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Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia (AAINTVAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
John Bini, Wright State University

Brief Summary:
The purpose of this study is to determine if administering inhaled antibiotics directly into the lungs in conjunction with intravenous (IV) antibiotics leads to better outcomes and decreased recurrence of ventilator associated pneumonia (VAP) when compared to IV antibiotics alone.

Condition or disease Intervention/treatment Phase
Pneumonia, Ventilator-Associated Drug: Aerosolized Tobramycin or Vancomycin Drug: Aerosolized Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Ventilator-free days [ Time Frame: 28 days ]
    number of days not on vent in first 28 days after randomization

  2. Intensive Care Unit (ICU) -free days in 28 days [ Time Frame: 28 days ]
    number of days not in ICU after initiation of therapy

  3. 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

  4. 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

  5. renal insufficiency [ Time Frame: 28 days ]
    patients who develop acute kidney injury after randomization

  6. 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

  7. emergence of resistant organisms [ Time Frame: 28 days ]
    patients with failure of therapy or persistence who grow resistant organisms after being treated initially

  8. number of antibiotic days [ Time Frame: 28 days ]
    total days antibiotics administered for pneumonia after randomization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical Pulmonary Infection Score (CPIS) greater than or equal to 6
  2. Intubated greater than or equal to 48 hours
  3. Screened for possible eligibility
  4. Bronchoscopy and bronchoalveolar lavage (BAL) or combicath performed
  5. Started on empiric intravenous (IV) and inhaled antibiotics after BAL for suspected ventilator associated pneumonia (VAP)
  6. > 104 Colony Forming Units (CFU) on BAL

Exclusion Criteria:

  1. <18 years of age
  2. Pregnant
  3. Human Immunodeficiency Virus (HIV) or on chronic immunosuppressants
  4. Absolute Neutrophil Count <1,000
  5. Allergy to vancomycin or tobramycin
  6. Anaphylaxis to penicillin
  7. Cystic Fibrosis
  8. Previous enrollment
  9. Creatinine >2 mg/dl or doubled within the previous 72 hours

Information from the National Library of Medicine

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


Contacts
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Contact: John K. Bini, MD 937-208-2552 DOSResearch@wrightstatephysicians.org
Contact: Priti Parikh, PhD 937-208-3767 priti.parikh@wright.edu

Locations
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United States, Ohio
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Linda Clark, MSN    937-208-2913      
Sponsors and Collaborators
Wright State University
Investigators
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Principal Investigator: John K. Bini, MD Wright State University
Study Director: Priti Parikh, PhD Wright State University

Publications:

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Responsible Party: John Bini, Assistant Professor of Surgery, Wright State University
ClinicalTrials.gov Identifier: NCT02478710    
Other Study ID Numbers: AAINTVAP
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Anti-Bacterial Agents
Vancomycin
Tobramycin
Anti-Infective Agents