SepsisPRODANCT02202941
Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients
A study testing Procalcitonin guided treatment and Conventional treatment in people with Sepsis, run by Seoul National University Hospital at 4 sites in South Korea.
Trial summary
This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Procalcitonin guided treatment and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Aug 2014to Mar 2015
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with suspicious or confirmed sepsis at admission or during stay in ICU
- Patients with antibiotic duration of less than 48 hours before enrollment
Who cannot join
- Age less than or equal to 18 years
- Known pregnancy
- Specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al.
- severe immunocompromised patients : HIV infected patients (CD4 count < 200 cells/mm3), Neutropenia (ANC count < 500/mm3)
- Presence of do-not-resuscitate order
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Hospital
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul
Severance Hospital
Seoul
About this study
Official title: Effect of Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients in Korea
This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.
- Conditions
- Sepsis
- Being tested
- Procalcitonin guided treatment, Conventional treatment
- 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 treatmentOther
Patients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13.
Conventional treatmentOther
Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonin guided treatment | Experimental | Patients who will be randomized to this arm will receive antibiotics therapy based on procalcitonin-guided algorithm. Receives: Other: Procalcitonin guided treatment |
| Conventional treatment | Active comparator | Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotic treatment
Measured: up to 28 days
Secondary outcomes (4)
Clinical response to treatment for infection
success vs failure vs relapse after treatment
Measured: up to 28 days
In ICU mortality
Measured: up to 28 days
All cause mortality
Measured: up to 28 days
In hospital mortality
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Seoul National 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency, Asan Medical Center, Samsung Medical Center, Severance Hospital
- Responsible party
- Principal investigator, Sang-Min Lee, Seoul National University Hospital
- Investigators
- Sang-Min Lee, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202941
- Sponsor's protocol ID
- PRODA-2014
- Acronym
- PRODA
- Status last verified
- Nov 2018
- First submitted
- 24 Jul 2014
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jeon K, Suh JK, Jang EJ, Cho S, Ryu HG, Na S, Hong SB, Lee HJ, Kim JY, Lee SM. Procalcitonin-Guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients (PRODA): a Multi-Center Randomized Controlled Trial. J Korean Med Sci. 2019 Apr 15;34(14):e110. doi: 10.3346/jkms.2019.34.e110.
PubMed 30977312
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients in Korea
- ClinicalTrials.gov ID
- NCT02202941
- Acronym / sponsor ID
- PRODA / PRODA-2014
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency, Asan Medical Center, Samsung Medical Center, Severance Hospital
- Study start
- Aug 2014 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jul 2014 (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.
This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin guided treatment | Experimental | Other: Procalcitonin guided treatmentPatients who will be randomized to this arm will receive antibiotics therapy based on procalcitonin-guided algorithm. |
| Conventional treatment | Active comparator | Other: Conventional treatmentPatients who will be randomized to this arm will receive antibiotic therapy based on conventional practice. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with suspicious or confirmed sepsis at admission or during stay in ICU
- Patients with antibiotic duration of less than 48 hours before enrollment
Key exclusion criteria (5 listed)
- Age less than or equal to 18 years
- Known pregnancy
- Specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al.
- severe immunocompromised patients : HIV infected patients (CD4 count < 200 cells/mm3), Neutropenia (ANC count < 500/mm3)
- Presence of do-not-resuscitate order
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 treatmentPatients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13. | Other | Procalcitonin guided treatment |
| Conventional treatmentPatients who will be randomized to this arm will receive antibiotic therapy based on conventional practice. | Other | Conventional treatment |
Primary outcome
Duration of antibiotic treatment
Time frame: up to 28 days
4 secondary outcomes
Clinical response to treatment for infection
Time frame: up to 28 days
In ICU mortality
Time frame: up to 28 days
All cause mortality
Time frame: up to 28 days
In hospital mortality
Time frame: up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Derived from this study: PubMed 30977312Jeon K, Suh JK, Jang EJ, Cho S, Ryu HG, Na S, Hong SB, Lee HJ, Kim JY, Lee SM. Procalcitonin-Guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients (PRODA): a Multi-Center Randomized Controlled Trial. J Korean Med Sci. 2019 Apr 15;34(14):e110. doi: 10.3346/jkms.2019.34.e110.
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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.
Sang-Min Lee, M.D. principal investigator
Seoul National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin guided treatment and Conventional treatment in people with Sepsis, run by Seoul National University Hospital at 4 sites in South Korea.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of antibiotic treatment (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202941, which also lists 1 linked publication.
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 2 Nov 2018.