Procalcitonin to Shorten Antibiotics Duration in ICU Patients (ProShort)
This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
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
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
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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
- 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
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:
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
Contacts and Locations
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:
|
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013