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

Northside Hospital, Inc. logo

Northside Hospital, Inc.

Status

Completed

Conditions

Pulmonary Infiltrate New

Treatments

Other: Microbiological analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT01328873
NSH 909

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

49 participants in 1 patient group

Laboratory testing
Experimental group
Description:
All patients will receive the lab testing on bronchoscopy specimens
Treatment:
Other: Microbiological analysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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