Immunocompromised HostNCT00923832
Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis
An observational study of Immunocompromised Host and Invasive Pulmonary Fungal Infection, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Background: Fungal infections of the lung (pneumonia) can be caused by molds, such as Aspergillus and Zygomycetes, but these causes are often difficult for a doctor to diagnose. Early and accurate diagnosis of these infections can help doctors to select the correct medicines for proper treatment. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Immunocompromised Host, Invasive Pulmonary Fungal Infection, Invasive Pulmonary Aspergillosis
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2009to 23 Nov 2009
- 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 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients currently enrolled in any NIH IRB approved Clinical Center protocol or under treatment at the CNMC who are undergoing bronchoscopy or lung biopsy for diagnosis of possible invasive pulmonary aspergillosis or invasive pulmonary zygomycosis.
- Informed consent of the patient or the patient's legally authorized representative.
- Fulfillment of one or more of the following EORTC/MSG host criteria:
- History of neutropenia (ANC < 500/mm(3)) within the past 3 months temporally related to the onset of radiographic changes
- Receipt of an allogeneic HSCT
- Receipt of solid organ transplantation
Show all 18Show fewer
- Prolonged use of corticosteroids at an average minimum dose of 0.3 mg/kg/day prednisone equivalent for > 3 weeks
- Treatment with other recognized T-cell immune suppressants such as cyclosporine, TNF alpha blockers, specific monoclonal antibodies such as alemtuzumab, nucleoside analogues during the past 90 days
- Myelodysplastic syndrome
- Severe aplastic anemia
- Cushing's disease
- HIV/AIDS
- Primary immunodeficiencies (such as chronic granulomatous disease, severe combined immunodeficiency)
- The presence of one or more of the following signs on chest CT or radiograph:
- Dense well circumscribed lesions with or without a halo sign
- Air crescent sign
- Cavity
- Focal, segmental or lobar infiltrates
Who cannot join
- Interstitial or diffuse infiltrates on chest CT or radiograph
- Inability to provide informed consent
- Children weighing less than 10 kg
- Any other concomitant condition, which in the opinion of the investigator would place the patient at risk by participating in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Childrens National Medical Center
Washington D.C., District of Columbia
About this study
Background:
- Fungal infections of the lung (pneumonia) can be caused by molds, such as Aspergillus and Zygomycetes, but these causes are often difficult for a doctor to diagnose. Early and accurate diagnosis of these infections can help doctors to select the correct medicines for proper treatment.
- A number of methods are used to diagnose fungal pneumonia. Ones that are commonly used in clinical practice include radiographic imaging (chest X-rays and computed tomography (CT) scans), blood tests, and cultures taken from fluid from the lungs (broncho-alveolar lavage (BAL) fluid). Other new methods may improve the diagnosis of fungal pneumonias. These methods include tests that can detect DNA from the fungal germ in blood and BAL fluid of some patients with these infections.
Read more
Objectives:
- To help develop better and more accurate methods of diagnosing fungal lung infections.
- To detect fungal DNA and chemicals in the bloodstream and BAL fluid of immunocompromised patients with pneumonia.
Eligibility:
- Immunocompromised patients who are currently enrolled in another NIH protocol and who have a CT scan that shows a possible fungal infection of the lung.
Design:
- Researchers will review patients' existing medical records and CT scans, and current pneumonia treatment plans.
- Patients will provide blood and BAL samples for the duration of their treatment for pneumonia, as required by researchers. Additional CT scans will not be performed, except as part of existing treatment plans.
Read the detailed description
Background:
Invasive fungal infections are an important cause of infectious disease, morbidity and mortality in immunocompromised patients with cancer, hematopoietic stem cell transplantation, aplastic anemia, autoimmune diseases, and primary immune deficiencies.
Foremost among the more lethal of these infections are invasive pulmonary aspergillosis and zygomycosis. Early detection of these infections allows timely initiation of specific antifungal therapy, which may be life saving. However, early diagnosis of respiratory fungal infections is difficult, often leading to delay in therapy and inaccurate treatment.
The Immunocompromised Host Section has developed a series of sensitive and highly specific PCR assays for the detection of these life-threatening infections. We also have characterized the expression of cell wall derived biomarkers, (1-3)-Beta-D-glucan and galactomannan in vitro and in vivo. Laboratory animal studies indicate that these assays may complement current diagnostic modalities and allow for more accurate and earlier detection of invasive pulmonary fungal infections in immunocompromised patients.
Objectives:
The primary objective of this study is to improve the early diagnosis of invasive pulmonary aspergillosis and invasive pulmonary zygomycosis in immunocompromised patients through the addition of molecular biomarker detection methodology to the standard diagnostic systems used in clinical microbiology laboratories.
The secondary objectives are:
- To compare the diagnostic yield and analytical performance of the PCR, galactomannan and (1-3)-Beta-D-glucan to standard diagnostic systems.
- To evaluate the effect of different independent variables on expression of the aforementioned assays
- To characterize the variables that may contribute to therapeutic outcome (global response; survival)
- To characterize the use of these biomarkers in the context of EORTC/MSG definitions
- To identify genetic markers which may predispose patients to invasive fungal pulmonary infections.
Eligibility:
Immunocompromised patients currently enrolled in any NIH IRB approved Clinical Center protocol for the evaluation and/or treatment of his/her primary disease, or patients receiving treatment at the Children's National Medical Center (CNMC) who develop a pulmonary infiltrate radiologically compatible with invasive pulmonary aspergillosis or invasive pulmonary zygomycosis, by EORTC/MSG criteria.
Design:
This is a multi-center, prospective diagnostic interventional study.
Patients referred to the Clinical Center for evaluation and treatment in primary research protocols will be eligible for enrollment in this protocol at the Clinical Center. Patients meeting eligibility criteria may also be enrolled from the CNMC.
Patients who have compatible radiologic signs and are at risk for development of invasive pulmonary aspergillosis and invasive pulmonary zygomycosis will have specimens of bronchoalveolar lavage (BAL) fluid supernatant and /or tissue from lung biopsy when available, obtained for the measurement of diagnostic PCR for Aspergillus and Zygomycete identification, proteomics, cytokines and for the presence of galactomannan and (1-3)-Beta-D-glucan. The BAL will be performed only if clinically indicated as part of the patient's routine care of pneumonic infiltrates.
Blood will be obtained from patients meeting the eligibility requirements, regardless of whether they have had a BAL or lung tissue biopsy, to be submitted for the measurement of diagnostic PCR for Aspergillus and Zygomycete identification, proteomics, cytokines, presence of galactomannan and (1-3)-Beta-D-glucan and host genomics.
Digital copies of computer tomography (CT) images, that are part of routine care will utilized to reconstruct multi-dimensional volumetric images and correlate clinical and laboratory outcomes with the extent of lung volume involvement.
Background:
Invasive fungal infections are an important cause of infectious disease, morbidity and mortality in immunocompromised patients with cancer, hematopoietic stem cell transplantation, aplastic anemia, autoimmune diseases, and primary immune deficiencies.
Foremost among the more lethal of these infections are invasive pulmonary aspergillosis and zygomycosis. Early detection of these infections allows timely initiation of specific antifungal therapy, which may be life saving. However, early diagnosis of respiratory fungal infections is difficult, often leading to delay in therapy and inaccurate treatment.
The Immunocompromised Host Section has developed a series of sensitive and highly specific PCR assays for the detection of these life-threatening infections. We also have characterized the expression of cell wall derived biomarkers, (1-3)-Beta-D-glucan and galactomannan in vitro and in vivo. Laboratory animal studies indicate that these assays may complement current diagnostic modalities and allow for more accurate and earlier detection of invasive pulmonary fungal infections in immunocompromised patients.
Objectives:
The primary objective of this study is to improve the early diagnosis of invasive pulmonary aspergillosis and invasive pulmonary zygomycosis in immunocompromised patients through the addition of molecular biomarker detection methodology to the standard diagnostic systems used in clinical microbiology laboratories.
The secondary objectives are:
- To compare the diagnostic yield and analytical performance of the PCR, galactomannan and (1-3)-Beta-D-glucan to standard diagnostic systems.
- To evaluate the effect of different independent variables on expression of the aforementioned assays
- To characterize the variables that may contribute to therapeutic outcome (global response; survival)
- To characterize the use of these biomarkers in the context of EORTC/MSG definitions
- To identify genetic markers which may predispose patients to invasive fungal pulmonary infections.
Eligibility:
Immunocompromised patients currently enrolled in any NIH IRB approved Clinical Center protocol for the evaluation and/or treatment of his/her primary disease, or patients receiving treatment at the Children's National Medical Center (CNMC) who develop a pulmonary infiltrate radiologically compatible with invasive pulmonary aspergillosis or invasive pulmonary zygomycosis, by EORTS/MSG criteria.
Design:
This is a multi-center, prospective diagnostic interventional study.
Patients referred to the Clinical Center for evaluation and treatment in primary research protocols will be eligible for enrollment in this protocol at the Clinical Center. Patients meeting eligibility criteria may also be enrolled from the CNMC.
Patients who have compatible radiologic signs and are at risk for development of invasive pulmonary aspergillosis and invasive pulmonary zygomycosis will have specimens of bronchoalveolar lavage (BAL) fluid supernatant and /or tissue from lung biopsy when available, obtained for the measurement of diagnostic PCR for Aspergillus and Zygomycete identification, proteomics, cytokines and for the presence of galactomannan and (1-3)-Beta-D-glucan. The BAL will be performed only if clinically indicated as part of the patient's routine care of pneumonic infiltrates.
Blood will be obtained from patients meeting the eligibility requirements, regardless of whether they have had a BAL or lung tissue biopsy, to be submitted for the measurement of diagnostic PCR for Aspergillus and Zygomycete identification, proteomics, cytokines, presence of galactomannan and (1-3)-Beta-D-glucan and host genomics.
Digital copies of computer tomography (CT) images, that are part of routine care will be utilized to reconstruct multi-dimensional volumetric images and correlate clinical and laboratory outcomes with the extent of lung volume involvement.
- Conditions
- Immunocompromised Host, Invasive Pulmonary Fungal Infection, Invasive Pulmonary Aspergillosis, Invasive Pulmonary Zygomycosis
- Keywords
- Fungal Infections, PCR Assays, Cell Wall Derived Biomarkers, EORTC/MSG Definitions, Molecular Assays, Lung Fungal Infection, Invasive Pulmonary Fungal Infection, Invasive Pulmonary Aspegillosis, Invasive Pulmonary Zycomycosis
- Medical subject headings
- Invasive Pulmonary Aspergillosis, Mycoses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start30 Mar 2009
- Study completion23 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Immunocompromised HostStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923832
- Sponsor's protocol ID
- 090109
- Other IDs
- 09-C-0109
- Status last verified
- 23 Nov 2009
- First submitted
- 17 Jun 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Becker MJ, de Marie S, Willemse D, Verbrugh HA, Bakker-Woudenberg IA. Quantitative galactomannan detection is superior to PCR in diagnosing and monitoring invasive pulmonary aspergillosis in an experimental rat model. J Clin Microbiol. 2000 Apr;38(4):1434-8. doi: 10.1128/JCM.38.4.1434-1438.2000.
PubMed 10747121Cenci E, Mencacci A, Fe d'Ostiani C, Del Sero G, Mosci P, Montagnoli C, Bacci A, Romani L. Cytokine- and T helper-dependent lung mucosal immunity in mice with invasive pulmonary aspergillosis. J Infect Dis. 1998 Dec;178(6):1750-60. doi: 10.1086/314493.
PubMed 9815229Cortez KJ, Lyman CA, Kottilil S, Kim HS, Roilides E, Yang J, Fullmer B, Lempicki R, Walsh TJ. Functional genomics of innate host defense molecules in normal human monocytes in response to Aspergillus fumigatus. Infect Immun. 2006 Apr;74(4):2353-65. doi: 10.1128/IAI.74.4.2353-2365.2006.
PubMed 16552065
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis
- ClinicalTrials.gov ID
- NCT00923832
- Acronym / sponsor ID
- 090109
- Conditions
- Immunocompromised Host, Invasive Pulmonary Fungal Infection, Invasive Pulmonary Aspergillosis, Invasive Pulmonary Zygomycosis
- Keywords
- Fungal Infections, PCR Assays, Cell Wall Derived Biomarkers, EORTC/MSG Definitions, Molecular Assays, Lung Fungal Infection, Invasive Pulmonary Fungal Infection, Invasive Pulmonary Aspegillosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 30 Mar 2009
- Study completion
- 23 Nov 2009
- First posted
- 18 Jun 2009 (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.
Background:
- Fungal infections of the lung (pneumonia) can be caused by molds, such as Aspergillus and Zygomycetes, but these causes are often difficult for a doctor to diagnose. Early and accurate diagnosis of these infections can help doctors to select the correct medicines for proper treatment.
- A number of methods are used to diagnose fungal pneumonia. Ones that are commonly used in clinical practice include radiographic imaging (chest X-rays and computed tomography (CT) scans), blood tests, and cultures taken from fluid from the lungs (broncho-alveolar lavage (BAL) fluid). Other new methods may improve the diagnosis of fungal pneumonias. These methods include tests that can detect DNA from the fungal germ in blood and BAL fluid of some patients with these infections.
Objectives:
- To help develop better and more accurate methods of diagnosing fungal lung infections.
- To detect fungal DNA and chemicals in the bloodstream and BAL fluid of immunocompromised patients with pneumonia.
Eligibility:
- Immunocompromised patients who are currently enrolled in another NIH protocol and who have a CT scan that shows a possible fungal infection of the lung.
Design:
- Researchers will review patients' existing medical records and CT scans, and current pneumonia treatment plans.
- Patients will provide blood and BAL samples for the duration of their treatment for pneumonia, as required by researchers. Additional CT scans will not be performed, except as part of existing treatment plans.
Detailed description
Background:
Invasive fungal infections are an important cause of infectious disease, morbidity and mortality in immunocompromised patients with cancer, hematopoietic stem cell transplantation, aplastic anemia, autoimmune diseases, and primary immune deficiencies.
Foremost among the more lethal of these infections are invasive pulmonary aspergillosis and zygomycosis. Early detection of these infections allows timely initiation of specific antifungal therapy, which may be life saving. However, early diagnosis of respiratory fungal infections is difficult, often leading to delay in therapy and inaccurate treatment.
The Immunocompromised Host Section has developed a series of sensitive and highly specific PCR assays for the detection of these life-threatening infections. We also have characterized the expression of cell wall derived biomarkers, (1-3)-Beta-D-glucan and galactomannan in vitro and in vivo. Laboratory animal studies indicate that these assays may complement current diagnostic modalities and allow for more accurate and earlier detection of invasive pulmonary fungal infections in immunocompromised patients.
Objectives:
The primary objective of this study is to improve the early diagnosis of invasive pulmonary aspergillosis and invasive pulmonary zygomycosis in immunocompromised patients through the addition of molecular biomarker detection methodology to the standard diagnostic systems used in clinical microbiology laboratories.
The secondary objectives are:
- To compare the diagnostic yield and analytical performance of the PCR, galactomannan and (1-3)-Beta-D-glucan to standard diagnostic systems.
- To evaluate the effect of different independent variables on expression of the aforementioned assays
- To characterize the variables that may contribute to therapeutic outcome (global response; survival)
- To characterize the use of these biomarkers in the context of EORTC/MSG definitions
- To identify genetic markers which may predispose patients to invasive fungal pulmonary infections.
Eligibility:
Immunocompromised patients currently enrolled in any NIH IRB approved Clinical Center protocol for the evaluation and/or treatment of his/her primary disease, or patients receiving treatment at the Children's National Medical Center (CNMC) who develop a pulmonary infiltrate radiologically compatible with invasive pulmonary aspergillosis or invasive pulmonary zygomycosis, by EORTC/MSG criteria.
Design:
This is a multi-center, prospective diagnostic interventional study.
Patients referred to the Clinical Center for evaluation and treatment in primary research protocols will be eligible for enrollment in this protocol at the Clinical Center. Patients meeting eligibility criteria may also be enrolled from the CNMC.
Patients who have compatible radiologic signs and are at risk for development of invasive pulmonary aspergillosis and invasive pulmonary zygomycosis will have specimens of bronchoalveolar lavage (BAL) fluid supernatant and /or tissue from lung biopsy when available, obtained for the measurement of diagnostic PCR for Aspergillus and Zygomycete identification, proteomics, cytokines and for the presence of galactomannan and (1-3)-Beta-D-glucan. The BAL will be performed only if clinically indicated as part of the patient's routine care of pneumonic infiltrates.
Blood will be obtained from patients meeting the eligibility requirements, regardless of whether they have had a BAL or lung tissue biopsy, to be submitted for the measurement of diagnostic PCR for Aspergillus and Zygomycete identification, proteomics, cytokines, presence of galactomannan and (1-3)-Beta-D-glucan and host genomics.
Digital copies of computer tomography (CT) images, that are part of routine care will utilized to reconstruct multi-dimensional volumetric images and correlate clinical and laboratory outcomes with the extent of lung volume involvement.
Background:
Invasive fungal infections are an important cause of infectious disease, morbidity and mortality in immunocompromised patients with cancer, hematopoietic stem cell transplantation, aplastic anemia, autoimmune diseases, and primary immune deficiencies.
Foremost among the more lethal of these infections are invasive pulmonary aspergillosis and zygomycosis. Early detection of these infections allows timely initiation of specific antifungal therapy, which may be life saving. However, early diagnosis of respiratory fungal infections is difficult, often leading to delay in therapy and inaccurate treatment.
The Immunocompromised Host Section has developed a series of sensitive and highly specific PCR assays for the detection of these life-threatening infections. We also have characterized the expression of cell wall derived biomarkers, (1-3)-Beta-D-glucan and galactomannan in vitro and in vivo. Laboratory animal studies indicate that these assays may complement current diagnostic modalities and allow for more accurate and earlier detection of invasive pulmonary fungal infections in immunocompromised patients.
Objectives:
The primary objective of this study is to improve the early diagnosis of invasive pulmonary aspergillosis and invasive pulmonary zygomycosis in immunocompromised patients through the addition of molecular biomarker detection methodology to the standard diagnostic systems used in clinical microbiology laboratories.
The secondary objectives are:
- To compare the diagnostic yield and analytical performance of the PCR, galactomannan and (1-3)-Beta-D-glucan to standard diagnostic systems.
- To evaluate the effect of different independent variables on expression of the aforementioned assays
- To characterize the variables that may contribute to therapeutic outcome (global response; survival)
- To characterize the use of these biomarkers in the context of EORTC/MSG definitions
- To identify genetic markers which may predispose patients to invasive fungal pulmonary infections.
Eligibility:
Immunocompromised patients currently enrolled in any NIH IRB approved Clinical Center protocol for the evaluation and/or treatment of his/her primary disease, or patients receiving treatment at the Children's National Medical Center (CNMC) who develop a pulmonary infiltrate radiologically compatible with invasive pulmonary aspergillosis or invasive pulmonary zygomycosis, by EORTS/MSG criteria.
Design:
This is a multi-center, prospective diagnostic interventional study.
Patients referred to the Clinical Center for evaluation and treatment in primary research protocols will be eligible for enrollment in this protocol at the Clinical Center. Patients meeting eligibility criteria may also be enrolled from the CNMC.
Patients who have compatible radiologic signs and are at risk for development of invasive pulmonary aspergillosis and invasive pulmonary zygomycosis will have specimens of bronchoalveolar lavage (BAL) fluid supernatant and /or tissue from lung biopsy when available, obtained for the measurement of diagnostic PCR for Aspergillus and Zygomycete identification, proteomics, cytokines and for the presence of galactomannan and (1-3)-Beta-D-glucan. The BAL will be performed only if clinically indicated as part of the patient's routine care of pneumonic infiltrates.
Blood will be obtained from patients meeting the eligibility requirements, regardless of whether they have had a BAL or lung tissue biopsy, to be submitted for the measurement of diagnostic PCR for Aspergillus and Zygomycete identification, proteomics, cytokines, presence of galactomannan and (1-3)-Beta-D-glucan and host genomics.
Digital copies of computer tomography (CT) images, that are part of routine care will be utilized to reconstruct multi-dimensional volumetric images and correlate clinical and laboratory outcomes with the extent of lung volume involvement.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Patients currently enrolled in any NIH IRB approved Clinical Center protocol or under treatment at the CNMC who are undergoing bronchoscopy or lung biopsy for diagnosis of possible invasive pulmonary aspergillosis or invasive pulmonary zygomycosis.
- Informed consent of the patient or the patient's legally authorized representative.
- History of neutropenia (ANC < 500/mm(3)) within the past 3 months temporally related to the onset of radiographic changes
- Receipt of an allogeneic HSCT
- Receipt of solid organ transplantation
Key exclusion criteria (4 listed)
- Interstitial or diffuse infiltrates on chest CT or radiograph
- Inability to provide informed consent
- Children weighing less than 10 kg
- Any other concomitant condition, which in the opinion of the investigator would place the patient at risk by participating in the study
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 10747121Becker MJ, de Marie S, Willemse D, Verbrugh HA, Bakker-Woudenberg IA. Quantitative galactomannan detection is superior to PCR in diagnosing and monitoring invasive pulmonary aspergillosis in an experimental rat model. J Clin Microbiol. 2000 Apr;38(4):1434-8. doi: 10.1128/JCM.38.4.1434-1438.2000.
- Background: PubMed 9815229Cenci E, Mencacci A, Fe d'Ostiani C, Del Sero G, Mosci P, Montagnoli C, Bacci A, Romani L. Cytokine- and T helper-dependent lung mucosal immunity in mice with invasive pulmonary aspergillosis. J Infect Dis. 1998 Dec;178(6):1750-60. doi: 10.1086/314493.
- Background: PubMed 16552065Cortez KJ, Lyman CA, Kottilil S, Kim HS, Roilides E, Yang J, Fullmer B, Lempicki R, Walsh TJ. Functional genomics of innate host defense molecules in normal human monocytes in response to Aspergillus fumigatus. Infect Immun. 2006 Apr;74(4):2353-65. doi: 10.1128/IAI.74.4.2353-2365.2006.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunocompromised Host and Invasive Pulmonary Fungal Infection, run by National Cancer Institute (NCI) at 2 sites in United States.
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 18 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00923832, which also lists 3 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 2 Jul 2017.