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

Not Applicable

Completed

• Conditions: Sepsis; Pharmacokinetic; Pharmacodynamic; Morality; Septic Shock; Critical Illness; Clinical Outcome; Carbapenem; Organ Failure, Multiple
• Interventions: Drug: Meropenem high dose; Drug: Meropenem standard dose

• Registration Number: NCT03344627
• Lead Sponsor: Mahidol University

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. 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Study Start: 2017-11-27
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-09
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meropenem high dose	Meropenem high dose	Meropenem 2 g every 8 hours
Meropenem standard dose	Meropenem standard dose	Meropenem 1 g every 8 hours

Primary Outcome Measures

Name	Time	Method
SOFA score change	Change from Baseline SOFA score at day 4	The Sequential organ failure assessment (SOFA) score describe the time course of multiple organ dysfunction.; The SOFA score is composed of scores for six organ systems (respiratory, cardiovascular, neurological, hepatic, renal and coagulation).; The function of six organ systems is scored from 0 (no organ dysfunction) to 4 (severe organ dysfunction), and the individual organ scores are then summed to a total score between 0 and 24.; Primary outcome is assessing change between SOFA score at baseline and SOFA score at day 4 after treatment by meropenem

Secondary Outcome Measures

Name	Time	Method
Mortality	14 and 28 days	In hospital mortality
Length of hospital stay	14 and 28 days	Time interval (day) from hospital admission (after randomization) to hospital discharge
Duration of mechanical ventilator	14 and 28 days	Time interval (day) of mechanical ventilator
Length of ICU stay	14 and 28 days	Time interval (day) from ICU admission (after randomization) to ICU discharge
%T > MIC	Day 1	% time of meropenem concentration above MIC
Clinical cure	Day 3, 5, 7, 10 and 14	Composite of: 1. Persistent fever and/or; 2. Stable or increased white blood cell count
Microbiological cure	Day 3, 5, 7, 10 and 14	Elimination of the study entry pathogen within 14 days after received meropenem; * Bacteremia: no growth in blood cultures; * Intra-abdominal infection: no growth in blood cultures; * UTI: uropathogen growth of less than 10\^4 CFU/mL in women or less than 10\^3 CFU/mL in men; * HAP/VAP: pathogen in sputum culture growth of less than 10\^3 CFU/mL; * SSTI: no growth in blood cultures
Duration of vasopressor agents	14 and 28 days	Time interval (day) from time of vasopressor agents initiation to time to vasopressor agents discontinuation

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital; 🇹🇭 Ratchathewi, Bangkok, Thailand