Bolus Versus Continuous Infusion of Meropenem (MERCY)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    600
  • sponsor
    Università Vita-Salute San Raffaele
Updated on 27 February 2022

Summary

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.

Details
Condition Antibiotic Resistant Infection, Critical Illness
Treatment Meropenem
Clinical Study IdentifierNCT03452839
SponsorUniversità Vita-Salute San Raffaele
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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