SepsisPhase 3ProShortNCT01379547
Procalcitonin to Shorten Antibiotics Duration in ICU Patients
A Phase 3 study testing Procalcitonin guided antibiotics treatment algorithm and Conventional treatment in people with Sepsis, run by National Taiwan University Hospital at 8 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Procalcitonin guided antibiotics treatment algorithm and Conventional treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
China6 sites, 6 recruiting
- Not yet recruiting
Department of Critical Care Medicine, The 301 People Liberation Army General Hospital
Beijing
Chin Song, MD
- Recruiting
Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Chunsheng Li, MD
Chunsheng Li, MD
- Recruiting
Emergency Department, Ruijin Hospital, Jiaotong University, School of Medicine
Shanghai
Yiming Lu, MD
Yiming Lu, MD
- Recruiting
Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine
Shanghai
Shuming Pan, MD
- Recruiting
Department of Critical Care Medicine, The General Hospital of Tianjin Medical University
Tianjin
Min Peng, MD
- Recruiting
Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Shiangtai Yu, MD
Hong Kong1 site, 1 recruiting
- Not yet recruiting
Department of Pathology, Princess Margaret Hospita
Lai Chi Kok
Bosco Lam, MD
Taiwan1 site, 1 recruiting
- Recruiting
Department of Emergency, National Taiwan University Hospital
Taipei
Chien-Chang Lee, MD
Ang Yuan, MD, PhD
About this study
Official title: Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial
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
Read the 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
- Conditions
- Sepsis
- Being tested
- Procalcitonin guided antibiotics treatment algorithm, Conventional treatment
- Keywords
- Procalcitonin, sepsis, ICU, antibiotic, antibiotic duration, Antibiotic treatment duration
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin guided antibiotics treatment algorithmBehavioural
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.
Conventional treatmentBehavioural
Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice Receives: Behavioral: Conventional treatment |
| procalcitonin-guided antibiotics treatment | Experimental | Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm. Receives: Behavioral: Procalcitonin guided antibiotics treatment algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average antibiotics duration
Measured: 28 days
28-day mortality rate
Safety endpoints
Measured: 28 days
Secondary outcomes (7)
Proportion of antibiotics use in both arms
Measured: 28 days
Length of ICU stay
Measured: 90 days
Recurrence of fever within 72 hours of antibiotics discontinuation
Measured: 28 days
APACHE-II score or SOFA score
Measured: 28 days
Reinfection between 72-hours and 28 days post antibiotics discontinuation
Measured: 28 days
90-day all-cause mortality
Measured: 90 days
90-day infection related readmission rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Chien-Chang Lee, MD, MSc, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379547
- Sponsor's protocol ID
- 201101079RB
- Acronym
- ProShort
- Status last verified
- Nov 2012
- First submitted
- 21 Jun 2011
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial
- ClinicalTrials.gov ID
- NCT01379547
- Acronym / sponsor ID
- ProShort / 201101079RB
- Conditions
- Sepsis
- Keywords
- Procalcitonin, sepsis, ICU, antibiotic, antibiotic duration, Antibiotic treatment duration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- 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
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | Active comparator | Behavioral: Conventional treatmentPatients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice |
| procalcitonin-guided antibiotics treatment | Experimental | Behavioral: Procalcitonin guided antibiotics treatment algorithmPatients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All patients with laboratory- or image-confirmed severe infection at admission or during stay in ICU will be eligible for inclusion.
- Two or more of four Signs of Inflammation
- Initial Procalcitonin > 0.5 ng/mL
- Presence of either laboratory or image evidence of infection
- Sign of inflammation in urine, CSF, ascites, pleural effusion or local abscess
Key exclusion criteria (6 listed)
- Age less than 20 years
- Known pregnancy
- Presence of DNR order
- Expected ICU stay less than 3 days
- Neutropenia (ANC count < 500/mm3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procalcitonin guided antibiotics treatment algorithmPatients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin measurement on day 5, 7 and 9. | Behavioural | procalcitonin-guided antibiotics treatment |
| Conventional treatmentPatients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice. | Behavioural | Conventional Treatment |
Primary outcome
Average antibiotics duration
Time frame: 28 days
28-day mortality rate
Time frame: 28 days
Safety endpoints
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Chang Lee, MD, MSc principal investigator
National Taiwan University Hospital
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Procalcitonin guided antibiotics treatment algorithm and Conventional treatment in people with Sepsis, run by National Taiwan University Hospital at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China, Hong Kong, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Chang Lee, MD, MSc (+886-972-651951, cclee100@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average antibiotics duration (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.