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

NCT05762094 | Unknown DMC

• 1 other identifier: 2022-504-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections

Keywords

Carbapenem; Bacterial Infections

Outcome Measures

Primary Outcomes (2)

• Mortality

  30-day mortality and 90-day mortality

  January 2018-December 2021

• Attainment of Target Trough Concentration

  Attainment of Target Trough Concentration

  January 2018-December 2021

Secondary Outcomes (5)

• 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

• Incidence of Septic Shock

  January 2018-December 2021

• Safety outcome measures

  January 2018-December 2021

Study Arms (4)

CAR-R

Patients with impaired renal function (eGFR \< 60ml/min/1.73m2) treated by carbapenem

CAR-L

Patients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by carbapenem

CAR-LR

Patients with co-morbidity of both liver cirrhosis or impaired liver function (Child-Pugh grade B or C) and impaired renal function (eGFR \< 60ml/min/1.73m2) treated by carbapenem

CAR-N

Patients with normal liver function or renal function treated by carbapenem

Eligibility Criteria

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

Study Population

Chinese adult patients with bacterial infections treated by carbapenem

You may qualify if:

• Age over 18 years Chinese patient: male or female Diagnosed as bacterial infection Treated by carbapenem Serum concentration determined during therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-02

Locations

CN (1)