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

Prince of Songkla University

Status: Unknown

Conditions: Critical Illness; Bacterial Infections

Treatments: Drug: Imipenem; Drug: Meropenem

Study type: Observational

Funder types: Other

Identifiers

NCT03858387

B-lactams-ICU-61061141

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

102 participants in 2 patient groups

Meropenem

Description:

Critically ill patients who require meropenem therapy

Treatment:

Drug: Meropenem

Imipenem

Description:

Critically ill patients who require imipenem therapy

Treatment:

Drug: Imipenem