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

Sichuan Provincial People's Hospital

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06666998

LPan2

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.