INvasive AspergillosisNCT01695499
Diagnostic Study of Biomarkers in BAL of ICU Patients With Lung Infiltrates
An observational study of INvasive Aspergillosis and Mechanical Ventilation, run by Heidelberg University at 1 site in Germany.
Trial summary
The aim of this project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR assays in addition to conventional… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- INvasive Aspergillosis, Mechanical Ventilation, Lung Infiltrates
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Dec 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Immunocompromised patients on the intensive care unit with lun infiltrates and one of the following underlying conditions: * Underlying malignancy * Antineoplastic chemotherapy * Neutropenia * Allogeneic hematopoietic stem cell transplantation * Solid organ transplantation * Retransplantation * Acute or chronic immunological rejection or graft-versus-host-disease * Treatment with immunosuppressive agents (calcineurin inhibitors, OKT3, etc) * Profound systemic corticosteroid therapy prior to ICU admission * COPD Gold III/IV * Advanced liver cirrhosis and ICU treatment for more than 7 days * Hemodialysis, renal failure * CMV infection * HIV infection; CD4 cellcount * Post splenectomy * Post cardiac surgery * Diabetes mellitus * mechanical ventilation for more than 21 days * ICU-based steroid therapy and corticosteroid treatment for more than 7 days * Malnutrition * Severe burn wounds
Who may be able to join
- underlying conditions (see above)
- being on mechanical ventilation
- lung infiltrates
Who cannot join
- immunocompetent patients (not fulfilling the criteria above)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Prospective, Multicenter Trial to Evaluate the Clinical Significance of Combined Serological (Galactomannan ELISA, Beta D Glucan Assay) and Molecular (Nested Aspergillus PCR Assay, Real-time qPCR Assay, Multifungal DNA Microarray) Diagnostic Assays to Detect and Characterize Fungal Pathogens in Bronchoalveolar Lavage (BAL)and Blood Samples of Intensive Care Unit Patients With Pulmonary Infiltrates
The aim of this project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts with pulmonary infiltrates.
As GM and BDG are not species-specific, three established and repeatedly published species specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed by our group will be investigated in combination with the serological tests in a multicenter prospective clinical diagnostic trial.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppressed ICU Patients with lung infiltrates | Immunosuppressed ICU Patients with lung infiltrates | |
| Control Group | BAL and blood aliquots of 20 immunocompetent pts (suffering from lung diseases) will be collected and tested identically as a control population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty
Evaluation of diagnostic accuracy of the combined biomarker approach
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for INvasive AspergillosisStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dieter Buchheidt, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695499
- Sponsor's protocol ID
- BAL-Biomarker-ICU Study
- Other IDs
- Grant Pfizer ASPIRE Award
- Status last verified
- Apr 2020
- First submitted
- 26 Sep 2012
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Reinwald M, Hummel M, Kovalevskaya E, Spiess B, Heinz WJ, Vehreschild JJ, Schultheis B, Krause SW, Claus B, Suedhoff T, Schwerdtfeger R, Reuter S, Kiehl MG, Hofmann WK, Buchheidt D. Therapy with antifungals decreases the diagnostic performance of PCR for diagnosing invasive aspergillosis in bronchoalveolar lavage samples of patients with haematological malignancies. J Antimicrob Chemother. 2012 Sep;67(9):2260-7. doi: 10.1093/jac/dks208. Epub 2012 Jun 27.
PubMed 22740590Reinwald M, Spiess B, Heinz WJ, Vehreschild JJ, Lass-Florl C, Kiehl M, Schultheis B, Krause SW, Wolf HH, Bertz H, Maschmeyer G, Hofmann WK, Buchheidt D. Diagnosing pulmonary aspergillosis in patients with hematological malignancies: a multicenter prospective evaluation of an Aspergillus PCR assay and a galactomannan ELISA in bronchoalveolar lavage samples. Eur J Haematol. 2012 Aug;89(2):120-7. doi: 10.1111/j.1600-0609.2012.01806.x. Epub 2012 Jun 22.
PubMed 22650156Spiess B, Seifarth W, Merker N, Howard SJ, Reinwald M, Dietz A, Hofmann WK, Buchheidt D. Development of novel PCR assays to detect azole resistance-mediating mutations of the Aspergillus fumigatus cyp51A gene in primary clinical samples from neutropenic patients. Antimicrob Agents Chemother. 2012 Jul;56(7):3905-10. doi: 10.1128/AAC.05902-11. Epub 2012 Apr 23.
PubMed 22526309Boch T, Reinwald M, Spiess B, Liebregts T, Schellongowski P, Meybohm P, Rath PM, Steinmann J, Trinkmann F, Britsch S, Michels JD, Jabbour C, Hofmann WK, Buchheidt D. Detection of invasive pulmonary aspergillosis in critically ill patients by combined use of conventional culture, galactomannan, 1-3-beta-D-glucan and Aspergillus specific nested polymerase chain reaction in a prospective pilot study. J Crit Care. 2018 Oct;47:198-203. doi: 10.1016/j.jcrc.2018.07.001. Epub 2018 Jul 4.
PubMed 30015290
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Multicenter Trial to Evaluate the Clinical Significance of Combined Serological (Galactomannan ELISA, Beta D Glucan Assay) and Molecular (Nested Aspergillus PCR Assay, Real-time qPCR Assay, Multifungal DNA Microarray) Diagnostic Assays to Detect and Characterize Fungal Pathogens in Bronchoalveolar Lavage (BAL)and Blood Samples of Intensive Care Unit Patients With Pulmonary Infiltrates
- ClinicalTrials.gov ID
- NCT01695499
- Acronym / sponsor ID
- BAL-Biomarker-ICU Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2012
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Sep 2012 (estimated)
- 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 project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts with pulmonary infiltrates.
As GM and BDG are not species-specific, three established and repeatedly published species specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed by our group will be investigated in combination with the serological tests in a multicenter prospective clinical diagnostic trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunosuppressed ICU Patients with lung infiltrates | – | –Immunosuppressed ICU Patients with lung infiltrates |
| Control Group | – | –BAL and blood aliquots of 20 immunocompetent pts (suffering from lung diseases) will be collected and tested identically as a control population. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Immunocompromised patients on the intensive care unit with lun infiltrates and one of the following underlying conditions: * Underlying malignancy * Antineoplastic chemotherapy * Neutropenia * Allogeneic hematopoietic stem cell transplantation * Solid organ transplantation * Retransplantation * Acute or chronic immunological rejection or graft-versus-host-disease * Treatment with immunosuppressive agents (calcineurin inhibitors, OKT3, etc) * Profound systemic corticosteroid therapy prior to ICU admission * COPD Gold III/IV * Advanced liver cirrhosis and ICU treatment for more than 7 days * Hemodialysis, renal failure * CMV infection * HIV infection; CD4 cellcount * Post splenectomy * Post cardiac surgery * Diabetes mellitus * mechanical ventilation for more than 21 days * ICU-based steroid therapy and corticosteroid treatment for more than 7 days * Malnutrition * Severe burn wounds
Key inclusion criteria (3 listed)
- underlying conditions (see above)
- being on mechanical ventilation
- lung infiltrates
Key exclusion criteria (1 listed)
- immunocompetent patients (not fulfilling the criteria above)
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
Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty
Time frame: 6 weeks
Evaluation of diagnostic accuracy of the combined biomarker approach
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Background: PubMed 22740590Reinwald M, Hummel M, Kovalevskaya E, Spiess B, Heinz WJ, Vehreschild JJ, Schultheis B, Krause SW, Claus B, Suedhoff T, Schwerdtfeger R, Reuter S, Kiehl MG, Hofmann WK, Buchheidt D. Therapy with antifungals decreases the diagnostic performance of PCR for diagnosing invasive aspergillosis in bronchoalveolar lavage samples of patients with haematological malignancies. J Antimicrob Chemother. 2012 Sep;67(9):2260-7. doi: 10.1093/jac/dks208. Epub 2012 Jun 27.
- Background: PubMed 22650156Reinwald M, Spiess B, Heinz WJ, Vehreschild JJ, Lass-Florl C, Kiehl M, Schultheis B, Krause SW, Wolf HH, Bertz H, Maschmeyer G, Hofmann WK, Buchheidt D. Diagnosing pulmonary aspergillosis in patients with hematological malignancies: a multicenter prospective evaluation of an Aspergillus PCR assay and a galactomannan ELISA in bronchoalveolar lavage samples. Eur J Haematol. 2012 Aug;89(2):120-7. doi: 10.1111/j.1600-0609.2012.01806.x. Epub 2012 Jun 22.
- Background: PubMed 22526309Spiess B, Seifarth W, Merker N, Howard SJ, Reinwald M, Dietz A, Hofmann WK, Buchheidt D. Development of novel PCR assays to detect azole resistance-mediating mutations of the Aspergillus fumigatus cyp51A gene in primary clinical samples from neutropenic patients. Antimicrob Agents Chemother. 2012 Jul;56(7):3905-10. doi: 10.1128/AAC.05902-11. Epub 2012 Apr 23.
- Derived from this study: PubMed 30015290Boch T, Reinwald M, Spiess B, Liebregts T, Schellongowski P, Meybohm P, Rath PM, Steinmann J, Trinkmann F, Britsch S, Michels JD, Jabbour C, Hofmann WK, Buchheidt D. Detection of invasive pulmonary aspergillosis in critically ill patients by combined use of conventional culture, galactomannan, 1-3-beta-D-glucan and Aspergillus specific nested polymerase chain reaction in a prospective pilot study. J Crit Care. 2018 Oct;47:198-203. doi: 10.1016/j.jcrc.2018.07.001. Epub 2018 Jul 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of INvasive Aspergillosis and Mechanical Ventilation, run by Heidelberg University at 1 site in Germany.
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 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty (time frame: 6 weeks). 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 NCT01695499, which also lists 4 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 20 Apr 2020.