Trial Outcomes & Findings for FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates (NCT NCT01328873)

Last Updated: 2017-07-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

30 days

Results posted on

2017-07-11

Participant Flow

Recruitment period - May 2011 - Sept 2015 Patients were identified in either the outpatient clinic or inpatient BMT/Leukemia unit

Patients were excluded only if they refused to participate or required antibiotic changes within the 7 days prior to being approached for the study. An additional 2 pateints were considered screen failures for this study and did not proceed.

Participant milestones

Participant milestones
Measure	Laboratory Testing All patients will receive the lab testing on bronchoscopy specimens Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laboratory Testing n=49 Participants All patients will receive the lab testing on bronchoscopy specimens Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=93 Participants
Age, Categorical >=65 years	13 Participants n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	31 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants
Race (NIH/OMB) White	39 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	49 participants n=93 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	All Patients Will Receive Lab Testing on Bronchoscopy Specimen n=49 Participants
Number of Patients With Positive Culture or Molecular Results After Brochoscopy	40 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	All Patients Will Receive Lab Testing on Bronchoscopy Specimen n=49 Participants
Number of Patients With Positive CT Result	49 participants

SECONDARY outcome

Timeframe: 24-48 hours

To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates

Outcome measures

Outcome measures
Measure	All Patients Will Receive Lab Testing on Bronchoscopy Specimen n=49 Participants
Number of Participants With Positive Bacterial Results by PCR	2 participants

SECONDARY outcome

Timeframe: 24-48 hours

To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates

Outcome measures

Outcome measures
Measure	All Patients Will Receive Lab Testing on Bronchoscopy Specimen n=49 Participants
Number of Patients With Positive Fungal Results by PCR	4 participants

SECONDARY outcome

Timeframe: 24-48 hours

To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates

Outcome measures

Outcome measures
Measure	All Patients Will Receive Lab Testing on Bronchoscopy Specimen n=49 Participants
Number of Participants With Positive Viral Results by PCR	48 participants

SECONDARY outcome

Timeframe: 24-48 hours

To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates

Outcome measures

Outcome measures
Measure	All Patients Will Receive Lab Testing on Bronchoscopy Specimen n=49 Participants
Number of Participants With Positive Myocbacteria Results by Culture	2 participants

Adverse Events

Laboratory Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

H. Kent Holland, MD

Northside Hospital

Phone: 404-255-1930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications will need prior written consent from sponsor.
Publication restrictions are in place

Restriction type: OTHER