Procalcitonin to Shorten Antibiotics Duration in ICU Patients

Study Overview
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Brief Summary
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The trial is aimed to show that implementation of a procalcitonin-guided antibiotics algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior outcome as compared to the conventional therapy

Detailed Description
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The duration of antibiotic therapy in patients with sepsis is largely empirical. An extended treatment course for up to two weeks is a common practice for patients with sepsis in the ICU, despite lack of evidence for this duration of therapy. Procalcitonin (PCT) is a new biomarker that has high negative predictive value for systemic bacterial infection. The purpose of this trial is to evaluate whether serial PCT measurements can shorten antibiotic treatment duration in patients with sepsis in the ICU. Specific Aims To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in ICU sepsis patients To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy

Official Title
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Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial

Conditions
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Sepsis

Intervention / Treatment
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* Behavioral: Procalcitonin guided antibiotics treatment algorithm
* 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 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 < 32 mmHg WBC > 12,000 cells/mm3, < 4000 cells/mm3, or > 10% bands Initial Procalcitonin > 0.5 ng/mL Presence of either laboratory or image evidence of infection Laboratory evidence: Sign of inflammation in urine, CSF, ascites, pleural effusion or local abscess Image evidence: Compatible findings on Chest X ray、ultrasound、CT、or MR image Exclusion Criteria: Age less than 20 years Known pregnancy Presence of DNR order Expected ICU stay less than 3 days Neutropenia (ANC count < 500/mm3) Specific infections for which long-term antibiotic treatment is strongly recommended: lung abscess or empyema, bacterial meningitis, osteomyelitis, infective endocarditis, local abscess, mediastinitis

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: Conventional Treatment<br>Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice | Behavioral: Conventional treatment<br>* Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.<br>|
| Experimental: procalcitonin-guided antibiotics treatment<br>Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm. | Behavioral: Procalcitonin guided antibiotics treatment algorithm<br>* Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin measurement on day 5, 7 and 9.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| APACHE-II score or SOFA score |  | 28 days | 
| Reinfection between 72-hours and 28 days post antibiotics discontinuation |  | 28 days | 
| 90-day all-cause mortality |  | 90 days | 
| 90-day infection related readmission rate |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, ICU, antibiotic, antibiotic duration, Antibiotic treatment duration, Procalcitonin