Procalcitonin to Shorten Antibiotics Duration in ICU Patients (ProShort)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by National Taiwan University Hospital
Sponsor:
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
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01379547
First received: June 21, 2011
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Sepsis
Behavioral: Procalcitonin guided antibiotics treatment algorithm
Behavioral: Conventional treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Average antibiotics duration [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 28-day mortality rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety endpoints


Secondary Outcome Measures:
  • Proportion of antibiotics use in both arms [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Recurrence of fever within 72 hours of antibiotics discontinuation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • APACHE-II score or SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Reinfection between 72-hours and 28 days post antibiotics discontinuation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • 90-day all-cause mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • 90-day infection related readmission rate [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1700
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Treatment
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice
Behavioral: Conventional treatment
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.
Experimental: procalcitonin-guided antibiotics treatment
Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm.
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.

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379547

Contacts
Contact: Chien-Chang Lee, MD, MSc +886-972-651951 cclee100@gmail.com

Locations
China, Xinjiang
Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University Recruiting
Urumqi, Xinjiang, China
Principal Investigator: Shiangtai Yu, MD         
China
Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Chunsheng Li, MD         
Principal Investigator: Chunsheng Li, MD         
Department of Critical Care Medicine, The 301 People Liberation Army General Hospital Not yet recruiting
Beijing, China
Principal Investigator: Chin Song, MD         
Emergency Department, Ruijin Hospital, Jiaotong University, School of Medicine Recruiting
Shanghai, China
Contact: Yiming Lu, MD         
Principal Investigator: Yiming Lu, MD         
Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine Recruiting
Shanghai, China
Principal Investigator: Shuming Pan, MD         
Department of Critical Care Medicine, The General Hospital of Tianjin Medical University Recruiting
Tianjin, China
Principal Investigator: Min Peng, MD         
Hong Kong
Department of Pathology, Princess Margaret Hospita Not yet recruiting
Lai Chi Kok, Hong Kong
Principal Investigator: Bosco Lam, MD         
Taiwan
Department of Emergency, National Taiwan University Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Chien-Chang Lee, MD         
Sub-Investigator: Ang Yuan, MD, PhD         
Sub-Investigator: Hsien-Ho Lin, MD ScD         
Sub-Investigator: Shan-Chewn Chang, MD PhD         
Sponsors and Collaborators
National Taiwan University Hospital
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
Investigators
Principal Investigator: Chien-Chang Lee, MD, MSc National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01379547     History of Changes
Other Study ID Numbers: 201101079RB
Study First Received: June 21, 2011
Last Updated: November 26, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Procalcitonin
sepsis
ICU
antibiotic
antibiotic duration
Antibiotic treatment duration

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 16, 2014