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A Retrospective Study on Personalized Dosing Strategy of Patients Treated by Carbapenems: 2018-2021

A Retrospective Study on Personalized Dosing Strategy of Patients With Bacterial Infections Treated by Carbapenems From a Tertiary Medical Center During 2018-2021

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05762094
Enrollment
1000
Registered
2023-03-09
Start date
2023-03-31
Completion date
2023-12-31
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Keywords

Carbapenem, Bacterial Infections

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.

Interventions

None listed

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
MortalityJanuary 2018-December 202130-day mortality and 90-day mortality
Attainment of Target Trough ConcentrationJanuary 2018-December 2021Attainment of Target Trough Concentration

Secondary

MeasureTime frameDescription
Daily Sequential Organ Failure Assessment score changeJanuary 2018-December 2021Sequential Organ Failure Assessment score (Range from 0-24), lower score means a better outcome. Increase of 2 points within 48 hours means the presence of sepsis.
Proportion of patients reach clinical response at end of treatmentJanuary 2018-December 2021By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12\*10\^9/L or less than 4\*10\^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms
Safety outcome measuresJanuary 2018-December 2021Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of carbapenems
Incidence of Septic ShockJanuary 2018-December 2021Incidence of Septic Shock
Proportion of patients reach clinical response at day 4 of treatmentJanuary 2018-December 2021By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12\*10\^9/L or less than 4\*10\^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026