Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia (AAINTVAP)
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|ClinicalTrials.gov Identifier: NCT02478710|
Recruitment Status : Unknown
Verified September 2016 by John Bini, Wright State University.
Recruitment status was: Recruiting
First Posted : June 23, 2015
Last Update Posted : September 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia, Ventilator-Associated||Drug: Aerosolized Tobramycin or Vancomycin Drug: Aerosolized Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia: A Pilot Study|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Placebo Comparator: Aerosolized Placebo
Placebo tobramycin 0.5 mL 0.9% normal saline q.12h. Placebo vancomycin 0.5 mL 0.9% normal saline q.8h.
Drug: Aerosolized Placebo
Placebo tobramycin: 5 ml 0.9% normal saline q. 12h. Placebo vancomycin: 5m 0.9% normal saline q. 8 hr.
Other Name: Normal saline solution
Experimental: Aerosolized Tobramycin or Vancomycin
Aerosolized tobramycin 300 mg diluted in 5 mL 0.9% normal saline q.12h. Aerosolized vancomycin 125 mg diluted in 5 mL 0.9% normal saline q.8h.
Drug: Aerosolized Tobramycin or Vancomycin
Tobramycin: 300 mg diluted in 5 mL of 0.9% normal saline q.12h. Vancomycin: 125 mg diluted in 5 mL 0.9% normal saline q.8h.
Other Name: Tobi, Tobrex; Vancocin
- Recurrence of pneumonia [ Time Frame: 9-21 days after initiating antibiotic therapy ]Recurrence after a second bronchoalveolar lavage (BAL) reveals at least one bacterial species growing at concentrations of greater than 10 to the fourth power organisms during the time period of 9-21 days after initiating therapy.
- Persistence of pneumonia [ Time Frame: 8 days after initiation of therapy for pneumonia ]Persistence will be defined as the need to continue antibiotic therapy for greater than 7 days.
- Ventilator-free days [ Time Frame: 28 days ]number of days not on vent in first 28 days after randomization
- Intensive Care Unit (ICU) -free days in 28 days [ Time Frame: 28 days ]number of days not in ICU after initiation of therapy
- 28-day ICU mortality [ Time Frame: 28 days ]number of patients treated in each arm who die in ICU within 28 days of initiation of therapy
- 28-day overall mortality [ Time Frame: 28 days ]number of patients treated in each arm who die in the hospital within 28 days of initiation of therapy
- renal insufficiency [ Time Frame: 28 days ]patients who develop acute kidney injury after randomization
- multiple organ dysfunction score at randomization and on day 7 of aerosolized antibiotics/placebo treatment [ Time Frame: 7 days ]multiple organ dysfunction score calculated at randomization and on day 7 of treatment
- emergence of resistant organisms [ Time Frame: 28 days ]patients with failure of therapy or persistence who grow resistant organisms after being treated initially
- number of antibiotic days [ Time Frame: 28 days ]total days antibiotics administered for pneumonia after randomization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478710
|Contact: John K. Bini, MD||937-208-2552||DOSResearch@wrightstatephysicians.org|
|Contact: Priti Parikh, PhDemail@example.com|
|United States, Ohio|
|Miami Valley Hospital||Recruiting|
|Dayton, Ohio, United States, 45409|
|Contact: Linda Clark, MSN 937-208-2913|
|Principal Investigator:||John K. Bini, MD||Wright State University|
|Study Director:||Priti Parikh, PhD||Wright State University|