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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00319644
Other study ID # 27831-01
Secondary ID
Status Completed
Phase N/A
First received April 27, 2006
Last updated October 16, 2012
Start date May 2006
Est. completion date December 2008

Study information

Verified date October 2012
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The proposed study will evaluate adult patients admitted to the medical or surgical intensive care units (ICUs) at San Francisco General Hospital (SFGH). On admission, patients will be randomized in a 1:1 manner to the mini-bronchoalveolar lavage (BAL) quantitative culture arm in the setting of suspected ventilator-associated pneumonia (VAP) versus the tracheal aspirate culture arm, which is the current test available at SFGH.


Description:

Patients will be randomized to either Mini-Bal or tracheal aspirate then samples will be taken to the lab for culture. Comparative analysis will then be performed based upon lab results.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All adult patients (> age 18) admitted to 5E, 5R, and 4E intensive care units and are on the ventilator for greater than 48 hours and expected to remain on the ventilator for awhile

- Study procedures would be performed only in patients clinically suspected of having VAP.

Exclusion Criteria:

- Severe respiratory distress at the time of suspected VAP defined by:

- FiO2 = 0.7

- PEEP = 12

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Device:
Bronchoalveolar lavage
Using catheter to obtain respiratory sample

Locations

Country Name City State
United States San Francisco General Hospital San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Antibiotic Usage or Exposure 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%). 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 No
Primary Antibiotics Exposure Days We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure 15 days No
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