Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients

Mahidol University

Status

Completed

Conditions

Clinical Outcome

Pharmacodynamic

Pharmacokinetic

Morality

Organ Failure, Multiple

Critical Illness

Carbapenem

Septic Shock

Sepsis

Treatments

Drug: Meropenem standard dose

Drug: Meropenem high dose

Study type

Interventional

Funder types

Other

Identifiers

NCT03344627

ID07-60-19

Details and patient eligibility

About

Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults (18 years and older) with sepsis and/or septic shock according to SEPSIS-3 criteria and receive meropenem within 1 hour after diagnosis
Informed consent signed by patient or their legally authorized representative

Exclusion criteria

Subjects with infective endocarditis
Subjects with central nervous system infection
Subjects who requires surgical condition within 72 hours after randomization
Subjects on extracorporeal membrane oxygenation (ECMO) within 3 days after randomization
Subjects with active seizure
History of receiving meropenem within 1 week prior to randomization
Pregnancy women and lactation
Known allergy to meropenem
Not complete a 72-hour course of empirical meropenem treatment