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Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis

This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: June 17, 2009
Last updated: January 24, 2017
Last verified: November 23, 2009


  • 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.


  • 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.


- 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.


  • 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.

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 30, 2009
Estimated Study Completion Date: November 23, 2009
  Show Detailed Description


Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00923832

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
National Cancer Institute (NCI)
  More Information

Publications: Identifier: NCT00923832     History of Changes
Other Study ID Numbers: 090109
Study First Received: June 17, 2009
Last Updated: January 24, 2017

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:
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on June 23, 2017