An observational study in Sepsis and Bacteremia, sponsored by Johns Hopkins University. Completed at 5 sites in United States. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by Johns Hopkins University · Observational
Among 79 studies in Bacteremia with a site in United States — 6 open to participants now, 8 under way, none of them phase 3. Bacteremia · United States.
Among the 79 studies in Bacteremia with a site in United States, this one is the 30th largest by enrollment of the 32 observational ones, is one of 2 that started in 2018, is one of 32 observational ones, and was the 62nd registered.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's enrollment of 15 is below the median of 300 across 125 observational studies indexed under Bacteremia.
Browse Bacteremia studies →6 of the 79 studies in Bacteremia with a site in United States are open now, in 7 countries. Each count lists the studies.
Of the 40 Bacteremia studies recruiting now, 32 (80%) set no upper age limit and 4 (10%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →79 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2018.
Median enrollment 85 across the 45 interventional studies, 470 across the 32 observational. Of the 64 that completed or were terminated, 24 (38%) have results posted.
30 of 79 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 2 studies filed under Bacteremia — fewer than ten, so there is no comparison to draw.
4 of the studies in Bacteremia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07859852Deepull Diagnostics S.L.Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test | 2027-04 |
| NCT01879761University of ChicagoImmune Resolution After Staphylococcus Aureus Bacteremia | 2027-06 |
| NCT07148960West Virginia UniversityDoes Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes? | 2027-07 |
| NCT05721781Wake Forest University Health SciencesReducing Risk for Infective Endocarditis | 2027-09 |
Among the 79 studies in Bacteremia with a site in United States, from their registry updates:
This study will test the hypothesis that reliable implementation of an evidence-based clinical practice guideline for evaluation of patients with signs and symptoms of sepsis will decrease antibiotic use in pediatric intensive care units (PICUs).
The Bright STAR Collaborative (BSC), or Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children Collaborative, is a multicenter quality improvement program to reduce blood culture use within pediatric intensive care units. Investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients with signs and symptoms of sepsis 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).
Aim 1: To determine if reliable implementation of clinical practice guidelines for evaluation of patients with signs and symptoms of sepsis can decrease blood culture use in pediatric intensive care units.
Aim 2: To determine if reliable implementation of clinical practice guidelines for evaluation of patients with signs and symptoms of sepsis can decrease central line-associated bloodstream infections in pediatric intensive care units.
Aim 3. To determine if reliable implementation of clinical practice guidelines for evaluation of patients with signs and symptoms of sepsis can reduce antibiotic use and Clostridium difficile infection.
Aim 4. To determine whether a clinical practice guideline for evaluation of patients with signs and symptoms of sepsis in the PICU has an unintended consequence of patient harm.
Aim 5. To evaluate the implementation of a multi-institutional quality improvement initiative and identify strategies for successful scale-up and adoption of similar practice guidelines in other clinical settings.
Variables: blood cultures and central line-associated blood stream infections (CLABSIs), antibiotic use, , episodes of Clostridium difficile infection mortality, length of stay, ICU readmission, hospital readmission, episodes of sepsis, and episodes of septic shock.
Analyses: The analytic approach equates to estimating and comparing the blood 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 blood cultures with the monthly number of patient days as an offset. Similar analyses will be conducted to evaluate the incidence of blood cultures drawn from central lines and CLABSIs. Due to the expected low incidence of CLABSIs, investigators will define time in quarters, not months, for that outcome. Similar analyses will be performed for secondary outcomes.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's enrollment of 15 is below the median of 300 across 125 observational studies indexed under Bacteremia.
Browse Bacteremia studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Compared within Bacteremia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
ICU patient populations from units that develop and implement a quality improvement program to reduce blood culture use
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Locally developed and reliably implemented ICU Quality Improvement program to reduce blood culture use.
Other: Multicenter Quality Improvement program
Participating institutions will not participate in an intervention study. Sites will design and implement local QI programs to improve care within their unit. Local healthcare teams, who are interested in directly and immediately improving patient outcomes, will devise customized tools. The Bright STAR Team will assess the impact of these local QI initiatives on patient health outcomes, using data that are collected as part of the QI programs or through routine clinical care.
Blood culture rate
The primary outcome of interest is blood culture rate in participating PICUs. A blood culture will be defined as any blood culture processed by the clinical microbiology laboratory.
Time frame: Change in blood cultures per 100 patient days per month at 42 months
Central line-associated bloodstream infections (CLABSI).
The secondary outcome of interest is CLABSIs in participating PICUs. The outcome measurement will include a denominator of catheter days in the participating units.We will measure the change in CLABSI rate per month.
Time frame: 42 months
Broad spectrum antibiotic use
Use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter
Time frame: 42 months
Clostridium difficile infection
Incidence of infections per 1000 patient days per quarter
Time frame: 42 months
Mortality
Death per hospital total ICU admissions comparing pre and post-intervention periods
Time frame: 42 months
Length of ICU stay
Days in ICU; median number of days comparing pre and post-intervention periods
Time frame: 42 months
ICU readmission
Readmission to the ICU within 7 days of discharge. We will measure the change in rate of readmission per total ICU admissions comparing pre and post-intervention periods
Time frame: 42 months
Hospital readmission
Readmission to hospital within 7 days of discharge where we measured change in rate of hospital readmission comparing pre and post-intervention periods at
Time frame: 42 months
Sepsis
Defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions
Time frame: 42 months
Septic shock
Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions
Time frame: 42 months
Plan to share: No — We will not collect any. We will only gather summary-level non Patient Health Information (PHI) from participating sites.
Ran from Apr 2018 to primary completion in Dec 2021, 44 months.
Of 32 non-industry observational studies under Bacteremia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 44 months is above that.
Counting every sponsor, half of 39 studies reached it within 21 months; a quarter within 11 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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