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

NCT01328873 | Completed Results

• 1 other identifier: NSH 909
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Infiltrate New

Keywords

Pulmonary infiltrates; stem cell transplant; leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (5)

• Number of Patients With Positive CT Result

  30 days

• Number of Participants With Positive Bacterial Results by PCR

  24-48 hours

• Number of Patients With Positive Fungal Results by PCR

  24-48 hours

• Number of Participants With Positive Viral Results by PCR

  24-48 hours

• Number of Participants With Positive Myocbacteria Results by Culture

  24-48 hours

Study Arms (1)

Laboratory testing

EXPERIMENTAL

All patients will receive the lab testing on bronchoscopy specimens

Other: Microbiological analysis

Interventions

Microbiological analysis OTHER

Bronchoalveolar lavage (BAL) with subsequent testing for pathogens

Laboratory testing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northside Hospital, Inc.: lead
• Blood and Marrow Transplant Group of Georgia: collaborator

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Related Publications (3)

• 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.

  PMID: 19684637 BACKGROUND

• 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.

  PMID: 17278083 BACKGROUND

• 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.

  PMID: 19308034 BACKGROUND

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: H. Kent Holland, MD
• Organization: Northside Hospital

kholland@bmtga.com

404-255-1930

Study Officials

• H. Kent Holland, MD

  Blood and Marrow Transplant Group of Georgia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: April 5, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2017
• Last Updated: July 11, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)