PCT Guided Antibiotics Use in Critically Ill Adult Patients in China

NCT06945510 | Not Yet Recruiting

• 1 other identifier: PPLS-2173
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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 reduction of antibiotic exposure, clinical outcomes and costs saving.

Conditions

Sepsis

Keywords

PCT

Outcome Measures

Primary Outcomes (1)

• Total duration of antibiotics use

  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)

  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).

Study Arms (2)

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.

Device: PCT detection

SOC group

NO INTERVENTION

Interventions

PCT detection DEVICE

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.

PCT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18
• Suspected or confirmed bacterial patients
• Stay EICU more than 3 days

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 100029, China

Location

Related Publications (4)

• 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.

  PMID: 34510501 BACKGROUND

• 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.

  PMID: 31013271 BACKGROUND

• 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.

  PMID: 34778793 BACKGROUND

• 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.

  PMID: 29869120 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Emergency Department

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 25, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)