Medical University of Vienna
Medical University Innsbruck
Universitätsmedizin Mannheim
Information provided by (Responsible Party):
Robert Krause, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT02058316
First received: January 20, 2014
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 test may be a very promising diagnostic approach for detecting IPA in BAL specimens from haematological malignancy and SOT patients. For routine clinical use, however, multicenter studies with larger sample sizes also from other patient collectives are necessary. In this multicenter study we will evaluate the LFD test in BAL samples.

Study Objectives Primary Objectives To evaluate the Lateral Flow Device test, a rapid (15 min), point-of-care test for IPA diagnosis using bronchoalveolar lavage (BAL) fluids from patients at risk for IPA.

Secondary Objective To evaluate the potential of BAL Lateral Flow Device test for prognosis in patients with IPA.

Study Design This is a prospective multi-center study conducted in three centers in Austria (Graz, Vienna and Innsbruck) and one centre in Germany (Mannheim). In order to meet the objectives an estimated number of 300 BAL samples from patients at risk for IPA (50 to 100 per centre) will be included in the study cohort. The Lateral Flow Device test will be performed prospectively in BAL samples from the patients and results will be compared to GM results, PCR findings, clinical/radiological findings as well as conventional culture results. In addition, retrospective testing of BAL samples that were previously routinely tested for GM will be performed in up to three participating centers (Graz, Innsbruck and Mannheim) to ensure to reach the proposed number of 300 BAL samples. The treating clinicians will not be informed about BAL Lateral Flow Device test results and the test will therefore have no impact on patient management / treatment decisions.


Condition Intervention
Invasive Pulmonary Aspergillosis
Device: Lateral Flow Device Test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bronchoalveolar Lavage Lateral-Flow Device Test for Invasive Pulmonary Aspergillosis: a Multicenter Study

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Performance of the Lateral Flow Device Test for diagnosisng of invasive pulmonary aspergillosis in BAL fluids [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    BAL fluid s of included patients will be tested with the LFD. Results will be compared to other diagnostics.


Estimated Enrollment: 300
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients at risk for IPA Device: Lateral Flow Device Test
Testing of leftover BAL samples from clinical routine by the lateral flow device test

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All stored or routinely obtained BAL samples from adult patients at risk for invasive pulmonary Aspergillosis will be eligible for study inclusion. The treating clinicians will be blinded to BAL Lateral Flow Device test results and the test will therefore have no impact on patient management / treatment decisions. The treating clinicians will be blinded to BAL Lateral Flow Device test results. Test results will therefore have no impact on clinical / treatment decisions and therefore not affect the included patients.

Underlying diseases, EORTC status of IFI (both available from the clinical order accompanying the BAL sample) and other microbiological/mycological test results will be recorded in an electronic data base. No patient related personal data will be required.

Criteria

Inclusion Criteria:

  • a.) Patients above 18 years of age. b.) BAL sample obtained in clinical routine. c.) At risk for IFI (according to attending clinicians). Risk factors may include:
  • febrile neutropenia
  • induction chemotherapy
  • allogeneic stem cell transplant/graft versus host disease
  • clinical/radiological/mycological findings suspicious for IFI
  • Solid Organ transplantation
  • ICU patient
  • Liver cirrhosis

Exclusion Criteria:

  • a.) Under 18 years of age. b.) No BAL sample obtained in clinical routine. d.) Not at risk for IFI.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058316

Contacts
Contact: Martin Hoenigl, MD, PD +4331638581319 martin.hoenigl@medunigraz.at
Contact: Robert Krause, MD / Prof +4331638581796 robert.krause@medunigraz.at

Locations
Austria
Medical university of Graz Recruiting
Graz, Austria
Principal Investigator: Martin Hoenigl, MD         
Innsbruck medical University Recruiting
Innsbruck, Austria
Principal Investigator: Cornelia Lass-Flörl, MD Prof.         
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Birgit Willinger, Prof.       birgit.willinger@meduni-wien.ac.at   
Principal Investigator: Birgit Willinger, MD         
Germany
University Hospital Mannheim Recruiting
Mannheim, Germany
Principal Investigator: Dieter Buchheidt, MD         
Sponsors and Collaborators
Medical University of Graz
Medical University of Vienna
Medical University Innsbruck
Universitätsmedizin Mannheim
  More Information

No publications provided

Responsible Party: Robert Krause, MD, Univ. Prof., Medical University of Graz
ClinicalTrials.gov Identifier: NCT02058316     History of Changes
Other Study ID Numbers: 25-221
Study First Received: January 20, 2014
Last Updated: February 6, 2014
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Aspergillosis
Invasive Pulmonary Aspergillosis
Pulmonary Aspergillosis
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014