Status:

COMPLETED

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

Lead Sponsor:

Mahidol University

Conditions:

Sepsis

Septic Shock

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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. Ho...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 27 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2018

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT03344627

Start Date

November 27 2017

End Date

December 31 2018

Last Update

March 12 2019

Active Locations (1)

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1

Faculty of Medicine Ramathibodi Hospital

Ratchathewi, Bangkok, Thailand, 10400