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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procalcitonin-guided treatment | Experimental | The duration of antibiotics will be determined by the procalcitonin levels. |
|
| Conventional treatment | Active Comparator | The duration of antibiotics will be determined by the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin-guided treatment | Behavioral | The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average antibiotics duration | Efficacy endpoint | 28 days |
| 28-day mortality rate | Safety endpoint | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of antibiotics use in both arms | Efficacy endpoint | 28 days |
| Length of ICU stay | Efficacy endpoint | 90 days |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chien-Chang Lee, MD, MSc | Contact | 886972651951 | cclee100@gmail.com | |
| Yi-Min Zhu, BSc | Contact | 073185356850 | csvzhuyimin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chien-Chang Lee, MD, MSc | National Taiwan University Hospital | Principal Investigator |
| Yi-Min Zhu, BSc | Hunan Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Children's Hospital | Recruiting | Changsha | Hunan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12535494 | Background | Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short versus standard duration oral antibiotic therapy for acute urinary tract infection in children. Cochrane Database Syst Rev. 2003;(1):CD003966. doi: 10.1002/14651858.CD003966. | |
| 21034941 | Background | Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Conventional treatment | Behavioral | The antibiotics duration will be determined by treating physician. |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |