Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
ProPICU
Prospective, Randomized Controlled Trial to Evaluate the Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
1 other identifier
interventional
271
1 country
1
Brief Summary
The timely use of antibiotics can reduce morbidity and mortality associated with bacterial infections, particularly in the intensive care unit setting (ICU). Long courses of antibiotics, however, are associated with the emergence of multi-drug resistant organisms and antibiotic-associated adverse events, such as C. difficile infections. Thus, antibiotic de-escalation is an important goal of antimicrobial stewardship programs. Procalcitonin (PCT) has been investigated as a biomarker for critically ill adult patients with bacterial infection, particularly pneumonia and sepsis. The proposed project will evaluate whether a PCT testing and treatment algorithm, implemented through daily antimicrobial stewardship audit and feedback, can promote early and safe antibiotic de-escalation in the pediatric ICU.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable sepsis
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2018
CompletedStudy Start
First participant enrolled
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2019
CompletedResults Posted
Study results publicly available
April 22, 2020
CompletedApril 22, 2020
April 1, 2020
1.2 years
February 8, 2018
March 24, 2020
April 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days of Antibiotic Therapy in the First 14 Days Following Randomization
Days of antibiotic therapy a participant receives following randomization will be measured
14 days
Secondary Outcomes (11)
Duration of Broad-spectrum Antibiotic Therapy
up to14 days
Number of Patients With an Antibiotic Change
up to 14 days
30-day Mortality
up to 30 days
Re-initiation of Antibiotics for a Bacterial Infection
up to 30 days
Length of Intensive Care Unit Stay
up to 14 days
- +6 more secondary outcomes
Study Arms (2)
Baseline Antimicrobial Stewardship
ACTIVE COMPARATORBaseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
Procalcitonin-Guided Antimicrobial Stewardship
EXPERIMENTALIn addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
Interventions
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
Eligibility Criteria
You may qualify if:
- years of age or younger
- Prescribed or administered antibiotics in the hospital less than or equal to 24 hours prior to enrollment
- Have parents or legal guardians who provide informed consent
- Provide assent (if \> 7 years of age)
You may not qualify if:
- Are not prescribed antibiotics in the hospital
- Receive intravenous antibiotics within 7 days prior to identification for study enrollment
- Primary or secondary immune deficiency
- History of malignancy, bone marrow transplant or solid organ transplant
- A diagnosis of cystic fibrosis
- Neonates \< 34 weeks gestation
- Patients receiving treatment for endocarditis, osteomyelitis, meningitis, mediastinitis or other invasive infection, for which long duration of antibiotics is needed
- Do not provide informed consent/assent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Katz SE, Crook J, Gillon J, Stanford JE, Wang L, Colby JM, Banerjee R. Use of a Procalcitonin-guided Antibiotic Treatment Algorithm in the Pediatric Intensive Care Unit. Pediatr Infect Dis J. 2021 Apr 1;40(4):333-337. doi: 10.1097/INF.0000000000002986.
PMID: 33181782DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sophie Katz
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ritu Banerjee, MD, PhD
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Fellow
Study Record Dates
First Submitted
February 8, 2018
First Posted
February 22, 2018
Study Start
February 12, 2018
Primary Completion
May 11, 2019
Study Completion
May 11, 2019
Last Updated
April 22, 2020
Results First Posted
April 22, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share