Pulmonary Infiltrate New
Conditions
Keywords
Pulmonary infiltrates, stem cell transplant, leukemia
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.
Interventions
Bronchoalveolar lavage (BAL) with subsequent testing for pathogens
Sponsors
Blood and Marrow Transplant Group of Georgia
Northside Hospital, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Positive Culture or Molecular Results After Brochoscopy | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Positive CT Result | 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 | 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 | 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 | 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 | 24-48 hours | To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates |
Countries
United States
Participant flow
Recruitment details
Recruitment period - May 2011 - Sept 2015 Patients were identified in either the outpatient clinic or inpatient BMT/Leukemia unit
Pre-assignment details
Patients were excluded only if they refused to participate or required antibiotic changes within the 7 days prior to being approached for the study. An additional 2 pateints were considered screen failures for this study and did not proceed.
Participants by arm
| Arm | Count |
|---|---|
| Laboratory Testing All patients will receive the lab testing on bronchoscopy specimens
Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Laboratory Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
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.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Will Receive Lab Testing on Bronchoscopy Specimen | Number of Patients With Positive Culture or Molecular Results After Brochoscopy | 40 participants |
Secondary
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
Time frame: 24-48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Will Receive Lab Testing on Bronchoscopy Specimen | Number of Participants With Positive Bacterial Results by PCR | 2 participants |
Secondary
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
Time frame: 24-48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Will Receive Lab Testing on Bronchoscopy Specimen | Number of Participants With Positive Myocbacteria Results by Culture | 2 participants |
Secondary
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
Time frame: 24-48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Will Receive Lab Testing on Bronchoscopy Specimen | Number of Participants With Positive Viral Results by PCR | 48 participants |
Secondary
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: 1. Air space 2. ground glass/reticular nodular 3. nodular/cavitary 4. single patchy infiltrate
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Will Receive Lab Testing on Bronchoscopy Specimen | Number of Patients With Positive CT Result | 49 participants |
Secondary
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
Time frame: 24-48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Will Receive Lab Testing on Bronchoscopy Specimen | Number of Patients With Positive Fungal Results by PCR | 4 participants |