NCT01652404

PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Hunan Children's Hospital · Other Government
• Sex: All
• Age: 1 Month – 15 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
BEHAVIORAL	Procalcitonin-guided treatment	The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
BEHAVIORAL	Conventional treatment	The antibiotics duration will be determined by treating physician.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-07-30
• Last updated: 2012-07-30

Locations

1 site across 1 country: China