Procalcitonin to Shorten Antibiotics Duration in ICU Patients (ProShort)
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ClinicalTrials.gov Identifier: NCT01379547 |
Recruitment Status
: Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted
: June 23, 2011
Last Update Posted
: November 27, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sepsis | Behavioral: Procalcitonin guided antibiotics treatment algorithm Behavioral: Conventional treatment | Phase 3 |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1700 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial |
Study Start Date : | June 2011 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | June 2013 |
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
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Behavioral: Conventional treatment
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.
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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.
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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.
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- Average antibiotics duration [ Time Frame: 28 days ]
- 28-day mortality rate [ Time Frame: 28 days ]Safety endpoints
- Proportion of antibiotics use in both arms [ Time Frame: 28 days ]
- Length of ICU stay [ Time Frame: 90 days ]
- Recurrence of fever within 72 hours of antibiotics discontinuation [ Time Frame: 28 days ]
- APACHE-II score or SOFA score [ Time Frame: 28 days ]
- Reinfection between 72-hours and 28 days post antibiotics discontinuation [ Time Frame: 28 days ]
- 90-day all-cause mortality [ Time Frame: 90 days ]
- 90-day infection related readmission rate [ Time Frame: 90 days ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379547
Contact: Chien-Chang Lee, MD, MSc | +886-972-651951 | cclee100@gmail.com |
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 | |
Department of Critical Care Medicine, The 301 People Liberation Army General Hospital | Not yet recruiting |
Beijing, China | |
Principal Investigator: Chin Song, MD | |
Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University | Recruiting |
Beijing, China | |
Contact: Chunsheng Li, MD | |
Principal Investigator: Chunsheng Li, 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 |
Principal Investigator: | Chien-Chang Lee, MD, MSc | National Taiwan University Hospital |
Responsible Party: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT01379547 History of Changes |
Other Study ID Numbers: |
201101079RB |
First Posted: | June 23, 2011 Key Record Dates |
Last Update Posted: | November 27, 2012 |
Last Verified: | November 2012 |
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 |
Antibiotics, Antitubercular Calcitonin Anti-Infective Agents Antitubercular Agents Bone Density Conservation Agents Physiological Effects of Drugs |