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

Phase 3

• Conditions: Sepsis
• Interventions: Behavioral: Procalcitonin-guided treatment; Behavioral: Conventional treatment

• Registration Number: NCT01652404
• Lead Sponsor: Hunan Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-08-22
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-27
• Last Update Submitted: 2012-07-27
• Study First Posted: 2012-07-30
• Last Update Posted: 2012-07-30
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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:

  • Temperature >38.3℃ or <36℃
  • Heart rate > 90 beats/min
  • Respiratory rate >20 breaths/min or PaCO2 (Arterial pressure of carbon dioxide) < 32 mmHg
  • WBC (White Blood Cell count) > 12,000 cells/mm3, <4000 cells/mm3, or >5% band-form WBC

• Initial Procalcitonin > 0.5 ng/mL

• Presence of either laboratory or image evidence of infection

• Laboratory evidence: Sign of inflammation in urine, CSF (Cerebrospinal Fluid), ascites, pleural effusion or local abscess

• Image evidence: Compatible findings on Chest X ray, ultrasound, CT (Computed Tomography), MR image (Magnetic Resonance Image)

Exclusion Criteria

• Age greater than 15 years or less than 1 month

• Known pregnancy

• Expected ICU stay less than 3 days

• Neutropenia: ANC (Absolute Neutrophil Count) <500/mm3

• Specific infections for which long-term antibiotic treatment is strongly recommended:

  • Lobar pneumonia or empyema
  • Bacterial meningitis
  • Osteomyelitis
  • Infective endocarditis
  • Local abscess
  • Mediastinitin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procalcitonin-guided treatment	Procalcitonin-guided treatment	The duration of antibiotics will be determined by the procalcitonin levels.
Conventional treatment	Conventional treatment	The duration of antibiotics will be determined by the treating physician.

Primary Outcome Measures

Name	Time	Method
Average antibiotics duration	28 days	Efficacy endpoint
28-day mortality rate	28 days	Safety endpoint

Secondary Outcome Measures

Name	Time	Method
Proportion of antibiotics use in both arms	28 days	Efficacy endpoint
Length of ICU stay	90 days	Efficacy endpoint
Recurrence of fever within 72 hours of antibiotics discontinuation	28 days	Safety endpoint
SOFA score (Sequential Organ Failure Assessment score)	28 days	Safety endpoint
Reinfection rate between 72-hours and 28 days post antibiotics discontinuation	28 days	Safety endpoint
90-day all-cause mortality	90 days	Safety endpoint
90-day readmission rate	90 days	Safety endpoint

Trial Locations

Locations (1)

Hunan Children's Hospital; 🇨🇳 Changsha, Hunan, China