Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00923832

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:

MedlinePlus related topics: Aspergillosis Fungal Infections Molds Pneumonia

U.S. FDA Resources

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

National Cancer Institute (NCI)

More Information

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.

Cenci E, Mencacci A, Fè 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.

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.

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 February 09, 2012