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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01328873
• Other study ID #: NSH 909
• Status: Active, not recruiting
• Phase: N/A
• First received: March 1, 2011
• Last updated: July 6, 2016
• Start date: March 2011
• Est. completion date: December 2016

Study information

• 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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Pulmonary Infiltrate New
• Signs and Symptoms, Respiratory

Intervention

Other:
• Microbiological analysis
Bronchoalveolar lavage (BAL) with subsequent testing for pathogens

Locations

Country	Name	City	State
United States	Northside Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Northside Hospital, Inc.	Blood and Marrow Transplant Group of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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