NCT03452839

Bolus Versus Continuous Infusion of Meropenem

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antibiotic Resistant Infection
• Critical Illness

Interventions

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

Timeline

• Start date: 2018-06-05
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2018-03-02
• Last updated: 2025-08-06

Locations

26 sites across 4 countries: Croatia, Italy, Kazakhstan, Russia