Procalcitonin to Shorten Antibiotics Duration in ICU Patients

National Taiwan University Hospital1,700 enrolled

Overview

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

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 1. To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in ICU sepsis patients 2. To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,700

Conditions

Sepsis

Interventions

Procalcitonin guided antibiotics treatment algorithmBEHAVIORAL

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.

Conventional treatmentBEHAVIORAL

Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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: 1. 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 2. Initial Procalcitonin \> 0.5 ng/mL 3. 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

Locations (8)

Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

RECRUITING

Department of Critical Care Medicine, The 301 People Liberation Army General Hospital

Beijing, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Average antibiotics duration

Time frame: 28 days

28-day mortality rate

Safety endpoints

Time frame: 28 days

Secondary Outcomes

Proportion of antibiotics use in both arms

Time frame: 28 days

Length of ICU stay

Time frame: 90 days

Recurrence of fever within 72 hours of antibiotics discontinuation

Time frame: 28 days

APACHE-II score or SOFA score

Time frame: 28 days

Reinfection between 72-hours and 28 days post antibiotics discontinuation

Time frame: 28 days

90-day all-cause mortality

Time frame: 90 days

90-day infection related readmission rate

Time frame: 90 days

Central Contacts

Chien-Chang Lee, MD, MSc

CONTACT

+886-972-651951 cclee100@gmail.com

Data from ClinicalTrials.gov

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