Prolonged Intravenous Infusion of β-lactam Antibiotics in Early Septic Patients

NCT05024565 | Unknown

• 1 other identifier: Wang Hao
• Study Type: interventional
• Target: 2,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The prolonged β-lactam Antibiotics intravenous infusion strategy has emerged as the standard treatment for sepsis despite its unknown efficacy. The investigators will conduct a prospective, multi-center, cluster randomized controlled clinical trial. The investigators aimed to compare the clinical efficacy and prognosis of prolonged β-lactam antibiotics intravenous infusion versus short-term intravenous infusion in ICU patients with early sepsis. The investigators expect to recruit 40 branch centers and enroll at least 2600 patients with sepsis.

Conditions

Sepsis

Keywords

prolonged intravenous infusion; β-lactam Antibiotics; pharmacokinetics/pharmacodynamics (PK/PD)

Outcome Measures

Primary Outcomes (2)

• All-cause mortality in ICU

  Prolonged β-lactamase Antibiotics Infusion lower the All-cause mortality in ICU compared with normal group

  Change of mortality between two arms at 90-day from the day antibiotic therapy begin.

• 28-day all-cause mortality

  Prolonged β-lactamase Antibiotics Infusion lower 28-day all-cause mortality the compared with normal group

  Change of mortality between two arms at 28-day from the day antibiotic therapy begin.

Study Arms (2)

prolonged intravenous infusion of β-lactams Antibiotics

EXPERIMENTAL

Administer according to the PK/PD optimized regimen with the goal of increasing T\>MIC. (1) Carbapenems: Calculate the daily dose according to the creatinine clearance rate and divide it into 3 times. Each time, the dose is injected intravenously at 1/2 dose for 15 minutes, and the remaining 1/2 dose is injected at a constant rate for 3 hours. (2) Cephalosporins: calculate the allowable daily dose according to the creatinine clearance rate, inject at a uniform rate within 24 hours. (3) β-lactams and β-lactamase inhibitor compound: the daily dose is calculated according to the creatinine clearance rate and injected at a uniform rate within 24 hours.

Behavioral: prolonged intravenous infusion of β-lactams Antibiotics

short-term intravenous infusion of β-lactams Antibiotics

NO INTERVENTION

The daily allowable dose is calculated according to the creatinine clearance rate. The carbapenems, cephalosporins and β-lactamase inhibitor compound preparations are administered in accordance with the dosage and usage required by the instructions, and the injection is generally 30 minutes.

Interventions

prolonged intravenous infusion of β-lactams Antibiotics BEHAVIORAL

(1) Carbapenems: Calculate the daily dose according to the creatinine clearance rate and divide it into 3 times. Each time, the dose is injected intravenously at 1/2 dose for 15 minutes, and the remaining 1/2 dose is injected at a constant rate for 3 hours. (2) Cephalosporins: calculate the allowable daily dose according to the creatinine clearance rate, inject at a uniform rate within 24 hours. (3) β-lactams and β-lactamase inhibitor compound: the daily dose is calculated according to the creatinine clearance rate and injected at a uniform rate within 24 hours.

prolonged intravenous infusion of β-lactams Antibiotics

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in ICU who need to be treated with β-lactam antibiotics for clinical diagnosis of infection;
• Meet the diagnostic criteria of sepsis 3.0 in the previous 24h;
• At assessment of eligibility, treating doctor expects patient to need treatment in ICU beyond the next calendar day.

You may not qualify if:

• The infection is diagnosed clinically, but the acquired pathogens are not sensitive to the study drug;
• Has a history of allergies to study drugs;
• Those who have a serious condition and the expected survival time is less than 72 hours.
• Receipt of potential study medication for \> 24 hours before randomization.
• Pregnancy
• Death is deemed imminent and inevitable.
• Receiving palliative or supportive treatment only at the time of assessment for eligibility.
• Treating doctor not committed to provision of advanced life-support, including any of mechanical ventilation, dialysis and vasopressor administration for at least the next 48 hours.
• Consent not gained for study participation and entry under a waiver-of-consent not approved by the jurisdictional human research ethics committee.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 27, 2021
• Study Start: September 20, 2021
• Primary Completion: December 31, 2022
• Study Completion: September 1, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study protocol and ICF will be shared with other researchers when start this trial for five years.
• Access Criteria: Ever researchers can access our study protocol and ICF from the web of clinical trials.gov.