Procalcitonin to Shorten Antibiotics Duration in ICU Patients
NCT ID: NCT01379547
Last Updated: 2012-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1700 participants
INTERVENTIONAL
2011-06-30
2013-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Treatment
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice
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
Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm.
Procalcitonin guided antibiotics treatment algorithm
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.
Interventions
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Procalcitonin guided antibiotics treatment algorithm
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 treatment
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.
Eligibility Criteria
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Inclusion Criteria
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
* 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
20 Years
ALL
No
Sponsors
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Beijing Chao Yang Hospital
OTHER
Ruijin Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Chongqing Medical University
OTHER
Tianjin Medical University General Hospital
OTHER
Chinese PLA General Hospital
OTHER
Xinjiang Medical University
OTHER
Princess Margaret Hospital, Hong Kong
OTHER_GOV
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chien-Chang Lee, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, 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, Ruijin Hospital, Jiaotong University, School of Medicine
Shanghai, , China
Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine
Shanghai, , China
Department of Critical Care Medicine, The General Hospital of Tianjin Medical University
Tianjin, , China
Department of Pathology, Princess Margaret Hospita
Lai Chi Kok, , Hong Kong
Department of Emergency, National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chunsheng Li, MD
Role: primary
Yiming Lu, MD
Role: primary
Other Identifiers
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201101079RB
Identifier Type: -
Identifier Source: org_study_id