This trial is active, not recruiting.

Condition pulmonary infiltrate new
Treatment microbiological analysis
Sponsor Northside Hospital, Inc.
Collaborator Blood and Marrow Transplant Group of Georgia
Start date March 2011
End date October 2015
Trial size 100 participants
Trial identifier NCT01328873, NSH 909


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
All patients will receive the lab testing on bronchoscopy specimens
microbiological analysis
Bronchoalveolar lavage (BAL) with subsequent testing for pathogens

Primary Outcomes

Diagnostic Yield
time frame: 30 days

Secondary Outcomes

Comparison of diagnostic yield to historical data
time frame: 30 days
Therapeutic changes from BAL
time frame: 30 days
Correlation of infiltrates with microbiological findings
time frame: 30 days
Description of microbiological findings
time frame: 24-48 hours
Comparison of new testing vs standard of care tests
time frame: 30 days

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title A Prospective Assessment of the Diagnostic Utility of Emerging Laboratory Assessments Used in Conjunction With Fiberoptic Bronchoscopy (FOB) in Hematopoietic Stem Cell Transplant (HSCT) and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
Principal investigator H. Kent Holland, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Northside Hospital, Inc..