FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
Primary Purpose
Pulmonary Infiltrate New
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microbiological analysis
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Infiltrate New focused on measuring Pulmonary infiltrates, stem cell transplant, leukemia
Eligibility 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
Sites / Locations
- Northside Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laboratory testing
Arm Description
All patients will receive the lab testing on bronchoscopy specimens
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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:
Air space
ground glass/reticular nodular
nodular/cavitary
single patchy infiltrate
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
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
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
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
Full Information
NCT ID
NCT01328873
First Posted
March 1, 2011
Last Updated
June 8, 2017
Sponsor
Northside Hospital, Inc.
Collaborators
Blood and Marrow Transplant Group of Georgia
1. Study Identification
Unique Protocol Identification Number
NCT01328873
Brief Title
FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
Official Title
A Prospective Assessment of the Diagnostic Utility of Emerging Laboratory Assessments Used in Conjunction With FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northside Hospital, Inc.
Collaborators
Blood and Marrow Transplant Group of Georgia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Infiltrate New
Keywords
Pulmonary infiltrates, stem cell transplant, leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laboratory testing
Arm Type
Experimental
Arm Description
All patients will receive the lab testing on bronchoscopy specimens
Intervention Type
Other
Intervention Name(s)
Microbiological analysis
Intervention Description
Bronchoalveolar lavage (BAL) with subsequent testing for pathogens
Primary Outcome Measure Information:
Title
Number of Patients With Positive Culture or Molecular Results After Brochoscopy
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of Patients With Positive CT Result
Description
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:
Air space
ground glass/reticular nodular
nodular/cavitary
single patchy infiltrate
Time Frame
30 days
Title
Number of Participants With Positive Bacterial Results by PCR
Description
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
Time Frame
24-48 hours
Title
Number of Patients With Positive Fungal Results by PCR
Description
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
Time Frame
24-48 hours
Title
Number of Participants With Positive Viral Results by PCR
Description
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
Time Frame
24-48 hours
Title
Number of Participants With Positive Myocbacteria Results by Culture
Description
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
Time Frame
24-48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Kent Holland, MD
Organizational Affiliation
Blood and Marrow Transplant Group of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19684637
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.
Results Reference
background
PubMed Identifier
17278083
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(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.
Results Reference
background
PubMed Identifier
19308034
Citation
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.
Results Reference
background
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FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
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