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

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Meropenem; Thienamycins

Criteria

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