- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379547
Procalcitonin to Shorten Antibiotics Duration in ICU Patients (ProShort)
Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Chien-Chang Lee, MD, MSc
- Phone Number: +886-972-651951
- Email: cclee100@gmail.com
Study Locations
-
-
-
Beijing, China
- Not yet recruiting
- Department of Critical Care Medicine, The 301 People Liberation Army General Hospital
-
Principal Investigator:
- Chin Song, MD
-
Beijing, China
- Recruiting
- Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University
-
Contact:
- Chunsheng Li, MD
-
Principal Investigator:
- Chunsheng Li, MD
-
Shanghai, China
- Recruiting
- Emergency Department, Ruijin Hospital, Jiaotong University, School of Medicine
-
Contact:
- Yiming Lu, MD
-
Principal Investigator:
- Yiming Lu, MD
-
Shanghai, China
- Recruiting
- Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine
-
Principal Investigator:
- Shuming Pan, MD
-
Tianjin, China
- Recruiting
- Department of Critical Care Medicine, The General Hospital of Tianjin Medical University
-
Principal Investigator:
- Min Peng, MD
-
-
Xinjiang
-
Urumqi, Xinjiang, China
- Recruiting
- Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University
-
Principal Investigator:
- Shiangtai Yu, MD
-
-
-
-
-
Lai Chi Kok, Hong Kong
- Not yet recruiting
- Department of Pathology, Princess Margaret Hospita
-
Principal Investigator:
- Bosco Lam, MD
-
-
-
-
-
Taipei, Taiwan
- Recruiting
- Department of Emergency, National Taiwan University Hospital
-
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
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional Treatment
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 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average antibiotics duration
Time Frame: 28 days
|
28 days
|
|
28-day mortality rate
Time Frame: 28 days
|
Safety endpoints
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
90-day all-cause mortality
Time Frame: 90 days
|
90 days
|
Proportion of antibiotics use in both arms
Time Frame: 28 days
|
28 days
|
Length of ICU stay
Time Frame: 90 days
|
90 days
|
Recurrence of fever within 72 hours of antibiotics discontinuation
Time Frame: 28 days
|
28 days
|
APACHE-II score or SOFA score
Time Frame: 28 days
|
28 days
|
Reinfection between 72-hours and 28 days post antibiotics discontinuation
Time Frame: 28 days
|
28 days
|
90-day infection related readmission rate
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chien-Chang Lee, MD, MSc, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201101079RB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sepsis
-
University of Kansas Medical CenterUniversity of KansasRecruitingSepsis | Septic Shock | Sepsis Syndrome | Sepsis, Severe | Sepsis Bacterial | Sepsis BacteremiaUnited States
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
-
Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
-
Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsCompletedSepsis | Septic Shock | Severe Sepsis | Sepsis SyndromeUnited Kingdom
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityRecruitingSevere Sepsis | Severe Sepsis Without Septic ShockUnited States
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital and other collaboratorsCompletedSepsis | Septic Shock | Severe Sepsis | Infection | Sepsis SyndromeUnited States
-
Inverness Medical InnovationsCompletedSepsis | Systemic Inflammatory Response Syndrome | Severe Sepsis | Sepsis SyndromeUnited States
Clinical Trials on Conventional treatment
-
University of AarhusGCP-unit at Aarhus University Hospital, Aarhus, Denmark; Danish Classical Homeopathy... and other collaboratorsCompleted
-
Aveiro UniversityFundação para a Ciência e a TecnologiaCompletedLower Respiratory Tract InfectionsPortugal
-
Riphah International UniversityCompletedOverweight | Low Back Pain, MechanicalPakistan
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityCompleted
-
Aveiro UniversityRecruiting
-
Daping Hospital and the Research Institute of Surgery...RecruitingAcute Respiratory Distress Syndrome (ARDS) | Red Blood Cells(RBC)China
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingSudden Sensorineural Hearing LossChina
-
Hangzhou Medical CollegeRecruitingAdolescent ScoliosisChina
-
Riphah International UniversityRecruitingAutism Spectrum DisorderPakistan
-
Karolinska InstitutetStockholm South General HospitalTerminated