Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis
This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923832
First received: June 17, 2009
Last updated: November 25, 2009
Last verified: November 2009
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Purpose
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.
| Condition |
|---|
|
Immunocompromised Host Invasive Pulmonary Fungal Infection Invasive Pulmonary Aspergillosis Invasive Pulmonary Zygomycosis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis |
Resource links provided by NLM:
Further study details as provided by National Institutes of Health Clinical Center (CC):
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | November 2009 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- INCLUSION CRITERIA:
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
- 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
EXCLUSION CRITERIA:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923832
Locations
| United States, District of Columbia | |
| Childrens National Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
Sponsors and Collaborators
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00923832 History of Changes |
| Other Study ID Numbers: | 090109, 09-C-0109 |
| Study First Received: | June 17, 2009 |
| Last Updated: | November 25, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
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 |
Additional relevant MeSH terms:
|
Aspergillosis Lung Diseases, Fungal Mycoses Zygomycosis Mucormycosis |
Invasive Pulmonary Aspergillosis Pulmonary Aspergillosis Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on June 17, 2013