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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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Pulmonary Infiltrate New

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Diagnostic Yield

Outcome Description:

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.

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

H. Kent Holland, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Blood and Marrow Transplant Group of Georgia

Authority:

United States: Institutional Review Board

Study ID:

NSH 909

NCT ID:

NCT01328873

Start Date:

March 2011

Completion Date:

December 2014

Related Keywords:

  • Pulmonary Infiltrate New
  • Pulmonary infiltrates
  • stem cell transplant
  • leukemia
  • Leukemia
  • Signs and Symptoms, Respiratory
  • Lung Diseases, Interstitial

Name

Location

Northside HospitalAtlanta, Georgia  30342