N/A
N=49
FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
Pulmonary Infiltrate New
Bottom Line
View on ClinicalTrials.gov: NCT01328873 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Patients With Positive Culture or Molecular Results After Brochoscopy — 40 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Microbiological analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northside Hospital, Inc.
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Positive Culture or Molecular Results After Brochoscopy |
40 | — |
| SECONDARY Number of Patients With Positive CT Result |
49 | — |
| SECONDARY Number of Participants With Positive Bacterial Results by PCR |
2 | — |
| SECONDARY Number of Patients With Positive Fungal Results by PCR |
4 | — |
| SECONDARY Number of Participants With Positive Viral Results by PCR |
48 | — |
| SECONDARY Number of Participants With Positive Myocbacteria Results by Culture |
2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01328873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.