The purpose of this study is to give conclusive evidence on whether serial PCT (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit).
In this study, the investigators aimed to design a multi-center trial addressing aforementioned flaws. The investigators will set stricter inclusion criteria, collect complete data on relapse or secondary infection, and include sufficient number of patients to show non-inferiority to conventional therapy by a delta margin of 10% \[11\]. The investigators aimed to give conclusive evidence on whether serial PCT measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
The antibiotics duration will be determined by treating physician.
Hunan Children's Hospital
Changsha, Hunan, China
RECRUITINGAverage antibiotics duration
Efficacy endpoint
Time frame: 28 days
28-day mortality rate
Safety endpoint
Time frame: 28 days
Proportion of antibiotics use in both arms
Efficacy endpoint
Time frame: 28 days
Length of ICU stay
Efficacy endpoint
Time frame: 90 days
Recurrence of fever within 72 hours of antibiotics discontinuation
Safety endpoint
Time frame: 28 days
SOFA score (Sequential Organ Failure Assessment score)
Safety endpoint
Time frame: 28 days
Reinfection rate between 72-hours and 28 days post antibiotics discontinuation
Safety endpoint
Time frame: 28 days
90-day all-cause mortality
Safety endpoint
Time frame: 90 days
90-day readmission rate
Safety endpoint
Time frame: 90 days
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