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

NCT03858387 | Unknown

• 1 other identifier: B-lactams-ICU-61061141
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Bacterial Infections

Keywords

pharmacokinetics; pharmacodynamics; meropenem; imipenem

Outcome Measures

Primary Outcomes (2)

• Population pharmacokinetic parameters of meropenem and imipenem

  24-48 hours after treatment

• %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 Outcomes (3)

• The relationship between %fT>MIC and clinical cure

  Day 3-7 after treatment and end of therapy (7-14)

• The relationship between %fT>MIC and microbiological cure

  Day 3-7 after treatment and end of therapy (7-14)

• The relationship between %fT>MIC and mortality

  during hospital stay and at day 28

Study Arms (2)

Meropenem

Critically ill patients who require meropenem therapy

Drug: Meropenem

Imipenem

Critically ill patients who require imipenem therapy

Drug: Imipenem

Interventions

Meropenem DRUG

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.

Meropenem

Imipenem DRUG

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.

Also known as: Imipenem/cilastatin

Imipenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of Medicine, Prince of Songkla University, Thailand

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Related Publications (1)

• Jaruratanasirikul S, Boonpeng A, Nawakitrangsan M, Samaeng M. NONMEM population pharmacokinetics and Monte Carlo dosing simulations of imipenem in critically ill patients with life-threatening severe infections during support with or without extracorporeal membrane oxygenation in an intensive care unit. Pharmacotherapy. 2021 Jul;41(7):572-597. doi: 10.1002/phar.2597. Epub 2021 Jun 18.

  PMID: 34080708 DERIVED

MeSH Terms

Conditions

Critical Illness; Bacterial Infections

Interventions

Meropenem; Imipenem; Cilastatin, Imipenem Drug Combination

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Sutep Jaruratanasirikul, M.D.

  Faculty of Medicine, Prince of Songkla University, Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sutep o Jaruratanasirikul, M.D.

CONTACT

6674451485; jasutep@medicine.psu.ac.th

Monchana o Nawakitrangsan, M.Pharm.

CONTACT

6674451485; nana_jittung@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medicine, Faculty of Medicine, Prince of Songkla University

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 28, 2019
• Study Start: September 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

TH (1)