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Procalcitonin to Shorten Antibiotics Duration in ICU Patients (ProShort)

Primary Purpose

Sepsis

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Procalcitonin guided antibiotics treatment algorithm
Conventional treatment
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Procalcitonin, sepsis, ICU, antibiotic, antibiotic duration, Antibiotic treatment duration

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
  • Department of Critical Care Medicine, The 301 People Liberation Army General Hospital
  • Emergency Department, Beijing Chao-Yang Hospital, Capital Medical UniversityRecruiting
  • Emergency Department, Ruijin Hospital, Jiaotong University, School of MedicineRecruiting
  • Emergency Department, Xinhua Hospital, Jiaotong University School of MedicineRecruiting
  • Department of Critical Care Medicine, The General Hospital of Tianjin Medical UniversityRecruiting
  • Department of Pathology, Princess Margaret Hospita
  • Department of Emergency, National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Treatment

procalcitonin-guided antibiotics treatment

Arm Description

Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice

Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm.

Outcomes

Primary Outcome Measures

Average antibiotics duration
28-day mortality rate
Safety endpoints

Secondary Outcome Measures

Proportion of antibiotics use in both arms
Length of ICU stay
Recurrence of fever within 72 hours of antibiotics discontinuation
APACHE-II score or SOFA score
Reinfection between 72-hours and 28 days post antibiotics discontinuation
90-day all-cause mortality
90-day infection related readmission rate

Full Information

First Posted
June 21, 2011
Last Updated
November 26, 2012
Sponsor
National Taiwan University Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT01379547
Brief Title
Procalcitonin to Shorten Antibiotics Duration in ICU Patients
Acronym
ProShort
Official Title
Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in ICU sepsis patients To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Procalcitonin, sepsis, ICU, antibiotic, antibiotic duration, Antibiotic treatment duration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm Description
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice
Arm Title
procalcitonin-guided antibiotics treatment
Arm Type
Experimental
Arm Description
Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm.
Intervention Type
Behavioral
Intervention Name(s)
Procalcitonin guided antibiotics treatment algorithm
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional treatment
Intervention Description
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.
Primary Outcome Measure Information:
Title
Average antibiotics duration
Time Frame
28 days
Title
28-day mortality rate
Description
Safety endpoints
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Proportion of antibiotics use in both arms
Time Frame
28 days
Title
Length of ICU stay
Time Frame
90 days
Title
Recurrence of fever within 72 hours of antibiotics discontinuation
Time Frame
28 days
Title
APACHE-II score or SOFA score
Time Frame
28 days
Title
Reinfection between 72-hours and 28 days post antibiotics discontinuation
Time Frame
28 days
Title
90-day all-cause mortality
Time Frame
90 days
Title
90-day infection related readmission rate
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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: 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 Initial Procalcitonin > 0.5 ng/mL 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Chang Lee, MD, MSc
Phone
+886-972-651951
Email
cclee100@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Chang Lee, MD, MSc
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiangtai Yu, MD
Facility Name
Department of Critical Care Medicine, The 301 People Liberation Army General Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin Song, MD
Facility Name
Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunsheng Li, MD
First Name & Middle Initial & Last Name & Degree
Chunsheng Li, MD
Facility Name
Emergency Department, Ruijin Hospital, Jiaotong University, School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiming Lu, MD
First Name & Middle Initial & Last Name & Degree
Yiming Lu, MD
Facility Name
Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuming Pan, MD
Facility Name
Department of Critical Care Medicine, The General Hospital of Tianjin Medical University
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Peng, MD
Facility Name
Department of Pathology, Princess Margaret Hospita
City
Lai Chi Kok
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bosco Lam, MD
Facility Name
Department of Emergency, National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Chang Lee, MD
First Name & Middle Initial & Last Name & Degree
Ang Yuan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hsien-Ho Lin, MD ScD
First Name & Middle Initial & Last Name & Degree
Shan-Chewn Chang, MD PhD

12. IPD Sharing Statement

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Procalcitonin to Shorten Antibiotics Duration in ICU Patients

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