Fiberoptic Bronchoscopy (FOB) in Hematopoietic Stem Cell Transplant (HSCT) and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates

• 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.

• 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 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 SOC 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.

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.

• 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. Epub 2009 Aug 17.
• 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. No abstract available.
• 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. Epub 2009 Mar 23.

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