PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Hunan Children's Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Average antibiotics duration
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Average antibiotics duration
Time Frame: 28 days
Efficacy endpoint
28-day mortality rate
Time Frame: 28 days
Safety endpoint
Secondary Outcomes
- Proportion of antibiotics use in both arms(28 days)
- Length of ICU stay(90 days)
- Recurrence of fever within 72 hours of antibiotics discontinuation(28 days)
- SOFA score (Sequential Organ Failure Assessment score)(28 days)
- Reinfection rate between 72-hours and 28 days post antibiotics discontinuation(28 days)
- 90-day all-cause mortality(90 days)
- 90-day readmission rate(90 days)