Ventilator Associated PneumoniaBrighT STARNCT04987840
A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children
An observational study of Ventilator Associated Pneumonia and Tracheobronchitis, run by Johns Hopkins University at 8 sites in United States.
Trial summary
The objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilator Associated Pneumonia, Tracheobronchitis
- How many people
- 15 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 May 2021to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ICU patient populations from units that develop and implement a quality improvement program to reduce respiratory culture use
Who may be able to join
- Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs
Who cannot join
- Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Dell Children's Medical Center
Austin, Texas, 78723
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Boston Children's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44106
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Children's Minnesota Hospital
Minneapolis, Minnesota, 55404
Monroe Carell Jr. Children's Hospital
Nashville, Tennessee, 37232
Children's Hospital and Medical Center Omaha
Omaha, Nebraska, 68114
About this study
The objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals.
Read the detailed description
The Bright STAR Collaborative, or Testing STewardship to reduce Antibiotic Resistance Collaborative, is a prospective multicenter quality improvement (QI) program with the goal of implementing diagnostic stewardship interventions to reduce bacterial culture use as a strategy to reduce antibiotic overuse. Investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients can decrease antibiotic use in pediatric intensive care units. Investigators will perform a quasi-experimental study to compare outcome data in pre- and post- periods.
Greater than or equal to 10 institutions will participate in this collaborative. Participating institutions will develop and implement an evidenced-based clinical decision-making tool as part of their quality improvement (QI) program in their pediatric intensive care unit (PICU).
Specific Aim 1: Evaluate whether locally devised quality improvement programs focused on diagnostic stewardship of respiratory cultures lead to a reduction in respiratory cultures and antibiotic use.
Specific Aim 2: To determine whether these quality improvement initiatives are associated with unintended consequence of patient harm such as mortality, length of stay, readmissions, ventilator associated infections, sepsis and septic shock.
Variables: total respiratory culture rates, culture results, ICU length of stay, mortality rates, hospital and ICU readmission, cause of death, ventilator-associated infection/ventilator-associated condition rate, sepsis, septic shock.
Analysis: The analytic approach equates to estimating and comparing the respiratory culture incidence during the "baseline/pre-implementation" and "post-implementation" periods, using a generalized linear mixed model (GLMM) assuming a Poisson distribution for the monthly number of respiratory cultures with the monthly number of ventilator days as an offset. Similar analyses will be performed for secondary outcomes.
- Conditions
- Ventilator Associated Pneumonia, Tracheobronchitis
- Keywords
- Diagnostic Stewardship, Pediatric, Respiratory Culture Test
- Medical subject headings
- Pneumonia, Ventilator-Associated
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Culture Rate
Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month
Measured: up to 42 months
Secondary outcomes (9)
Broad spectrum antibiotic use for ICU days >2 days
Over all use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter
Measured: up to 42 months
New initiations - Broad spectrum antibiotic use for ICU days >2 days
Antibiotic days per 1,000 patient-days per month (antibiotic days starting on day 3 of ICU admission)
Measured: up to 42 months
Mortality
Death per hospital total ICU admissions comparing pre and post-intervention periods
Measured: up to 42 months
Length of ICU stay
Days in ICU; median number of days comparing pre and post-intervention periods
Measured: up to 42 months
ICU readmission
Readmission to the ICU within 7 days of discharge. The coordinating center will measure the change in rate of readmission per total ICU admissions comparing pre and post-intervention periods
Measured: up to 42 months
Hospital readmission
Readmission to hospital within 7 days of discharge. The coordinating center will measure the change in rate of hospital readmission comparing pre and post-intervention periods
Measured: up to 42 months
ventilator associated infections
Defined by the following: Rate of ventilator associated infections episodes per 100 ventilator-days per month
Measured: up to 42 months
Sepsis
defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions
Measured: up to 42 months
Septic shock
Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions
Measured: up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 May 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Aaron Milstone, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987840
- Sponsor's protocol ID
- IRB00263269
- Other IDs
- K24AI141580, R01HS028634
- Acronym
- BrighT STAR
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children
- ClinicalTrials.gov ID
- NCT04987840
- Acronym / sponsor ID
- BrighT STAR / IRB00263269
- Conditions
- Ventilator Associated Pneumonia, Tracheobronchitis
- Keywords
- Diagnostic Stewardship, Pediatric, Respiratory Culture Test
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals.
Detailed description
The Bright STAR Collaborative, or Testing STewardship to reduce Antibiotic Resistance Collaborative, is a prospective multicenter quality improvement (QI) program with the goal of implementing diagnostic stewardship interventions to reduce bacterial culture use as a strategy to reduce antibiotic overuse. Investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients can decrease antibiotic use in pediatric intensive care units. Investigators will perform a quasi-experimental study to compare outcome data in pre- and post- periods.
Greater than or equal to 10 institutions will participate in this collaborative. Participating institutions will develop and implement an evidenced-based clinical decision-making tool as part of their quality improvement (QI) program in their pediatric intensive care unit (PICU).
Specific Aim 1: Evaluate whether locally devised quality improvement programs focused on diagnostic stewardship of respiratory cultures lead to a reduction in respiratory cultures and antibiotic use.
Specific Aim 2: To determine whether these quality improvement initiatives are associated with unintended consequence of patient harm such as mortality, length of stay, readmissions, ventilator associated infections, sepsis and septic shock.
Variables: total respiratory culture rates, culture results, ICU length of stay, mortality rates, hospital and ICU readmission, cause of death, ventilator-associated infection/ventilator-associated condition rate, sepsis, septic shock.
Analysis: The analytic approach equates to estimating and comparing the respiratory culture incidence during the "baseline/pre-implementation" and "post-implementation" periods, using a generalized linear mixed model (GLMM) assuming a Poisson distribution for the monthly number of respiratory cultures with the monthly number of ventilator days as an offset. Similar analyses will be performed for secondary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICU patient populations from units that develop and implement a quality improvement program to reduce respiratory culture use
Key inclusion criteria (1 listed)
- Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs
Key exclusion criteria (1 listed)
- Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Culture Rate
Time frame: up to 42 months
Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month
9 secondary outcomes
Broad spectrum antibiotic use for ICU days >2 days
Time frame: up to 42 months
New initiations - Broad spectrum antibiotic use for ICU days >2 days
Time frame: up to 42 months
Mortality
Time frame: up to 42 months
Length of ICU stay
Time frame: up to 42 months
ICU readmission
Time frame: up to 42 months
Hospital readmission
Time frame: up to 42 months
ventilator associated infections
Time frame: up to 42 months
Sepsis
Time frame: up to 42 months
Septic shock
Time frame: up to 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Milstone, MD, MHS principal investigator
Johns Hopkins University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia and Tracheobronchitis, run by Johns Hopkins University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Culture Rate (time frame: up to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.