PCT Guided Antibiotics Use in Critically Ill Adult Patients in China
April 18, 2025 updated by: YAN Shengtao, China-Japan Friendship Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Estimated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China, 100029
- China-Japan Friendship Hospital
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Contact:
- Shengtao YAN
- Phone Number: 0086-010-84205566
- Email: yanshengtaozrr@126.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age≥18
- Suspected or confirmed bacterial patients
- Stay EICU more than 3 days
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PCT 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.
|
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.
|
|
No Intervention: SOC group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
From the day the patient was admitted to the EICU until the patient left the EICU, calculate how many days were antibiotics used.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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).
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Mewes 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.
- Chow 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.
- Hohn 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 30, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
April 14, 2025
First Submitted That Met QC Criteria
April 18, 2025
First Posted (Actual)
April 25, 2025
Study Record Updates
Last Update Posted (Actual)
April 25, 2025
Last Update Submitted That Met QC Criteria
April 18, 2025
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPLS-2173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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