Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Inva… (NCT00923832) | Clinical Trial Compass
CompletedNot Applicable
Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis
United StatesStarted 2009-03-30
Plain-language 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.
Who can participate
Age range
1 Year – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
A…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.