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Completed

NCT Number: NCT03344627

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

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

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Key information

Conditions

Sepsis Carbapenem Clinical Outcome Critical Illness Disease Attributes Infections Inflammation Morality Multiple Organ Failure Organ Failure, Multiple Pathologic Processes Pathological Conditions, Signs and Symptoms Pharmacodynamic Pharmacokinetic Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ramathibodi Hospital

Ratchathewi, Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem standard dose

Drug
  • 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.

Meropenem high dose

Drug
  • 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

Primary outcomes

  1. SOFA score change

    Time frame: 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 outcomes

  1. Mortality

    Time frame: 14 and 28 days

    In hospital mortality

  2. Clinical cure

    Time frame: Day 3, 5, 7, 10 and 14

    Composite of:

    • Persistent fever and/or
    • Stable or increased white blood cell count

  3. Microbiological cure

    Time frame: 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

  4. Duration of vasopressor agents

    Time frame: 14 and 28 days

    Time interval (day) from time of vasopressor agents initiation to time to vasopressor agents discontinuation

  5. Duration of mechanical ventilator

    Time frame: 14 and 28 days

    Time interval (day) of mechanical ventilator

  6. Length of ICU stay

    Time frame: 14 and 28 days

    Time interval (day) from ICU admission (after randomization) to ICU discharge

  7. Length of hospital stay

    Time frame: 14 and 28 days

    Time interval (day) from hospital admission (after randomization) to hospital discharge

  8. %T > MIC

    Time frame: Day 1

    % time of meropenem concentration above MIC

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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