Pulmonary Infiltrate New Clinical Trial
Official title:
A Prospective Assessment of the Diagnostic Utility of Emerging Laboratory Assessments Used in Conjunction With Fiberoptic Bronchoscopy (FOB) in Hematopoietic Stem Cell Transplant (HSCT) and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
| Verified date | July 2016 |
| Source | Northside Hospital, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant
(HSCT) and leukemia patients. Bronchoalveolar lavage (BAL) is frequently used to evaluate
new pulmonary infiltrates in this population, however utility is limited by a historically
low diagnostic yield for infection.
In an effort to improve diagnostic yields, this study will complete a Fiberoptic
Bronchoscopy (FOB) within 8 hours of radiographic documentation of pulmonary infiltrates,
prior to initiating new antibiotic therapy. To further improve detection of microbiological
pathogens, the study will utilize PCR testing with rapid turnaround time to detect atypical
pneumonia (M pneumoniae, C. Pneumonia, Legionella species, and respiratory viruses) and
aspergillosis.
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Autologous or allogeneic stem cell patients with new acute respiratory symptoms or pulmonary infiltrates - leukemia patients with new acute respiratory symptoms or pulmonary infiltrates thought to be unrelated to disease Exclusion Criteria: - Patients unwilling to undergo FOB - Patients unable to undergo FOB due to clinical status - Patients unable to undergo FOB within 8 hours of radiographic report of pneumonia - Patients unable to wait until completion of FOB to implement antibiotic changes - Adults unable to provide informed consent |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Northside Hospital | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Northside Hospital, Inc. | Blood and Marrow Transplant Group of Georgia |
United States,
Hardak E, Yigla M, Avivi I, Fruchter O, Sprecher H, Oren I. Impact of PCR-based diagnosis of invasive pulmonary aspergillosis on clinical outcome. Bone Marrow Transplant. 2009 Nov;44(9):595-9. doi: 10.1038/bmt.2009.65. Epub 2009 Mar 23. — View Citation
Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2:S27-72. — View Citation
Shannon VR, Andersson BS, Lei X, Champlin RE, Kontoyiannis DP. Utility of early versus late fiberoptic bronchoscopy in the evaluation of new pulmonary infiltrates following hematopoietic stem cell transplantation. Bone Marrow Transplant. 2010 Apr;45(4):647-55. doi: 10.1038/bmt.2009.203. Epub 2009 Aug 17. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnostic Yield | 1.1 To determine the diagnostic yield related to fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in hematopoietic stem cell transplant (HSCT) and leukemia patients with acute respiratory symptoms and pulmonary infiltrates utilizing both current standard of care microbiology testing and emerging molecular genetic laboratory assessments. | 30 days | No |
| Secondary | Comparison of diagnostic yield to historical data | To compare the diagnostic yield using the combination of standard of care microbiology testing and emerging molecular genetic microbiology polymersase chain reaction (PCR)/assay testing to our prospectively collected historical data obtained at our institution. | 30 days | No |
| Secondary | Therapeutic changes from BAL | To document therapeutic changes that occurred as a result of FOB findings | 30 days | No |
| Secondary | Correlation of infiltrates with microbiological findings | To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings | 30 days | No |
| Secondary | Description of microbiological findings | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | 24-48 hours | No |
| Secondary | Comparison of new testing vs standard of care tests | To compare the findings of the new PCR-based tests to that of current standard of care tests. | 30 days | No |