N/A
N=271
Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
Sepsis · Procalcitonin · Antimicrobial Stewardship
Bottom Line
View on ClinicalTrials.gov: NCT03440918 ↗Enrolled (actual)
271
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Days of Antibiotic Therapy in the First 14 Days Following Randomization — 7.6; 6.6 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Procalcitonin-Guided Antimicrobial Stewardship (Other); Baseline Antimicrobial Stewardship (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days of Antibiotic Therapy in the First 14 Days Following Randomization |
7.6; 6.6 | — |
| SECONDARY Duration of Broad-spectrum Antibiotic Therapy |
0; 0.086 | — |
| SECONDARY Number of Patients With an Antibiotic Change |
111; 108 | — |
| SECONDARY 30-day Mortality |
4; 3 | — |
| SECONDARY Re-initiation of Antibiotics for a Bacterial Infection |
NA; NA | — |
| SECONDARY Length of Intensive Care Unit Stay |
2; 2 | — |
| SECONDARY Length of Overall Hospital Stay |
7; 6 | — |
| SECONDARY Ventilator Days |
3.9; 4.4 | — |
| SECONDARY Number of Participants With Antibiotic-associated Complications |
2; 3 | — |
| SECONDARY Infection With a Multi-drug Resistant Organism |
1; 2 | — |
| SECONDARY Antibiotic Cost |
NA; NA | — |
| SECONDARY Number of Participants Whose Provider Adhered to the Procalcitonin-guided Algorithm |
123; 121 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03440918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.