A Retrospective Study on Personalized Dosing Strategy of Patients With Bacterial Infections Treated by Carbapenems From a Tertiary Medical Center During 2018-2021
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Attainment of Target Trough Concentration
Study Overview
Brief Summary
Patients may benefit from the personalized carbapenem dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review and analyze the clinical outcomes of patients with different dosing strategy.
Detailed Description
Rational use of carbapenem is closely associated with the clinical outcome of patients with infections. Serum concentration of carbapenem varies from different populations. The objective of this study is to describe the clinical outcome of patients with infection treated by carbapenem in China, regarding diagnosis, treatment and follow-up. It is a single-center, retrospective, descriptive study. Inclusion criteria are an age ≥ 18, diagnosed as bacteria infection and serum concentration must be determined during therapy. Data concerning clinical presentation, biological samples, treatment and follow-up will be assessed. A descriptive analysis will be performed.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age over 18 years Chinese patient: male or female Diagnosed as bacterial infection Treated by carbapenem Serum concentration determined during therapy
Exclusion Criteria
- •Duration of carbapenem treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of carbapenem
Outcomes
Primary Outcomes
Attainment of Target Trough Concentration
Time Frame: January 2018-December 2021
Attainment of Target Trough Concentration
Mortality
Time Frame: January 2018-December 2021
30-day mortality and 90-day mortality
Secondary Outcomes
- Incidence of Septic Shock(January 2018-December 2021)
- Safety outcome measures(January 2018-December 2021)
- Proportion of patients reach clinical response at end of treatment(January 2018-December 2021)
- Proportion of patients reach clinical response at day 4 of treatment(January 2018-December 2021)
- Daily Sequential Organ Failure Assessment score change(January 2018-December 2021)