Trial Outcomes & Findings for Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia (NCT NCT00319644)

Results Overview

We expect that 100-110 adult patients will have clinically suspected VAP over a 2-year period. We assume that 50 patients with suspected VAP will be randomized to mini-BAl, and 50 patients will be randomized to tracheal aspirate. We expect that patients randomized to tracheal aspirate group will receive an average of approximately 14 total days of antibiotics over their ICU stay. This study will have \>80% power to detect a difference of 4 days of antibiotics (i.e. average of 10 days in mini-BAL group) with a 7-day standard deviation in both groups (alpha error level 5%).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

It is theorized that patients randomized to the tracheal aspirate will receive an average of 15 days of antibiotics while patients randomized under the minibal arm will receive an average of 10 days of antibiotics

Results posted on

2012-11-16

Participant Flow

Study was a randomized, controlled trial of adult patients admitted to the trauma/surgical intensive care unit of San Francisco General Hospital and was conducted from 5/1/2005 to August 15, 2008

Adult patients with suspected VAP were randomized to the mini-BAL (MB) diagnostic group or the tracheal aspirate (TA) diagnostic group.

Participant milestones

Participant milestones
Measure	Tracheal Aspirates No intervention. Standard of care in ICU.	Minibal Arm Using Mini bronchoalveolar lavage
Overall Study STARTED	21	16
Overall Study COMPLETED	21	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Minibal Arm n=16 Participants Using Mini bronchoalveolar lavage	Tracheal Aspirates n=21 Participants No intervention. Standard of care in ICU.	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	49.38 years STANDARD_DEVIATION 16.3 • n=5 Participants	52.81 years STANDARD_DEVIATION 19.3 • n=7 Participants	51.09 years STANDARD_DEVIATION 27.45 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	21 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: It is theorized that patients randomized to the tracheal aspirate will receive an average of 15 days of antibiotics while patients randomized under the minibal arm will receive an average of 10 days of antibiotics

Population: Of the 37 adult critically ill patients, 21 belonged to the tracheal aspirate (TA) group and 16 patients were classified as mini-BAL (MB) group.

We expect that 100-110 adult patients will have clinically suspected VAP over a 2-year period. We assume that 50 patients with suspected VAP will be randomized to mini-BAl, and 50 patients will be randomized to tracheal aspirate. We expect that patients randomized to tracheal aspirate group will receive an average of approximately 14 total days of antibiotics over their ICU stay. This study will have \>80% power to detect a difference of 4 days of antibiotics (i.e. average of 10 days in mini-BAL group) with a 7-day standard deviation in both groups (alpha error level 5%).

Outcome measures

Outcome measures
Measure	Mini-BAL n=16 Participants BAL for quantitative culture as TA group.	Tracheal Aspirates n=21 Participants No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
Change in Antibiotic Usage or Exposure	11.87 days Standard Deviation 13.80	7.76 days Standard Deviation 1.06

PRIMARY outcome

Timeframe: 15 days

Population: Random

We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure

Outcome measures

Outcome measures
Measure	Mini-BAL n=16 Participants BAL for quantitative culture as TA group.	Tracheal Aspirates n=21 Participants No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
Antibiotics Exposure Days	4 days Standard Deviation 3.89	5.81 days Standard Deviation 6.95

Adverse Events

Minibal Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Tracheal Aspirates

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Minibal Arm n=16 participants at risk Using Mini bronchoalveolar lavage	Tracheal Aspirates n=21 participants at risk No intervention. Standard of care in ICU.
Respiratory, thoracic and mediastinal disorders Transient Desaturation	6.2% 1/16 • Number of events 1	0.00% 0/21
Psychiatric disorders Agitation	6.2% 1/16 • Number of events 1	0.00% 0/21

Additional Information

Julin Tang, MD

University of California, San Francisco

Phone: 415-206-5274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place