ImmunocompromisedNCT01301755
Diagnosis of Invasive Pulmonary Aspergillosis by Direct Lung Tissue Aspergillus Galactomannan Antigen Detection From Aspirate by Ultrasound-guided Fine Needle Aspiration
An observational study of Immunocompromised, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic or have undergone solid organ or stem cell transplantation. However, early diagnosis of invasive aspergillosis is a challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocompromised
- What is being tested?
- Lung aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2010to Feb 2012
- 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: immunocompromised patients
Who may be able to join
- Eligible patients with following host factors:
- A hematologic malignancy, unless they were already treated with antifungals for a presumed or proven IA
- Cancer and receiving chemotherapy within the last 3 months before admission
- Solid organ transplant recipient
- Prolong steroid use
- Recipient of any other immunosuppressive treatment (tacrolimus, cyclosporine, methotrexate, cyclophosphamide, sirolimus)
Show all 13Show fewer
- Child C cirrhosis
- HIV
- Febrile neutropenia
- Combined at least two of the three following features:
- Fever(>37.5。C) refractory to at least 3 days of appropriate antibiotics or Fever relapsing after a period of defervescence of at least 48 hours while still receiving antibiotics
- Clinical signs and/or symptoms suggestive of invasive mycosis: pleuritic chest pain or physical finding of pleural rub, or one of the following symptoms of lower respiratory tract infection (new sputum secretions, dypsnea, or hemoptysis)
- Development of new pulmonary infiltrates on chest X-ray or HRCT
Who cannot join
- Patients who can't be cooperative
- Have bleeding tendency or coagulopathy (PLT<100K)
- Pulmonary lesion could not identify by chest ultrasonography
- Patients who do not have informed consent before the procedure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Hao-Chien Wang, 0972651872, haochienwang@gmail.com
About this study
Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic or have undergone solid organ or stem cell transplantation. However, early diagnosis of invasive aspergillosis is a challenge. Reiss and Lehmann first described the value of serum Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979. The availability of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA in 2003 for managing patients at risk of invasive aspergillosis because of the early detection of the GM antigen. In several studies so far the specificity of the serum galactomannan assay was greater than 85%; however, variable sensitivity from 29~100% was noted over years. In addition, low values and false-negative results are seen more often in nonneutropenic and solid organ transplantation patients as opposed to severely granulocytopenic patients .There are several factors that might explain the reported difference in the performance of antigen detection, including the biological factors and epidemiological factors.
In recent years, specimens of other body fluids are increasingly used for detection of Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid, cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity of the GM detection in various specimens still have considerably variation. Ultrasound-guided transthoracic aspirate is a safe and useful method for collecting specimens for accurate bacteriologic diagnosis of lung abscess and obstructive pneumonitis10. We also reported a study of diagnosis of pulmonary Cryptococosis by ultrasound guided percutaneous aspiration. We plan to perform a prospective single-center study to investigate the role of GM in the target organ (lung tissue/fluid) by using ultrasound-guided fine needle aspirate for early diagnosis invasive aspergillosis compared with the serum galactomannan.
Read the detailed description
Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic or have undergone solid organ or stem cell transplantation. However, early diagnosis of invasive aspergillosis is a challenge. Reiss and Lehmann first described the value of serum Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979. Galactomannan is a water-soluble, polysaccharide cell wall component which is released by Aspergillus during fungal growth after inhalation of Aspergillus conidia to the lung. The availability of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA in 2003 for managing patients at risk of invasive aspergillosis because of the early detection of the GM antigen. In several studies so far the specificity of the serum galactomannan assay was greater than 85%; however, variable sensitivity from 29~100% was noted over years. In addition, low values and false-negative results are seen more often in nonneutropenic and solid organ transplantation patients as opposed to severely granulocytopenic patients .There are several factors that might explain the reported difference in the performance of antigen detection, including the biological factors (non-neutropenic patients, prior exposure to antifungal agents, encapsulation abscess preventing GM leakage to the circulation, renal clearance,…etc.) and epidemiological factors (patient population, cut-off value, prevalence of infection…etc) .
In recent years, specimens of other body fluids are increasingly used for detection of Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid, cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity of the GM detection in various specimens still have considerably variation. Ultrasound-guided transthoracic aspirate is a safe and useful method for collecting specimens for accurate bacteriologic diagnosis of lung abscess and obstructive pneumonitis10. We also reported a study of diagnosis of pulmonary Cryptococosis by ultrasound guided percutaneous aspiration. We plan to perform a prospective single-center study to investigate the role of GM in the target organ (lung tissue/fluid) by using ultrasound-guided fine needle aspirate for early diagnosis invasive aspergillosis compared with the serum galactomannan.
- Conditions
- Immunocompromised
- Being tested
- Lung aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung aspirationProcedure or surgery
direct lung tissue Aspergillus galactomannan antigen detection from aspirate by ultrasound-guided fine needle aspiration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: Lung aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic rate of lung tissue Aspergillus galactomannan antigen detection compaired with serum Aspergillus galactomannan antigen detection
we will use echo-guide lung tissue aspiration to detect lung tissue Aspergillus galactomannan antigen compaired with conventional serum Aspergillus galactomannan antigen detection to early diagnose pulmonary aspergillosis
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startMar 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunocompromisedStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hao-Chien Wang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301755
- Sponsor's protocol ID
- 201002035R
- Status last verified
- Feb 2011
- First submitted
- 17 Mar 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Invasive Pulmonary Aspergillosis by Direct Lung Tissue Aspergillus Galactomannan Antigen Detection From Aspirate by Ultrasound-guided Fine Needle Aspiration
- ClinicalTrials.gov ID
- NCT01301755
- Acronym / sponsor ID
- 201002035R
- Conditions
- Immunocompromised
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 23 Feb 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.
Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic or have undergone solid organ or stem cell transplantation. However, early diagnosis of invasive aspergillosis is a challenge. Reiss and Lehmann first described the value of serum Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979. The availability of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA in 2003 for managing patients at risk of invasive aspergillosis because of the early detection of the GM antigen. In several studies so far the specificity of the serum galactomannan assay was greater than 85%; however, variable sensitivity from 29~100% was noted over years. In addition, low values and false-negative results are seen more often in nonneutropenic and solid organ transplantation patients as opposed to severely granulocytopenic patients .There are several factors that might explain the reported difference in the performance of antigen detection, including the biological factors and epidemiological factors.
In recent years, specimens of other body fluids are increasingly used for detection of Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid, cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity of the GM detection in various specimens still have considerably variation. Ultrasound-guided transthoracic aspirate is a safe and useful method for collecting specimens for accurate bacteriologic diagnosis of lung abscess and obstructive pneumonitis10. We also reported a study of diagnosis of pulmonary Cryptococosis by ultrasound guided percutaneous aspiration. We plan to perform a prospective single-center study to investigate the role of GM in the target organ (lung tissue/fluid) by using ultrasound-guided fine needle aspirate for early diagnosis invasive aspergillosis compared with the serum galactomannan.
Detailed description
Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic or have undergone solid organ or stem cell transplantation. However, early diagnosis of invasive aspergillosis is a challenge. Reiss and Lehmann first described the value of serum Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979. Galactomannan is a water-soluble, polysaccharide cell wall component which is released by Aspergillus during fungal growth after inhalation of Aspergillus conidia to the lung. The availability of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA in 2003 for managing patients at risk of invasive aspergillosis because of the early detection of the GM antigen. In several studies so far the specificity of the serum galactomannan assay was greater than 85%; however, variable sensitivity from 29~100% was noted over years. In addition, low values and false-negative results are seen more often in nonneutropenic and solid organ transplantation patients as opposed to severely granulocytopenic patients .There are several factors that might explain the reported difference in the performance of antigen detection, including the biological factors (non-neutropenic patients, prior exposure to antifungal agents, encapsulation abscess preventing GM leakage to the circulation, renal clearance,…etc.) and epidemiological factors (patient population, cut-off value, prevalence of infection…etc) .
In recent years, specimens of other body fluids are increasingly used for detection of Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid, cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity of the GM detection in various specimens still have considerably variation. Ultrasound-guided transthoracic aspirate is a safe and useful method for collecting specimens for accurate bacteriologic diagnosis of lung abscess and obstructive pneumonitis10. We also reported a study of diagnosis of pulmonary Cryptococosis by ultrasound guided percutaneous aspiration. We plan to perform a prospective single-center study to investigate the role of GM in the target organ (lung tissue/fluid) by using ultrasound-guided fine needle aspirate for early diagnosis invasive aspergillosis compared with the serum galactomannan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Lung aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- immunocompromised patients
Key inclusion criteria (13 listed)
- A hematologic malignancy, unless they were already treated with antifungals for a presumed or proven IA
- Cancer and receiving chemotherapy within the last 3 months before admission
- Solid organ transplant recipient
- Prolong steroid use
- Recipient of any other immunosuppressive treatment (tacrolimus, cyclosporine, methotrexate, cyclophosphamide, sirolimus)
Key exclusion criteria (4 listed)
- Patients who can't be cooperative
- Have bleeding tendency or coagulopathy (PLT<100K)
- Pulmonary lesion could not identify by chest ultrasonography
- Patients who do not have informed consent before the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung aspirationdirect lung tissue Aspergillus galactomannan antigen detection from aspirate by ultrasound-guided fine needle aspiration | Procedure or surgery | 1 |
Primary outcome
The diagnostic rate of lung tissue Aspergillus galactomannan antigen detection compaired with serum Aspergillus galactomannan antigen detection
Time frame: 3 weeks
we will use echo-guide lung tissue aspiration to detect lung tissue Aspergillus galactomannan antigen compaired with conventional serum Aspergillus galactomannan antigen detection to early diagnose pulmonary aspergillosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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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.
Hao-Chien Wang principal investigator
National Taiwan University Hospital
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 Immunocompromised, run by National Taiwan University Hospital at 1 site in Taiwan.
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 13 inclusion and 4 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 23 Feb 2011. 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 Taiwan. 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?
Contact Hao-Chien Wang (0972651872, haochienwang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic rate of lung tissue Aspergillus galactomannan antigen detection compaired with serum Aspergillus galactomannan antigen detection (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2011.