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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Direct Antimicrobial Susceptibility Testing on Respiratory Sample of Intensive Care Patient With Suspected VAP

NCT02897466

Ventilator-associated Pneumonia

UNKNOWN NA

Pilot Study of the Utility of Empiric Antibiotic Therapy for Suspected ICU-Acquired Infection

NCT00438269

Nosocomial Infection Pneumonia Systemic Inflammatory Response Syndrome +2 more

COMPLETED PHASE2

The Pharmacodynamics of Meropenem in Patient With Ventilator-associated Pneumonia

NCT02615041

Ventilator-Associated Pneumonia

COMPLETED PHASE4

Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

NCT02728518

Pneumonia

COMPLETED NA

Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria

NCT04839653

Pneumonia, Ventilator-Associated Pneumonia Bloodstream Infection +4 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Bacterial Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Meropenem

Critically ill patients who require meropenem therapy

Meropenem

Intervention Type 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.

Imipenem

Critically ill patients who require imipenem therapy

Imipenem

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Imipenem/cilastatin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No