Diagnosis of Invasive Pulmonary Aspergillosis, Specific Testing in Bronchial Secretions Versus Bronchoalveolar Fluid

NCT04848831 | Unknown

• 1 other identifier: DipA2
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this research project is to compare the results of Aspergillus specific test methods Aspergillus Galactomannan Enzyme Immunoassay (GM-EIA), Aspergillus polymerase chain reaction (PCR), Aspergillus Galactomannan Lateral Flow Assay (LFA) from different respiratory tract secretions. The bronchoalveolar lavage (BAL) fluid and bronchial secretions (NBL) are compared in the same examination for each patient.

Conditions

Invasive Pulmonary Aspergillosis

Keywords

IPA; Aspergillus; Galactomannan; Aspergillus PCR; Aspergillus LFA; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Equivalence of quantitative results of Aspergillus galactomannan EIA examination from bronchial secretions (NBL) and BAL in one patient.

  The Aspergillus antigen findings (galactomannan-EIA) quantitative show now deviation

  The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).

Secondary Outcomes (2)

• Number of matched results (within a study participant) of Aspergillus PCR examination from BAL and NBL.

  The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).

• Number of matched results (within a study participant) of Aspergillus galactomannan LFA examination from BAL and NBL.

  The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

4\) Suspicion of invasive pulmonary aspergillosis: (a) Clinical: * Neutropenia * Hematooncological disease * Allogeneic stem cell transplantation * Organ transplantation * SARS-CoV-2 * Influenza b) Radiological: * Aspergillus typical findings on computed tomography. c) Microbiological: * Aspergillus positive findings from respiratory tract secretions (culture, galactomannan, PCR) or d) Confirmed invasive pulmonary aspergillosis.

You may qualify if:

• Age: at least 18 years
• Consent to prospective data collection.
• Clinical need for bronchoscopic examination.

You may not qualify if:

• Refusal of consent to study participation

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Related Publications (15)

• Taccone FS, Van den Abeele AM, Bulpa P, Misset B, Meersseman W, Cardoso T, Paiva JA, Blasco-Navalpotro M, De Laere E, Dimopoulos G, Rello J, Vogelaers D, Blot SI; AspICU Study Investigators. Epidemiology of invasive aspergillosis in critically ill patients: clinical presentation, underlying conditions, and outcomes. Crit Care. 2015 Jan 12;19(1):7. doi: 10.1186/s13054-014-0722-7.

  PMID: 25928694 BACKGROUND

• Loughlin L, Hellyer TP, White PL, McAuley DF, Conway Morris A, Posso RB, Richardson MD, Denning DW, Simpson AJ, McMullan R. Pulmonary Aspergillosis in Patients with Suspected Ventilator-associated Pneumonia in UK ICUs. Am J Respir Crit Care Med. 2020 Oct 15;202(8):1125-1132. doi: 10.1164/rccm.202002-0355OC.

  PMID: 32609533 BACKGROUND

• Meersseman W, Van Wijngaerden E. Invasive aspergillosis in the ICU: an emerging disease. Intensive Care Med. 2007 Oct;33(10):1679-81. doi: 10.1007/s00134-007-0792-y. Epub 2007 Jul 24. No abstract available.

  PMID: 17646965 BACKGROUND

• Latge JP, Chamilos G. Aspergillus fumigatus and Aspergillosis in 2019. Clin Microbiol Rev. 2019 Nov 13;33(1):e00140-18. doi: 10.1128/CMR.00140-18. Print 2019 Dec 18.

  PMID: 31722890 BACKGROUND

• Wauters J, Baar I, Meersseman P, Meersseman W, Dams K, De Paep R, Lagrou K, Wilmer A, Jorens P, Hermans G. Invasive pulmonary aspergillosis is a frequent complication of critically ill H1N1 patients: a retrospective study. Intensive Care Med. 2012 Nov;38(11):1761-8. doi: 10.1007/s00134-012-2673-2. Epub 2012 Aug 16.

  PMID: 22895826 BACKGROUND

• Schauwvlieghe AFAD, Rijnders BJA, Philips N, Verwijs R, Vanderbeke L, Van Tienen C, Lagrou K, Verweij PE, Van de Veerdonk FL, Gommers D, Spronk P, Bergmans DCJJ, Hoedemaekers A, Andrinopoulou ER, van den Berg CHSB, Juffermans NP, Hodiamont CJ, Vonk AG, Depuydt P, Boelens J, Wauters J; Dutch-Belgian Mycosis study group. Invasive aspergillosis in patients admitted to the intensive care unit with severe influenza: a retrospective cohort study. Lancet Respir Med. 2018 Oct;6(10):782-792. doi: 10.1016/S2213-2600(18)30274-1. Epub 2018 Jul 31.

  PMID: 30076119 BACKGROUND

• van Arkel ALE, Rijpstra TA, Belderbos HNA, van Wijngaarden P, Verweij PE, Bentvelsen RG. COVID-19-associated Pulmonary Aspergillosis. Am J Respir Crit Care Med. 2020 Jul 1;202(1):132-135. doi: 10.1164/rccm.202004-1038LE. No abstract available.

  PMID: 32396381 BACKGROUND

• Rutsaert L, Steinfort N, Van Hunsel T, Bomans P, Naesens R, Mertes H, Dits H, Van Regenmortel N. COVID-19-associated invasive pulmonary aspergillosis. Ann Intensive Care. 2020 Jun 1;10(1):71. doi: 10.1186/s13613-020-00686-4. No abstract available.

  PMID: 32488446 BACKGROUND

• Nasir N, Farooqi J, Mahmood SF, Jabeen K. COVID-19-associated pulmonary aspergillosis (CAPA) in patients admitted with severe COVID-19 pneumonia: An observational study from Pakistan. Mycoses. 2020 Aug;63(8):766-770. doi: 10.1111/myc.13135. Epub 2020 Jul 18.

  PMID: 32585069 BACKGROUND

• Koehler P, Cornely OA, Bottiger BW, Dusse F, Eichenauer DA, Fuchs F, Hallek M, Jung N, Klein F, Persigehl T, Rybniker J, Kochanek M, Boll B, Shimabukuro-Vornhagen A. COVID-19 associated pulmonary aspergillosis. Mycoses. 2020 Jun;63(6):528-534. doi: 10.1111/myc.13096. Epub 2020 May 15.

  PMID: 32339350 BACKGROUND

• Dalhoff K, Abele-Horn M, Andreas S, Deja M, Ewig S, Gastmeier P, Gatermann S, Gerlach H, Grabein B, Heussel CP, Hoffken G, Kolditz M, Kramme E, Kuhl H, Lange C, Mayer K, Nachtigall I, Panning M, Pletz M, Rath PM, Rohde G, Rosseau S, Schaaf B, Schreiter D, Schutte H, Seifert H, Spies C, Welte T; Unter Mitwirkung der folgenden Wissenschaftlichen Fachgesellschaften und Institutionen: Deutsche Gesellschaft fur Chirurgie; Deutsche Gesellschaft fur Innere Medizin e. V.; Deutsche Gesellschaft fur Internistische Intensivmedizin und Notfallmedizin; Deutsche Sepsis-Gesellschaft e. V.; und Robert Koch-Institut. [Epidemiology, Diagnosis and Treatment of Adult Patients with Nosocomial Pneumonia - Update 2017 - S3 Guideline of the German Society for Anaesthesiology and Intensive Care Medicine, the German Society for Infectious Diseases, the German Society for Hygiene and Microbiology, the German Respiratory Society and the Paul-Ehrlich-Society for Chemotherapy, the German Radiological Society and the Society for Virology]. Pneumologie. 2018 Jan;72(1):15-63. doi: 10.1055/s-0043-121734. Epub 2018 Jan 16. German.

  PMID: 29341032 BACKGROUND

• Lass-Florl C, Lo Cascio G, Nucci M, Camargo Dos Santos M, Colombo AL, Vossen M, Willinger B. Respiratory specimens and the diagnostic accuracy of Aspergillus lateral flow assays (LFA-IMMY): real-life data from a multicentre study. Clin Microbiol Infect. 2019 Dec;25(12):1563.e1-1563.e3. doi: 10.1016/j.cmi.2019.08.009. Epub 2019 Aug 22.

  PMID: 31445208 BACKGROUND

• Van Biesen S, Kwa D, Bosman RJ, Juffermans NP. Detection of Invasive Pulmonary Aspergillosis in COVID-19 with Nondirected BAL. Am J Respir Crit Care Med. 2020 Oct 15;202(8):1171-1173. doi: 10.1164/rccm.202005-2018LE. No abstract available.

  PMID: 32668167 BACKGROUND

• White PL, Dhillon R, Cordey A, Hughes H, Faggian F, Soni S, Pandey M, Whitaker H, May A, Morgan M, Wise MP, Healy B, Blyth I, Price JS, Vale L, Posso R, Kronda J, Blackwood A, Rafferty H, Moffitt A, Tsitsopoulou A, Gaur S, Holmes T, Backx M. A National Strategy to Diagnose Coronavirus Disease 2019-Associated Invasive Fungal Disease in the Intensive Care Unit. Clin Infect Dis. 2021 Oct 5;73(7):e1634-e1644. doi: 10.1093/cid/ciaa1298.

  PMID: 32860682 BACKGROUND

• Schroeder M, Raboh MA, Nuechtern A, Wichmann D, Stamm J, Hardel T, Rohde H, Christner M, Ozga AK, Steurer S, Jafari C, Klose H, Kluge S, Simon M, Fischer M. Comparison of the Equivalence of Aspergillus Antigen and PCR Results Between Non-Directed Bronchial Lavage and Bronchoalveolar Lavage-A Prospective Exploratory Pilot Study in Critically Ill Patients. Mycoses. 2025 Feb;68(2):e70029. doi: 10.1111/myc.70029.

  PMID: 39900777 DERIVED

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maria Schroeder, MD

  University Medical Center Hamburg-Eppendorf, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Schroeder, MD

CONTACT

00491522815826; m.metschke@uke.de

Dominic Wichman, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: April 19, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share