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NCT Number: NCT03452839

Bolus Versus Continuous Infusion of Meropenem

This study arises from the need to optimize antibacterial drug usage to face increasing drug resistance among gram-negative pathogens in intensive care units. Gram-negative organisms are responsible for 70% of drug-resistant infections acquired in the intensive care unit. Meropenem is a β-lactam, carbapenem, antibacterial agent usually administered by intermittent infusion. As β-lactam efficacy is determined by the time in which the drug concentration exceeds the minimum inhibiting concentration of the target pathogen, intermittent infusion of this short half-lived drug can lead to precipitous drops in serum drug levels, an occurrence linked to emergence of resistant pathogens. The investigators hypothesize a beneficial effect of a continuous meropenem infusion on mortality and emergence of drug resistant pathogens. All patients enrolled will receive 1 g of meropenem bolus. After that, subjects will be randomized to receive a continuous infusion of study drug 3g/day or a bolus administration of the same amount of drugs. The investigators expect a reduction of mortality and emergence of extensive or pan drug resistant pathogens from 52 to 40% in the continuous infusion group.

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Key information

Conditions

Antibiotic Resistant Infection Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Dubrava, Dubrava, Croatia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Will be enrolled patients who:

  • Are able to express informed consent or the latter can be given by his/her next of kin or as requested by Ethical Committee.
  • Need a new antibiotic treatment, by clinical judgment, with meropenem
  • Are admitted to ICU
  • Have Sepsis or septic shock. Sepsis defined as having all the following 1. SIRS (Systemic Inflammatory Response Syndrome); 2. suspected or documented infection; 3. a SOFA score ≥ 2. Septic shock defined as having all the following 1.Sepsis; 2. Persisting hypotension requiring vasopressors to maintain MAP ≥65mmHg and having a serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation.

Exclusion criteria

Will be excluded patients who:

  • Are able to express informed consent and deny it
  • Are already receiving study drug or other carbapenem both as a bolus or continuous infusion
  • Have a known allergy or intolerance to study drug, to other carbapenem antibacterial agents or severe allergic reaction to β-lactam antibacterial agents or to anhydrous sodium carbonate (study drug excipient)
  • Have a little chance of survival, as defined by a SAPS II score greater than 65
  • Have concomitant acquired immunodeficiency syndrome (stage 3 according to CDC)
  • Received immunosuppressant or long-term corticosteroid therapy (more than 0.5 mg/kg/day for over 30 days)

Treatment and study plan

Meropenem

Drug

Meropenem or injection vials to be re-constituted in a solution of NaCl 0.9%.

Primary outcomes

  1. Death or Emergence of new resistant bacteria

    Time frame: day 28

    composite outcome:

    • death from any cause at day 28
    • emergence of new XDR (extended drug resistant) or PDR (pan drug resistant) bacteria at day 28

Secondary outcomes

  1. Death from any cause

    Time frame: day 90

    Death from any cause

  2. Antibiotic-free days

    Time frame: up to day 28 or death

    Proportion of days from randomization to day 28 or death in which subject didn't receive any antibiotics (excluding anti-fungal anti-viral drugs)

  3. ICU - free days

    Time frame: day 28 or death

    Number of days from randomization to day 28 (or death) in which the subject is outside the ICU. For any discharge lasting less than 48h, no ICU-free day will be computed. Re-admission lasting less than 24 hours will not reduce ICU-free days. Patients that will not survive outside ICU for at least 48 hours, will have a ICU-free day of zero

  4. Cumulative SOFA-free point

    Time frame: up to day 28

    SOFA score will be evaluated every day up to day 28. SOFA-free daily score is 24 (maximum SOFA) minus actual SOFA. Cumulative SOFA-free is the sum of SOFA-free daily from randomization to date 28. Patients dead before day 28 can't ameliorate their SOFA-free score. This way, the higher the cumulative SOFA-free, the higher is the amelioration of the patient and his probability of survival.

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

Continuous Infusion Versus Intermittent Administration of Meropenem in Critically Ill Patients: A Multicenter Randomized Double Blind Trial

Acronym: MERCY

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2018
Registry last updated
Aug 6, 2025

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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