Sepsis Clinical Trial
— ProShortOfficial title:
Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial
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
Status | Recruiting |
Enrollment | 1700 |
Est. completion date | June 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
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 Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University | Urumqi | Xinjiang |
Hong Kong | Department of Pathology, Princess Margaret Hospita | Lai Chi Kok | |
Taiwan | Department of Emergency, National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | Beijing Chao Yang Hospital, Chinese PLA General Hospital, Chongqing Medical University, Princess Margaret Hospital, Hong Kong, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Tianjin Medical University General Hospital, Xinjiang Medical University |
China, Hong Kong, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average antibiotics duration | 28 days | No | |
Primary | 28-day mortality rate | Safety endpoints | 28 days | Yes |
Secondary | Proportion of antibiotics use in both arms | 28 days | No | |
Secondary | Length of ICU stay | 90 days | Yes | |
Secondary | Recurrence of fever within 72 hours of antibiotics discontinuation | 28 days | Yes | |
Secondary | APACHE-II score or SOFA score | 28 days | Yes | |
Secondary | Reinfection between 72-hours and 28 days post antibiotics discontinuation | 28 days | Yes | |
Secondary | 90-day all-cause mortality | 90 days | Yes | |
Secondary | 90-day infection related readmission rate | 90 days | Yes |
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