An interventional study of Meropenem standard dose and Meropenem high dose in Sepsis, Septic Shock and Critical Illness, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
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
Exclusion Criteria:
Meropenem 1 g every 8 hours
Drug: Meropenem standard dose
Meropenem 2 g every 8 hours
Drug: Meropenem high dose
* Empirical with 1 g meropenem intravenous infusion in 30 minutes then 1 g intravenous infusion in 3 hours every 8 hours. * Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection.
* Empirical with 2 g meropenem intravenous infusion in 30 minutes then 2 g intravenous infusion in 3 hours every 8 hours. * Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection
SOFA score change
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
Time frame: Change from Baseline SOFA score at day 4
Mortality
In hospital mortality
Time frame: 14 and 28 days
Clinical cure
Composite of: 1. Persistent fever and/or 2. Stable or increased white blood cell count
Time frame: Day 3, 5, 7, 10 and 14
Microbiological cure
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
Time frame: Day 3, 5, 7, 10 and 14
Duration of vasopressor agents
Time interval (day) from time of vasopressor agents initiation to time to vasopressor agents discontinuation
Time frame: 14 and 28 days
Duration of mechanical ventilator
Time interval (day) of mechanical ventilator
Time frame: 14 and 28 days
Length of ICU stay
Time interval (day) from ICU admission (after randomization) to ICU discharge
Time frame: 14 and 28 days
Length of hospital stay
Time interval (day) from hospital admission (after randomization) to hospital discharge
Time frame: 14 and 28 days
%T > MIC
% time of meropenem concentration above MIC
Time frame: Day 1
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mahidol University