Sepsis
Conditions
Keywords
ICU, sepsis, antibiotic therapy, procalcitonin
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.
Interventions
BEHAVIORALProcalcitonin-guided treatment
The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
BEHAVIORALConventional treatment
The antibiotics duration will be determined by treating physician.
Sponsors
National Taiwan University Hospital
Hunan Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average antibiotics duration | 28 days | Efficacy endpoint |
| 28-day mortality rate | 28 days | Safety endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of fever within 72 hours of antibiotics discontinuation | 28 days | Safety endpoint |
| SOFA score (Sequential Organ Failure Assessment score) | 28 days | Safety endpoint |
| Proportion of antibiotics use in both arms | 28 days | Efficacy endpoint |
| 90-day all-cause mortality | 90 days | Safety endpoint |
| 90-day readmission rate | 90 days | Safety endpoint |
| Reinfection rate between 72-hours and 28 days post antibiotics discontinuation | 28 days | Safety endpoint |
| Length of ICU stay | 90 days | Efficacy endpoint |
Countries
China
Contacts
Primary ContactChien-Chang Lee, MD, MSc
Backup ContactYi-Min Zhu, BSc
Outcome results
None listed