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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northside Hospital, Inc.
Sponsor:
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT01328873
First received: March 1, 2011
Last updated: October 7, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Pulmonary Infiltrate New
Other: Microbiological analysis

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Northside Hospital, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Arms Assigned Interventions
Experimental: Laboratory testing
All patients will receive the lab testing on bronchoscopy specimens
Other: Microbiological analysis
Bronchoalveolar lavage (BAL) with subsequent testing for pathogens

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328873

Contacts
Contact: H. Kent Holland, MD 404-255-1930 bmtga@aol.com
Contact: Melissa Sanacore, PharmD 404-845-5604 melissa.sanacore@northside.com

Locations
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Melissa Sanacore, PharmD    404-845-5604    melissa.sanacore@northside.com   
Contact: Stacey Brown, BA    404-851-8238    stacey.brown@northside.com   
Sub-Investigator: Melissa Sanacore, PharmD         
Sponsors and Collaborators
Northside Hospital, Inc.
Blood and Marrow Transplant Group of Georgia
Investigators
Principal Investigator: H. Kent Holland, MD Blood and Marrow Transplant Group of Georgia
  More Information