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Decreasing Antibiotic Use in Infants With Suspected Ventilator-associated Infection (VAIN2)

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ClinicalTrials.gov Identifier: NCT03041207
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
This is a prospective study with three specific aims: (1) To convene a consensus conference to develop a guideline for antibiotic use in infants (age < 3 yrs) with suspected ventilator-associated infection; (2) To evaluate outcomes before and after implementation of the antibiotic guideline; (3) To evaluate changes in the tracheal microbiome over the course of mechanical ventilation

Condition or disease Intervention/treatment
Ventilator Associated Pneumonia Nosocomial Infections in Children Microbial Colonization Behavioral: Development and implementation of an antibiotic guideline

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Study Type : Observational
Actual Enrollment : 555 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decreasing Antibiotic Use in Infants With Suspected Ventilator-associated Infection
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Pre-antibiotic guideline
Infants for whom antibiotics have been initiated for suspected ventilator-associated infection prior to the implementation of the antibiotic guideline
Behavioral: Development and implementation of an antibiotic guideline
A consensus conference will develop and then implement a guideline for stopping vs. continuing antibiotics in infants with suspected ventilator-associated infection

After antibiotic guideline implementation
Infants for whom antibiotics have been initiated for suspected ventilator-associated infection after the implementation of the antibiotic guideline
Behavioral: Development and implementation of an antibiotic guideline
A consensus conference will develop and then implement a guideline for stopping vs. continuing antibiotics in infants with suspected ventilator-associated infection

Microbiome Study Group
Infants intubated and anticipated to require mechanical ventilation for at least several days



Primary Outcome Measures :
  1. Pediatric ICU-free days at 28 days [ Time Frame: 28 days after study enrollment ]
    28 - number of days in PICU (death = 0 free days)


Secondary Outcome Measures :
  1. Antibiotic days in PICU [ Time Frame: 28 days after study enrollment ]
    total number of antibiotic days with each antibiotic on each day = 1 antibiotic day (e.g., 3 antibiotics in one day = 3 antibiotic days)

  2. Ventilator-free days at 28 days [ Time Frame: 28 days after study enrollment ]
    28 - days on mechanical ventilation in PICU (death = 0 free days)

  3. Infection and sepsis episodes [ Time Frame: 28 days after study enrollment ]
    The number of infection and/or sepsis episodes after study enrollment



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants 0 - 3 years of age who have undergone a tracheal aspirate culture for suspected ventilator-associated infection and have had antibiotics initiated at that time.
Criteria

Inclusion Criteria:

  • Age newborn -- 3 years in the Pediatric ICU
  • on invasive mechanical ventilation > 48 hours
  • evaluation for ventilator-associated infection that includes respiratory secretion cultures and microscopic evaluation of the gram-stained specimen
  • antibiotics initiated for suspected ventilator-associated or other infection

Exclusion Criteria:

  • Immune compromise --Other positive cultures (blood, urine, etc.) for which antibiotic continuation is appropriate

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): NCT03041207


  Show 23 Study Locations
Sponsors and Collaborators
Virginia Commonwealth University
The Gerber Foundation
Investigators
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Principal Investigator: Douglas F Willson, MD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03041207     History of Changes
Other Study ID Numbers: HM20009140
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
ventilator associated infection
ventilator associated pneumonia
ventilator associated tracheitis
Lower respiratory infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents