Fiberoptic Bronchoscopy (FOB) in Hematopoietic Stem Cell Transplant (HSCT) and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Diagnostic Yield [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Comparison of diagnostic yield to historical data [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Therapeutic changes from BAL [ Time Frame: 30 days ] [ Designated as safety issue: No ]To document therapeutic changes that occurred as a result of FOB findings
- Correlation of infiltrates with microbiological findings [ Time Frame: 30 days ] [ Designated as safety issue: No ]To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings
- Description of microbiological findings [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
- Comparison of new testing vs standard of care tests [ Time Frame: 30 days ] [ Designated as safety issue: No ]To compare the findings of the new PCR-based tests to that of current standard of care tests.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Laboratory testing
All patients will receive the lab testing on bronchoscopy specimens
Other: Microbiological analysis
Bronchoalveolar lavage (BAL) with subsequent testing for pathogens
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328873
|Contact: H. Kent Holland, MDfirstname.lastname@example.org|
|Contact: Melissa Sanacore, PharmDemail@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|Contact: Melissa Sanacore, PharmD 404-845-5604 firstname.lastname@example.org|
|Contact: Stacey Brown, BA 404-851-8238 email@example.com|
|Sub-Investigator: Melissa Sanacore, PharmD|
|Principal Investigator:||H. Kent Holland, MD||Blood and Marrow Transplant Group of Georgia|