Status:
COMPLETED
Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Immunocompromised Host
Invasive Pulmonary Fungal Infection
Eligibility:
All Genders
1-99 years
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 ...
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, aplast...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 30 2009
Trial Type :
OBSERVATIONAL
End Date :
November 23 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00923832
Start Date
March 30 2009
End Date
November 23 2009
Last Update
July 2 2017
Active Locations (2)
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1
Childrens National Medical Center
Washington D.C., District of Columbia, United States
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892