A Phase 3 interventional study of Procalcitonin-guided treatment and Conventional treatment in Sepsis, sponsored by Hunan Children's Hospital. Status unknown at 1 site in China. Open to participants aged 1 Month to 15 Years. Per ClinicalTrials.gov, last updated 2012-07-30.
Sponsored by Hunan Children's Hospital · Phase 3, Interventional, and Treatment
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.
1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's planned enrollment of 600 is above the median of 105 across 893 interventional studies indexed under Sepsis.
Browse Sepsis studies →Hunan Children's Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with laboratory- or image-confirmed severe infection at admission or during stay in pediatric ICU will be eligible for inclusion.
* Definition of laboratory- or image-confirmed severe infection:
Two or more of four signs of inflammation:
Exclusion Criteria:
Specific infections for which long-term antibiotic treatment is strongly recommended:
The duration of antibiotics will be determined by the procalcitonin levels.
Behavioral: Procalcitonin-guided treatment
The duration of antibiotics will be determined by the treating physician.
Behavioral: Conventional treatment
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.
Average 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
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Hunan Children's Hospital