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FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328873
First Posted: April 5, 2011
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.
  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: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients With Positive Culture or Molecular Results After Brochoscopy [ Time Frame: 30 days ]
    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 [ Time Frame: 30 days ]

    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:

    1. Air space
    2. ground glass/reticular nodular
    3. nodular/cavitary
    4. single patchy infiltrate

  • Number of Participants With Positive Bacterial Results by PCR [ Time Frame: 24-48 hours ]
    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 [ Time Frame: 24-48 hours ]
    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 [ Time Frame: 24-48 hours ]
    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 [ Time Frame: 24-48 hours ]
    To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates


Enrollment: 49
Study Start Date: March 2011
Study Completion Date: April 2017
Primary Completion Date: October 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328873


Locations
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
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

Publications:
Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01328873     History of Changes
Other Study ID Numbers: NSH 909
First Submitted: March 1, 2011
First Posted: April 5, 2011
Results First Submitted: October 5, 2016
Results First Posted: April 26, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Northside Hospital, Inc.:
Pulmonary infiltrates
stem cell transplant
leukemia

Additional relevant MeSH terms:
Leukemia
Signs and Symptoms, Respiratory
Neoplasms by Histologic Type
Neoplasms
Signs and Symptoms