PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients

• Conditions: Critical Illness; Bacterial Infections
• Interventions: Drug: Meropenem; Drug: Imipenem

• Registration Number: NCT03858387
• Lead Sponsor: Prince of Songkla University

Brief Summary

Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-02-24
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-05-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• age >18 years
• severely ill patient who admitted to medical or surgical intensive care unit who require a treatment with meropenem or imipenem antibiotic

Exclusion Criteria

• severe renal impairment and require renal replacement therapy
• APACHE II score >30
• History of hypersensitivity to carbapenems
• Pregnancy or breast-feeding female

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Meropenem	Meropenem	Critically ill patients who require meropenem therapy
Imipenem	Imipenem	Critically ill patients who require imipenem therapy

Primary Outcome Measures

Name	Time	Method
Population pharmacokinetic parameters of meropenem and imipenem	24-48 hours after treatment
%fT>MIC of meropenem and imipenem	24-48 hours after treatment	the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT\>MIC)

Secondary Outcome Measures

Name	Time	Method
The relationship between %fT>MIC and mortality	during hospital stay and at day 28	All-cause mortality
The relationship between %fT>MIC and clinical cure	Day 3-7 after treatment and end of therapy (7-14)	Clinical cure: disappearance of all signs and symptoms related to the infection, such that no additional antibacterial therapy, drainage, or surgical procedure was required.
The relationship between %fT>MIC and microbiological cure	Day 3-7 after treatment and end of therapy (7-14)	Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure).

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University, Thailand; 🇹🇭 Hat Yai, Songkla, Thailand