Real-World Pharmacokinetic/Pharmacodynamic Study of Eravacycline in Critically III Patients

Not yet recruiting

• Conditions: Eravacycline; Pharmacokinetics; Bacteria Infection; Bacterial Resistance to Antimicrobial; Empirical Antimicrobial Therapy

• Registration Number: NCT06666998
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

The aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Study Start: 2024-11-01
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult male or female aged 18-75 years
• Not respond to initial empirical treatment, treatment time to reach Eravacycline steady-state concentration
• Empirical antimicrobial treatment is ineffective
• Eravacycline application for ≥ 3 days
• Understand and sign informed consent

Exclusion Criteria

• Urinary tract infection
• Allergic to Eravacycline, Tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions
• Any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient
• Patients expected to survive for no longer than 48h.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical remission rate	At the end of treatment；2 weeks（estimated）	Completion of scheduled course of treatment; ≤14 days of treatment; treatment not restarted within 48 hours of discontinuation
Microbiological efficacy	From enrollment to the end of treatment at 28 days	Evaluate at the end of treatment and at post-treatment (discharge) in patients who met all clinical evaluation criteria and who had positive bacteriologic cultures prior to treatment, and bacterial clearance was calculated using the results of post-treatment follow-up (discharge) as the primary endpoint of evaluation.Performing safety observation (including coagulation dysfunction and other adverse reactions)

Secondary Outcome Measures

Name	Time	Method
Develop Population Pharmacokinetic Model	From enrollment to the end of treatment at 28 days	Initial testing perform at first dose and steady-state testing perform at the seventh dose.Calculation of all-eravacycline fAUC using the linear trapezoidal method.Multiple regression analysis use to generate the best model equation for estimating the fAUC using the concentration of eravacycline at each sampling point in the modeling group as the independent variable and the fAUC as the dependent variable.