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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Laboratory testing	Microbiological analysis	All patients will receive the lab testing on bronchoscopy specimens

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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