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

NCT ID: NCT05762094

Last Updated: 2023-03-15

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CAR-R

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

No interventions assigned to this group

CAR-L

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

No interventions assigned to this group

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

No interventions assigned to this group

CAR-N

Patients with normal liver function or renal function treated by carbapenem

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dayu Chen

Role: primary

+86-025-83106666-60921

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-504-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.