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

NCT ID: NCT06666998

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-11-01

Brief Summary

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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

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Conditions

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Eravacycline Pharmacokinetics Bacteria Infection Bacterial Resistance to Antimicrobial Empirical Antimicrobial Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lingai Pan

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Lingai Pan

Role: CONTACT

+8617708130236

Other Identifiers

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LPan2

Identifier Type: -

Identifier Source: org_study_id

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