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Enrolling by Invitation

NCT Number: NCT04987840

A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children

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.

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Children's Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

Exclusion criteria

  • Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

Treatment and study plan

Primary outcomes

  1. Respiratory Culture Rate

    Time frame: up to 42 months

    Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month

Secondary outcomes

  1. Broad spectrum antibiotic use for ICU days >2 days

    Time frame: up to 42 months

    Over all use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter

  2. New initiations - Broad spectrum antibiotic use for ICU days >2 days

    Time frame: up to 42 months

    Antibiotic days per 1,000 patient-days per month (antibiotic days starting on day 3 of ICU admission)

  3. Mortality

    Time frame: up to 42 months

    Death per hospital total ICU admissions comparing pre and post-intervention periods

  4. Length of ICU stay

    Time frame: up to 42 months

    Days in ICU; median number of days comparing pre and post-intervention periods

  5. ICU readmission

    Time frame: up to 42 months

    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

  6. Hospital readmission

    Time frame: up to 42 months

    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

  7. ventilator associated infections

    Time frame: up to 42 months

    Defined by the following: Rate of ventilator associated infections episodes per 100 ventilator-days per month

  8. Sepsis

    Time frame: up to 42 months

    defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions

  9. Septic shock

    Time frame: up to 42 months

    Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Acronym: BrighT STAR

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 3, 2021
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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