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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Behavioral: Procalcitonin-guided treatment
* Behavioral: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procalcitonin-guided treatment<br>The duration of antibiotics will be determined by the procalcitonin levels. | Behavioral: Procalcitonin-guided treatment<br>* The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.<br>|
| Active Comparator: Conventional treatment<br>The duration of antibiotics will be determined by the treating physician. | Behavioral: Conventional treatment<br>* The antibiotics duration will be determined by treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average antibiotics duration | Efficacy endpoint | 28 days | 
| 28-day mortality rate | Safety endpoint | 28 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU, sepsis, antibiotic therapy, procalcitonin