Clinical trial NCT01328873: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Infiltrate New
Keywords: Pulmonary infiltrates
stem cell transplant
leukemia
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
Collaborators: name: Blood and Marrow Transplant Group of Georgia
First posted: 2011-04-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Positive Culture or Molecular Results After Brochoscopy
timeFrame: 30 days
Secondary outcomes:
measure: Number of Patients With Positive CT Result
timeFrame: 30 days
measure: Number of Participants With Positive Bacterial Results by PCR
timeFrame: 24-48 hours
measure: Number of Patients With Positive Fungal Results by PCR
timeFrame: 24-48 hours
measure: Number of Participants With Positive Viral Results by PCR
timeFrame: 24-48 hours
measure: Number of Participants With Positive Myocbacteria Results by Culture
timeFrame: 24-48 hours
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: Blood and Marrow Transplant Group of Georgia
name: H. Kent Holland, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.