Procalcitonin to Shorten Antibiotics Duration in ICU Patients

Sepsis Clinical Trial

— ProShort  

Official title:

Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01379547
• Other study ID #: 201101079RB
• Status: Recruiting
• Phase: Phase 3
• First received: June 21, 2011
• Last updated: November 26, 2012
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: Chien-Chang Lee, MD, MSc
• Phone: +886-972-651951
• Email: cclee100[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis

Intervention

Behavioral:
• 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.

Locations

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

Sponsors (9)

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

Countries where clinical trial is conducted

China,  Hong Kong,  Taiwan, 

Outcome

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