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

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ClinicalTrials.gov Identifier: NCT03344627
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tospon Lertwattanachai, 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

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Critical Illness Carbapenem Pharmacokinetic Pharmacodynamic Clinical Outcome Organ Failure, Multiple Morality Drug: Meropenem standard dose Drug: Meropenem high dose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
Drug Information available for: Meropenem

Arm Intervention/treatment
Active Comparator: Meropenem standard dose
Meropenem 1 g every 8 hours
Drug: Meropenem standard 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.

Active Comparator: Meropenem high dose
Meropenem 2 g every 8 hours
Drug: Meropenem high dose
  • 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 Outcome Measures :
  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 Outcome Measures :
  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:

    1. Persistent fever and/or
    2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344627


Locations
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Thailand
Faculty of Medicine Ramathibodi Hospital
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Tospon Lertwattanachai, B.sc.(Pharm) Faculty of Pharmacy, Mahidol University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tospon Lertwattanachai, Principal Investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03344627    
Other Study ID Numbers: ID07-60-19
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
Critical Illness
Multiple Organ Failure
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents