Invasive AspergillosisNCT01430663
Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples
An observational study of Invasive Aspergillosis, run by Heidelberg University at 9 sites in 2 countries.
Trial summary
Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has… Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Invasive Aspergillosis
- How many people
- 87 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Apr 2007to Feb 2011
- 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 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: hematological patients at high risk for invasive aspergillosis
Who may be able to join
- hematological patients with lung infiltrates at high risk for invasive aspergillosis
Who cannot join
- patients without informed consent
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
Cologne University Hospital
Cologne
Erlangen University Hospital
Erlangen
General Hospital Frankfurt (Oder)
Frankfurt (Oder)
Freiburg University Hospital
Freiburg im Breisgau
Halle University Hospital
Halle
Herne University Hospital
Herne
Mannheim University Hospital
Mannheim, 68167
Würzburg University Hospital
Würzburg
About this study
Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.
- Conditions
- Invasive Aspergillosis
- Keywords
- aspergillosis, bronchoalveolar lavage, galactomannan, pcr, hematological patients
- Medical subject headings
- Aspergillosis, Pathologic Complete Response
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 |
|---|---|---|
| Hematological patients with proven or probable aspergillosis | Not described | |
| Hematological patients with possible aspergillosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis
Measured: up to 18 months
Secondary outcomes (1)
Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startApr 2007
- Primary completionFeb 2011
- Study completionFeb 2011
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Buchheidt, Heidelberg University
- Investigators
- Dieter Buchheidt, MD, Principal investigator, Mannheim University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430663
- Sponsor's protocol ID
- AGIHO BAL GM PCR 2007
- Status last verified
- Apr 2020
- First submitted
- 6 Sep 2011
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Skladny H, Buchheidt D, Baust C, Krieg-Schneider F, Seifarth W, Leib-Mosch C, Hehlmann R. Specific detection of Aspergillus species in blood and bronchoalveolar lavage samples of immunocompromised patients by two-step PCR. J Clin Microbiol. 1999 Dec;37(12):3865-71. doi: 10.1128/JCM.37.12.3865-3871.1999.
PubMed 10565898Buchheidt D, Baust C, Skladny H, Ritter J, Suedhoff T, Baldus M, Seifarth W, Leib-Moesch C, Hehlmann R. Detection of Aspergillus species in blood and bronchoalveolar lavage samples from immunocompromised patients by means of 2-step polymerase chain reaction: clinical results. Clin Infect Dis. 2001 Aug 15;33(4):428-35. doi: 10.1086/321887. Epub 2001 Jul 6.
PubMed 11462176Spiess B, Buchheidt D, Baust C, Skladny H, Seifarth W, Zeilfelder U, Leib-Mosch C, Morz H, Hehlmann R. Development of a LightCycler PCR assay for detection and quantification of Aspergillus fumigatus DNA in clinical samples from neutropenic patients. J Clin Microbiol. 2003 May;41(5):1811-8. doi: 10.1128/JCM.41.5.1811-1818.2003.
PubMed 12734210Hummel M, Spiess B, Cornely OA, Dittmer M, Morz H, Buchheidt D. Aspergillus PCR testing: results from a prospective PCR study within the AmBiLoad trial. Eur J Haematol. 2010 Aug;85(2):164-9. doi: 10.1111/j.1600-0609.2010.01452.x. Epub 2010 Apr 1.
PubMed 20374275
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
- Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples
- ClinicalTrials.gov ID
- NCT01430663
- Acronym / sponsor ID
- AGIHO BAL GM PCR 2007
- Conditions
- Invasive Aspergillosis
- Keywords
- aspergillosis, bronchoalveolar lavage, galactomannan, pcr, hematological patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Sep 2011 (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.
Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematological patients with proven or probable aspergillosis | – | – |
| Hematological patients with possible aspergillosis | – | – |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hematological patients at high risk for invasive aspergillosis
Key inclusion criteria (1 listed)
- hematological patients with lung infiltrates at high risk for invasive aspergillosis
Key exclusion criteria (1 listed)
- patients without informed consent
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
Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis
Time frame: up to 18 months
1 secondary outcome
Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Background: PubMed 10565898Skladny H, Buchheidt D, Baust C, Krieg-Schneider F, Seifarth W, Leib-Mosch C, Hehlmann R. Specific detection of Aspergillus species in blood and bronchoalveolar lavage samples of immunocompromised patients by two-step PCR. J Clin Microbiol. 1999 Dec;37(12):3865-71. doi: 10.1128/JCM.37.12.3865-3871.1999.
- Background: PubMed 11462176Buchheidt D, Baust C, Skladny H, Ritter J, Suedhoff T, Baldus M, Seifarth W, Leib-Moesch C, Hehlmann R. Detection of Aspergillus species in blood and bronchoalveolar lavage samples from immunocompromised patients by means of 2-step polymerase chain reaction: clinical results. Clin Infect Dis. 2001 Aug 15;33(4):428-35. doi: 10.1086/321887. Epub 2001 Jul 6.
- Background: PubMed 12734210Spiess B, Buchheidt D, Baust C, Skladny H, Seifarth W, Zeilfelder U, Leib-Mosch C, Morz H, Hehlmann R. Development of a LightCycler PCR assay for detection and quantification of Aspergillus fumigatus DNA in clinical samples from neutropenic patients. J Clin Microbiol. 2003 May;41(5):1811-8. doi: 10.1128/JCM.41.5.1811-1818.2003.
- Background: PubMed 20374275Hummel M, Spiess B, Cornely OA, Dittmer M, Morz H, Buchheidt D. Aspergillus PCR testing: results from a prospective PCR study within the AmBiLoad trial. Eur J Haematol. 2010 Aug;85(2):164-9. doi: 10.1111/j.1600-0609.2010.01452.x. Epub 2010 Apr 1.
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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.
Dieter Buchheidt, MD principal investigator
Mannheim University Hospital
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Aspergillosis, run by Heidelberg University at 9 sites in 2 countries.
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 1 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: finished, 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 9 sites in Germany, Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis (time frame: up to 18 months). 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 NCT01430663, 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.