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| Name | Class |
|---|---|
| Blood and Marrow Transplant Group of Georgia | OTHER |
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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.
Proper diagnosis and prompt treatment favorably impacts survival in the post transplant setting, but is often difficult and frequently results in inappropriate or late therapy. Low yields may be linked with empiric antibody therapy begun prior to the procedure, delayed time to procedure, procedure technique, the presence of graft versus host disease (GVHD), neutropenia, and diffuse infiltrates (as opposed to localized infiltrates or focal masses and nodules). One recent study found that early FOBs (less than or equal to 4 days between detection of pulmonary infiltrates and FOB) were 2.5 times more likely to establish a diagnosis of pneumonia compared to late examinations. Delaying this procedure(greater than 5 days between detection of pulmonary infiltrates and FOB) was associated with drug resistant organisms, polymicrobial infections, and worsened patient prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laboratory testing | Experimental | All patients will receive the lab testing on bronchoscopy specimens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiological analysis | Other | Bronchoalveolar lavage (BAL) with subsequent testing for pathogens |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Positive Culture or Molecular Results After Brochoscopy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Positive CT Result | To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings. Patients were evaluated by changes on the CT and categorized as follows:
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Kent Holland, MD | Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19684637 | Background | 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. | |
| 17278083 | Background |
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Patients were excluded only if they refused to participate or required antibiotic changes within the 7 days prior to being approached for the study. An additional 2 pateints were considered screen failures for this study and did not proceed.
Recruitment period - May 2011 - Sept 2015 Patients were identified in either the outpatient clinic or inpatient BMT/Leukemia unit
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| ID | Title | Description |
|---|---|---|
| FG000 | Laboratory Testing | All patients will receive the lab testing on bronchoscopy specimens Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Laboratory Testing | All patients will receive the lab testing on bronchoscopy specimens Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Patients were treated in an adult center. All patients were over the age of 18. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Positive Culture or Molecular Results After Brochoscopy | 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. | Posted | Number | participants | 30 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laboratory Testing | All patients will receive the lab testing on bronchoscopy specimens Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Kent Holland, MD | Northside Hospital | 404-255-1930 | kholland@bmtga.com |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Number of Participants With Positive Bacterial Results by PCR | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | 24-48 hours |
| Number of Patients With Positive Fungal Results by PCR | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | 24-48 hours |
| Number of Participants With Positive Viral Results by PCR | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | 24-48 hours |
| Number of Participants With Positive Myocbacteria Results by Culture | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | 24-48 hours |
| 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(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available. |
| 19308034 | Background | 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. |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Patients With Positive CT Result | To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings. Patients were evaluated by changes on the CT and categorized as follows:
| Posted | Number | participants | 30 days |
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| Secondary | Number of Participants With Positive Bacterial Results by PCR | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | Posted | Number | participants | 24-48 hours |
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| Secondary | Number of Patients With Positive Fungal Results by PCR | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | Posted | Number | participants | 24-48 hours |
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| Secondary | Number of Participants With Positive Viral Results by PCR | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | Posted | Number | participants | 24-48 hours |
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| Secondary | Number of Participants With Positive Myocbacteria Results by Culture | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates | Posted | Number | participants | 24-48 hours |
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| 0 |
| 49 |
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| 49 |
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