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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762094
• Other study ID #: 2022-504-01
• Status: Recruiting
• Start date: March 2023
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Infections

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	30-day mortality and 90-day mortality	January 2018-December 2021
Primary	Attainment of Target Trough Concentration	Attainment of Target Trough Concentration	January 2018-December 2021
Secondary	Proportion of patients reach clinical response at end of treatment	By 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	January 2018-December 2021
Secondary	Proportion of patients reach clinical response at day 4 of treatment	By 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	January 2018-December 2021
Secondary	Daily Sequential Organ Failure Assessment score change	Sequential 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.	January 2018-December 2021
Secondary	Incidence of Septic Shock	Incidence of Septic Shock	January 2018-December 2021
Secondary	Safety outcome measures	Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of carbapenems	January 2018-December 2021