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

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.

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Key information

Conditions

Eravacycline Bacteria Infection Bacterial Resistance to Antimicrobial Empirical Antimicrobial Therapy Pharmacokinetics

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Clinical remission rate

Time frame: 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

Time frame: 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 outcomes

Develop Population Pharmacokinetic Model

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lingai Pan

CONTACT

[email protected]

+8617708130236

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Oct 31, 2024
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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