Procalcitonin to Shorten Antibiotics Duration in ICU Patients

Phase 3

• Conditions: Sepsis
• Interventions: Behavioral: Conventional treatment; Behavioral: Procalcitonin guided antibiotics treatment algorithm

• Registration Number: NCT01379547
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-23
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-27
• Primary Completion: 2012-12
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1700

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Treatment	Conventional treatment	Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice
procalcitonin-guided antibiotics treatment	Procalcitonin guided antibiotics treatment algorithm	Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm.

Primary Outcome Measures

Name	Time	Method
Average antibiotics duration	28 days
28-day mortality rate	28 days	Safety endpoints

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Department of Critical Care Medicine, The General Hospital of Tianjin Medical University; 🇨🇳 Tianjin, China

Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China

Department of Critical Care Medicine, The 301 People Liberation Army General Hospital; 🇨🇳 Beijing, China

Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University; 🇨🇳 Beijing, China

Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine; 🇨🇳 Shanghai, China

Emergency Department, Ruijin Hospital, Jiaotong University, School of Medicine; 🇨🇳 Shanghai, China

Department of Emergency, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Department of Pathology, Princess Margaret Hospita; 🇭🇰 Lai Chi Kok, Hong Kong