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

NCT00923832 | Completed

• 2 other identifiers: 09010909-C-0109
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.
• 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.

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

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 10747121 BACKGROUND

• Cenci 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.

  PMID: 9815229 BACKGROUND

• Cortez 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.

  PMID: 16552065 BACKGROUND

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis; Mycoses

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: March 30, 2009
• Study Completion: November 23, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-11-23

Locations

US (2)