Expired Study
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Atlanta, Georgia 30342


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT01328873


Primary Contact:

Principal Investigator
H. Kent Holland, MD
Blood and Marrow Transplant Group of Georgia


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30342
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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