Clinical trial NCT01379547: Procalcitonin to Shorten Antibiotics Duration in ICU Patients
Official title: Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sepsis
Keywords: Procalcitonin
sepsis
ICU
antibiotic
antibiotic duration
Antibiotic treatment duration
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Ruijin Hospital
name: Shanghai Jiao Tong University School of Medicine
name: Chongqing Medical University
name: Tianjin Medical University General Hospital
name: Chinese PLA General Hospital
name: Xinjiang Medical University
name: Princess Margaret Hospital, Hong Kong
First posted: 2011-06-23
Enrollment: 1700
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Average antibiotics duration
timeFrame: 28 days
measure: 28-day mortality rate
timeFrame: 28 days
Secondary outcomes:
measure: Proportion of antibiotics use in both arms
timeFrame: 28 days
measure: Length of ICU stay
timeFrame: 90 days
measure: Recurrence of fever within 72 hours of antibiotics discontinuation
timeFrame: 28 days
measure: APACHE-II score or SOFA score
timeFrame: 28 days
measure: Reinfection between 72-hours and 28 days post antibiotics discontinuation
timeFrame: 28 days
measure: 90-day all-cause mortality
timeFrame: 90 days
measure: 90-day infection related readmission rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Urumqi
country: China
facility: Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Beijing
country: China
facility: Department of Critical Care Medicine, The 301 People Liberation Army General Hospital
city: Beijing
country: China
facility: Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University
city: Shanghai
country: China
facility: Emergency Department, Ruijin Hospital, Jiaotong University, School of Medicine
city: Shanghai
country: China
facility: Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine
city: Tianjin
country: China
facility: Department of Critical Care Medicine, The General Hospital of Tianjin Medical University
city: Lai Chi Kok
country: Hong Kong
facility: Department of Pathology, Princess Margaret Hospita
city: Taipei
country: Taiwan
facility: Department of Emergency, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chien-Chang Lee, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: