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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)

Overall Status

Recruiting

CT.gov ID

NCT05762094

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

110.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections

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

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Mortality [January 2018-December 2021]
30-day mortality and 90-day mortality
Attainment of Target Trough Concentration [January 2018-December 2021]
Attainment of Target Trough Concentration

Secondary Outcome Measures

Proportion of patients reach clinical response at end of treatment [January 2018-December 2021]
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
Proportion of patients reach clinical response at day 4 of treatment [January 2018-December 2021]
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
Daily Sequential Organ Failure Assessment score change [January 2018-December 2021]
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.
Incidence of Septic Shock [January 2018-December 2021]
Incidence of Septic Shock
Safety outcome measures [January 2018-December 2021]
Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of carbapenems

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

ClinicalTrials.gov Identifier:

NCT05762094

Other Study ID Numbers:

2022-504-01

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 15, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Carbapenem

Bacterial Infections

Additional relevant MeSH terms:

Infections

Bacterial Infections

Study Results

No Results Posted as of Mar 15, 2023