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

NCT06666998 | Not Yet Recruiting

• 1 other identifier: LPan2
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Clinical remission rate

  Completion of scheduled course of treatment; ≤14 days of treatment; treatment not restarted within 48 hours of discontinuation

  At the end of treatment；2 weeks（estimated）

• Microbiological efficacy

  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)

  From enrollment to the end of treatment at 28 days

Secondary Outcomes (1)

• Develop Population Pharmacokinetic Model

  From enrollment to the end of treatment at 28 days

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 critically infected patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Central Study Contacts

Lingai Pan

CONTACT

+8617708130236; panlingai2004@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 31, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-10