Invasive Pulmonary AspergillosisDipA2NCT04848831
Diagnosis of Invasive Pulmonary Aspergillosis, Specific Testing in Bronchial Secretions Versus Bronchoalveolar Fluid
An observational study of Invasive Pulmonary Aspergillosis, run by Universitätsklinikum Hamburg-Eppendorf.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Pulmonary Aspergillosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age: at least 18 years
- Consent to prospective data collection.
- Clinical need for bronchoscopic examination.
Who cannot join
- Refusal of consent to study participation
Trial locations and contacts
No sites are listed yet.
Dominic Wichman, MD contact
About this study
Official title: Diagnosis of Invasive Pulmonary Aspergillosis (IPA) - Specific Testing in Bronchial Secretions Versus Bronchoalveolar Fluid in Patients With and Without COVID-19
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.
Read the detailed description
Invasive pulmonary Infection with Aspergillus species has emerged as one of the most common causes of infectious death in critically ill patients (38%-79%). The incidence of invasive pulmonary Aspergillosis (IPA) in intensive care units is still not sufficiently clear and ranges between 0.3 % and 19 %. In the last two decades, IPA has been documented as an emerging disease in ICU patients without classic risk factors. The establishment of new therapeutic options in oncology with small-molecule kinase inhibitors (SMKI) and CAR (chimeric antigen receptor) T cell therapy have also led to an increase in IPA. Furthermore, during the influenza epidemics since 2009 and during the SARS-CoV-2 pandemic, IPA was observed in COVID-19 patients without classic risk factors. The cultural detection of molds can take between several days and up to 2 weeks, as this is a slow growing fungus. An Aspergillus Galactomannan EIA (enzyme immunoassay), an Aspergillus PCR (polymerase chain reaction) examination of the respiratory tract material is already available after 4-24 hours. A test using Aspergillus Galactomannan LFA (lateral flow assay) or LFD (lateral flow device) even furthers reduces this interval to 45 minutes. These tests allow the attending physician to initiate a much faster antimycotic treatment. Up to now, the samples for these examinations have been routinely obtained from bronchoscopically obtained bronchoalveolar lavage fluids. In this bronchoalveolar lavage (BAL), body-warm saline solution (NaCl) is instilled into segmental ostia of the lung and immediately re-aspirated . However, there are first indications that examinations from bronchial secretions using deep suction without bronchoscopy achieve similar results to the examination of the BAL. The bronchoscopic diagnosis in COVID-19 patients is probably associated with an increased risk of infection for the examiner due to the aerosol formation during this examination. Two studies from the first wave of the SARS-CoV-2 pandemic have therefore used secretions from the bronchial system = non-bronchoscopic lavage (NBL) to diagnose IPA. This method appears to be reasonable save, appropriate and less risky, but has never been scientifically validated for aspergillus infections. It is not yet clear whether the Aspergillus Galactomannan EIA, the Aspergillus PCR test and the Aspergillus LFA test provide comparable or transmissible results in both lung compartments. A direct comparison of the test results of the bronchoalveolar lavage (BAL) and the bronchial secretion (NBL) have not been described in the literature.
Study Design:
Monocentric prospective exploratory (and in the course confirmatory) cohort study.
- st pilot phase: Pilot study to test the feasibility and to gain information for the case number calculation of a subsequent larger prospective study.
- nd study phase: The statistically calculated number of patients who undergo a bronchoscopy during their stay at the UKE and who are urgently suspected of having IPA or who are confirmed to have IPA will be examined for bronchial secretions (NBL) and BAL fluids.
- Conditions
- Invasive Pulmonary Aspergillosis
- Keywords
- IPA, Aspergillus, Galactomannan, Aspergillus PCR, Aspergillus LFA, Bronchoscopy
- Medical subject headings
- Invasive Pulmonary Aspergillosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
One patients results are same, positive or negative in both lung compartments (BAL and NBL).
Measured: 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.
One patients results are same, positive or negative in both lung compartments (BAL and NBL).
Measured: The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Invasive Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Schroeder, MD, Principal investigator, University Medical Center Hamburg-Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848831
- Sponsor's protocol ID
- DipA2
- Acronym
- DipA2
- Status last verified
- Apr 2021
- First submitted
- 7 Feb 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25928694Loughlin 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.
PubMed 32609533Meersseman 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.
PubMed 17646965Latge 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.
PubMed 31722890Wauters 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.
PubMed 22895826Schauwvlieghe 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.
PubMed 30076119van 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.
PubMed 32396381Rutsaert 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.
PubMed 32488446Nasir 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.
PubMed 32585069Koehler 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.
PubMed 32339350Dalhoff 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.
PubMed 29341032Lass-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.
PubMed 31445208Van 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.
PubMed 32668167White 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.
PubMed 32860682Schroeder 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.
PubMed 39900777
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Invasive Pulmonary Aspergillosis (IPA) - Specific Testing in Bronchial Secretions Versus Bronchoalveolar Fluid in Patients With and Without COVID-19
- ClinicalTrials.gov ID
- NCT04848831
- Acronym / sponsor ID
- DipA2 / DipA2
- Conditions
- Invasive Pulmonary Aspergillosis
- Keywords
- IPA, Aspergillus, Galactomannan, Aspergillus PCR, Aspergillus LFA, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Invasive pulmonary Infection with Aspergillus species has emerged as one of the most common causes of infectious death in critically ill patients (38%-79%). The incidence of invasive pulmonary Aspergillosis (IPA) in intensive care units is still not sufficiently clear and ranges between 0.3 % and 19 %. In the last two decades, IPA has been documented as an emerging disease in ICU patients without classic risk factors. The establishment of new therapeutic options in oncology with small-molecule kinase inhibitors (SMKI) and CAR (chimeric antigen receptor) T cell therapy have also led to an increase in IPA. Furthermore, during the influenza epidemics since 2009 and during the SARS-CoV-2 pandemic, IPA was observed in COVID-19 patients without classic risk factors. The cultural detection of molds can take between several days and up to 2 weeks, as this is a slow growing fungus. An Aspergillus Galactomannan EIA (enzyme immunoassay), an Aspergillus PCR (polymerase chain reaction) examination of the respiratory tract material is already available after 4-24 hours. A test using Aspergillus Galactomannan LFA (lateral flow assay) or LFD (lateral flow device) even furthers reduces this interval to 45 minutes. These tests allow the attending physician to initiate a much faster antimycotic treatment. Up to now, the samples for these examinations have been routinely obtained from bronchoscopically obtained bronchoalveolar lavage fluids. In this bronchoalveolar lavage (BAL), body-warm saline solution (NaCl) is instilled into segmental ostia of the lung and immediately re-aspirated . However, there are first indications that examinations from bronchial secretions using deep suction without bronchoscopy achieve similar results to the examination of the BAL. The bronchoscopic diagnosis in COVID-19 patients is probably associated with an increased risk of infection for the examiner due to the aerosol formation during this examination. Two studies from the first wave of the SARS-CoV-2 pandemic have therefore used secretions from the bronchial system = non-bronchoscopic lavage (NBL) to diagnose IPA. This method appears to be reasonable save, appropriate and less risky, but has never been scientifically validated for aspergillus infections. It is not yet clear whether the Aspergillus Galactomannan EIA, the Aspergillus PCR test and the Aspergillus LFA test provide comparable or transmissible results in both lung compartments. A direct comparison of the test results of the bronchoalveolar lavage (BAL) and the bronchial secretion (NBL) have not been described in the literature.
Study Design:
Monocentric prospective exploratory (and in the course confirmatory) cohort study.
- st pilot phase: Pilot study to test the feasibility and to gain information for the case number calculation of a subsequent larger prospective study.
- nd study phase: The statistically calculated number of patients who undergo a bronchoscopy during their stay at the UKE and who are urgently suspected of having IPA or who are confirmed to have IPA will be examined for bronchial secretions (NBL) and BAL fluids.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age: at least 18 years
- Consent to prospective data collection.
- Clinical need for bronchoscopic examination.
Key exclusion criteria (1 listed)
- Refusal of consent to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Equivalence of quantitative results of Aspergillus galactomannan EIA examination from bronchial secretions (NBL) and BAL in one patient.
Time frame: The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).
The Aspergillus antigen findings (galactomannan-EIA) quantitative show now deviation
2 secondary outcomes
Number of matched results (within a study participant) of Aspergillus PCR examination from BAL and NBL.
Time frame: 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.
Time frame: The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Background: PubMed 25928694Taccone 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.
- Background: PubMed 32609533Loughlin 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.
- Background: PubMed 17646965Meersseman 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.
- Background: PubMed 31722890Latge 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.
- Background: PubMed 22895826Wauters 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.
- Background: PubMed 30076119Schauwvlieghe 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.
- Background: PubMed 32396381van 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.
- Background: PubMed 32488446Rutsaert 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.
- Background: PubMed 32585069Nasir 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.
- Background: PubMed 32339350Koehler 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.
- Background: PubMed 29341032Dalhoff 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.
- Background: PubMed 31445208Lass-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominic Wichman, MD contact
Maria Schroeder, MD principal investigator
University Medical Center Hamburg-Eppendorf, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Pulmonary Aspergillosis, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Schroeder, MD (00491522815826, m.metschke@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of quantitative results of Aspergillus galactomannan EIA examination from bronchial secretions (NBL) and BAL in one patient. (time frame: The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848831, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.