SepsisNCT06945510
PCT Guided Antibiotics Use in Critically Ill Adult Patients in China
A study testing PCT detection in people with Sepsis, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Procalcitonin (PCT) has been widely used in the diagnosis and treatment of bacterial infectious diseases in China. The investigators aim to establish an algorithm based on BRAHMS PCT (VIDAS PCT) for patients with severe infections or sepsis in the EICU to reduce antibiotic exposure and verify its validity in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- PCT detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18
- Suspected or confirmed bacterial patients
- Stay EICU more than 3 days
Who cannot join
- age under 18 years;
- PCT concentration throughout the entire hospitalization less than 0.5 ng/ml ;
- known pregnancy; expected stay in the EICU less than 3 days;
- bone-marrow transplant or chemotherapy-induced neutropenia (<500 neutrophils per mL);
- infections for which long-term antibiotic treatment is strongly recommended (ie, infective endocarditis, osteoarticular infections, anterior mediastinitis after cardiac surgery, hepatic or cerebral abscesses, chronic prostatitis, or infection with Mycobacterium tuberculosis, Pneumocystis jirovecii, or Toxoplasma gondii);
- poor chance of survival, defined as a simplified acute physiology score (SAPS II) of more than 65 points at screening; and do-not-resuscitate orders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, 100029
Shengtao YAN, 0086-010-84205566, yanshengtaozrr@126.com
About this study
Official title: A Multi-center Study to Evaluate the Economic and Clinical Impact of PCT Guided Antibiotics Use in Critically Ill Adult Patients in China.
Procalcitonin (PCT) has been widely used in the diagnosis and treatment of bacterial infectious diseases in China. The investigators aim to establish an algorithm based on BRAHMS PCT (VIDAS PCT) for patients with severe infections or sepsis in the EICU to reduce antibiotic exposure and verify its validity in the reduction of antibiotic exposure, clinical outcomes and costs saving.
Read the detailed description
This is a multi-center prospective study that will establish 9 centers. Based on preliminary on-site assessments, the centers will be grouped into two arms (SOC group and PCT group) according to their capacity for daily monitoring of PCT. Each center will enroll EICU patients with severe infections or sepsis who meet the inclusion and exclusion criteria. A total of 800 patients will be enrolled, with 400 in the PCT group and 400 in the SOC group. In the PCT group, clinicians will prescribe PCT tests every day for enrolled patients, with assigning a dedicated person monitoring the daily PCT results. Once the PCT <0.5 ng/ml or ΔPCT (drop from the peak value) >80%, the clinicians will receive a notification and will strictly adhere to guidelines and PCT values to adjust antibiotic prescriptions. The SOC group will not have any intervention regarding PCT prescriptions and antibiotic adjustments. The clinicians in the SOC group will prescribe PCT at routine frequency (usually once every 2-3 days or even longer) and adjust or discontinue antibiotics according to guidelines and their experiences. The primary and secondary endpoints will be evaluated in both groups. The primary endpoint is the total duration of antibiotic use. The secondary endpoints are the length of EICU stay and the total length of hospital stay.
- Conditions
- Sepsis
- Being tested
- PCT detection
- Keywords
- PCT
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT detectionDevice
Clinicians will prescribe PCT tests every day for enrolled patients, with assigning a dedicated person monitoring the daily PCT results. Once the PCT <0.5 ng/ml or ΔPCT (drop from the peak value) >80%, the clinicians will receive a notification and will strictly adhere to guidelines and PCT values to adjust antibiotic prescriptions.
| Study group | Role | What they receive |
|---|---|---|
| PCT group | Experimental | In the PCT group, clinicians will prescribe PCT tests every day for enrolled patients, with assigning a dedicated person monitoring the daily PCT results. Receives: Device: PCT detection |
| SOC group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total duration of antibiotics use
Measured: From the day the patient was admitted to the EICU until the patient left the EICU, calculate how many days were antibiotics used.
Secondary outcomes (1)
Total length of hospital stay (calculated in days)
Measured: The calculation starts from the first day the patient is admitted to the EICU and extends to the day the patient is discharged (including the possibility of the patient being transferred from the EICU to other departments).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YAN Shengtao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945510
- Sponsor's protocol ID
- PPLS-2173
- Status last verified
- Oct 2024
- First submitted
- 14 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Austin PC. Informing power and sample size calculations when using inverse probability of treatment weighting using the propensity score. Stat Med. 2021 Nov 30;40(27):6150-6163. doi: 10.1002/sim.9176. Epub 2021 Sep 12.
PubMed 34510501Mewes JC, Pulia MS, Mansour MK, Broyles MR, Nguyen HB, Steuten LM. The cost impact of PCT-guided antibiotic stewardship versus usual care for hospitalised patients with suspected sepsis or lower respiratory tract infections in the US: A health economic model analysis. PLoS One. 2019 Apr 23;14(4):e0214222. doi: 10.1371/journal.pone.0214222. eCollection 2019.
PubMed 31013271Chow J, Markossian TW, Albarillo FS, Donahey EE, Bobay KL. Impact of a Procalcitonin-Based Protocol on Antibiotic Exposure and Costs in Critically Ill Patients. Crit Care Explor. 2021 Nov 9;3(11):e0571. doi: 10.1097/CCE.0000000000000571. eCollection 2021 Nov.
PubMed 34778793Hohn A, Balfer N, Heising B, Hertel S, Wiemer JC, Hochreiter M, Schroder S. Adherence to a procalcitonin-guided antibiotic treatment protocol in patients with severe sepsis and septic shock. Ann Intensive Care. 2018 Jun 4;8(1):68. doi: 10.1186/s13613-018-0415-5.
PubMed 29869120
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study to Evaluate the Economic and Clinical Impact of PCT Guided Antibiotics Use in Critically Ill Adult Patients in China.
- ClinicalTrials.gov ID
- NCT06945510
- Acronym / sponsor ID
- PPLS-2173
- Conditions
- Sepsis
- Keywords
- PCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2025 (actual)
- 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.
Procalcitonin (PCT) has been widely used in the diagnosis and treatment of bacterial infectious diseases in China. The investigators aim to establish an algorithm based on BRAHMS PCT (VIDAS PCT) for patients with severe infections or sepsis in the EICU to reduce antibiotic exposure and verify its validity in the reduction of antibiotic exposure, clinical outcomes and costs saving.
Detailed description
This is a multi-center prospective study that will establish 9 centers. Based on preliminary on-site assessments, the centers will be grouped into two arms (SOC group and PCT group) according to their capacity for daily monitoring of PCT. Each center will enroll EICU patients with severe infections or sepsis who meet the inclusion and exclusion criteria. A total of 800 patients will be enrolled, with 400 in the PCT group and 400 in the SOC group. In the PCT group, clinicians will prescribe PCT tests every day for enrolled patients, with assigning a dedicated person monitoring the daily PCT results. Once the PCT <0.5 ng/ml or ΔPCT (drop from the peak value) >80%, the clinicians will receive a notification and will strictly adhere to guidelines and PCT values to adjust antibiotic prescriptions. The SOC group will not have any intervention regarding PCT prescriptions and antibiotic adjustments. The clinicians in the SOC group will prescribe PCT at routine frequency (usually once every 2-3 days or even longer) and adjust or discontinue antibiotics according to guidelines and their experiences. The primary and secondary endpoints will be evaluated in both groups. The primary endpoint is the total duration of antibiotic use. The secondary endpoints are the length of EICU stay and the total length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT group | Experimental | Device: PCT detectionIn the PCT group, clinicians will prescribe PCT tests every day for enrolled patients, with assigning a dedicated person monitoring the daily PCT results. |
| SOC group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥18
- Suspected or confirmed bacterial patients
- Stay EICU more than 3 days
Key exclusion criteria (6 listed)
- age under 18 years;
- PCT concentration throughout the entire hospitalization less than 0.5 ng/ml ;
- known pregnancy; expected stay in the EICU less than 3 days;
- bone-marrow transplant or chemotherapy-induced neutropenia (<500 neutrophils per mL);
- infections for which long-term antibiotic treatment is strongly recommended (ie, infective endocarditis, osteoarticular infections, anterior mediastinitis after cardiac surgery, hepatic or cerebral abscesses, chronic prostatitis, or infection with Mycobacterium tuberculosis, Pneumocystis jirovecii, or Toxoplasma gondii);
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 |
|---|---|---|
| PCT detectionClinicians will prescribe PCT tests every day for enrolled patients, with assigning a dedicated person monitoring the daily PCT results. Once the PCT <0.5 ng/ml or ΔPCT (drop from the peak value) >80%, the clinicians will receive a notification and will strictly adhere to guidelines and PCT values to adjust antibiotic prescriptions. | Device | PCT group |
Primary outcome
Total duration of antibiotics use
Time frame: From the day the patient was admitted to the EICU until the patient left the EICU, calculate how many days were antibiotics used.
1 secondary outcome
Total length of hospital stay (calculated in days)
Time frame: The calculation starts from the first day the patient is admitted to the EICU and extends to the day the patient is discharged (including the possibility of the patient being transferred from the EICU to other departments).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Results publication: PubMed 34510501Austin PC. Informing power and sample size calculations when using inverse probability of treatment weighting using the propensity score. Stat Med. 2021 Nov 30;40(27):6150-6163. doi: 10.1002/sim.9176. Epub 2021 Sep 12.
- Results publication: PubMed 31013271Mewes JC, Pulia MS, Mansour MK, Broyles MR, Nguyen HB, Steuten LM. The cost impact of PCT-guided antibiotic stewardship versus usual care for hospitalised patients with suspected sepsis or lower respiratory tract infections in the US: A health economic model analysis. PLoS One. 2019 Apr 23;14(4):e0214222. doi: 10.1371/journal.pone.0214222. eCollection 2019.
- Results publication: PubMed 34778793Chow J, Markossian TW, Albarillo FS, Donahey EE, Bobay KL. Impact of a Procalcitonin-Based Protocol on Antibiotic Exposure and Costs in Critically Ill Patients. Crit Care Explor. 2021 Nov 9;3(11):e0571. doi: 10.1097/CCE.0000000000000571. eCollection 2021 Nov.
- Results publication: PubMed 29869120Hohn A, Balfer N, Heising B, Hertel S, Wiemer JC, Hochreiter M, Schroder S. Adherence to a procalcitonin-guided antibiotic treatment protocol in patients with severe sepsis and septic shock. Ann Intensive Care. 2018 Jun 4;8(1):68. doi: 10.1186/s13613-018-0415-5.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCT detection in people with Sepsis, run by China-Japan Friendship Hospital at 1 site in China.
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 3 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: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration of antibiotics use (time frame: From the day the patient was admitted to the EICU until the patient left the EICU, calculate how many days were antibiotics used.). 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 NCT06945510, which also lists 4 linked publications.
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 25 Apr 2025.