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

Critical Illness Clinical Trial

Official title:

Pharmacokinetics/Pharmacodynamics and Clinical Outcomes of β-lactams in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858387
• Other study ID #: B-lactams-ICU-61061141
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2020
• Source: Prince of Songkla University
• Contact: Sutep o Jaruratanasirikul, M.D.
• Phone: 6674451485
• Email: jasutep[@]medicine.psu.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Critical Illness

Intervention

Drug:
• Meropenem
This group is composed of 52 critically ill patients, meropenem dosage is chosen by the intensivist in charge of the case. Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2.5 h, 2.5-4 h, 4-8 h or 4-12 after meropenem administration.
• Imipenem
This group is composed of 50 critically ill patients, imipenem dosage is chosen by the intensivist in charge of the case. Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2 h, 2-4 h, 4-6 h or 4-12 after imipenem administration.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University, Thailand	Hat Yai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population pharmacokinetic parameters of meropenem and imipenem		24-48 hours after treatment
Primary	%fT>MIC of meropenem and imipenem	the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT>MIC)	24-48 hours after treatment
Secondary	The relationship between %fT>MIC and clinical cure	Clinical cure: disappearance of all signs and symptoms related to the infection, such that no additional antibacterial therapy, drainage, or surgical procedure was required.	Day 3-7 after treatment and end of therapy (7-14)
Secondary	The relationship between %fT>MIC and microbiological cure	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).	Day 3-7 after treatment and end of therapy (7-14)
Secondary	The relationship between %fT>MIC and mortality	All-cause mortality	during hospital stay and at day 28