Sepsis
Conditions
Keywords
Procalcitonin, sepsis, ICU, antibiotic, antibiotic duration, Antibiotic treatment duration
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
Interventions
BEHAVIORALProcalcitonin 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.
BEHAVIORALConventional treatment
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.
Sponsors
Beijing Chao Yang Hospital
Ruijin Hospital
Shanghai Jiao Tong University School of Medicine
Chongqing Medical University
Tianjin Medical University General Hospital
Chinese PLA General Hospital
Xinjiang Medical University
Princess Margaret Hospital, Hong Kong
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average antibiotics duration | 28 days | — |
| 28-day mortality rate | 28 days | Safety endpoints |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of fever within 72 hours of antibiotics discontinuation | 28 days |
| APACHE-II score or SOFA score | 28 days |
| Proportion of antibiotics use in both arms | 28 days |
| 90-day all-cause mortality | 90 days |
| 90-day infection related readmission rate | 90 days |
| Reinfection between 72-hours and 28 days post antibiotics discontinuation | 28 days |
| Length of ICU stay | 90 days |
Countries
China, Hong Kong, Taiwan
Contacts
Primary ContactChien-Chang Lee, MD, MSc
Outcome results
None listed