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Clinical Trials/EUCTR2016-002052-24-IT
EUCTR2016-002052-24-IT
Active, not recruiting
Phase 1

Continuous infusion versus intermittent administration of meropenem in critically ill patients. A multicenter randomized double blind trial. - Bolus versus continuous infusion of meropenem.

OSPEDALE SAN RAFFAELE0 sites600 target enrollmentNovember 4, 2020
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ConditionsWe are planning a large multicentre randomized controlled study to confirm the beneficial effect of continuous infusion of meropenem against bolus administration as indicated by a composite outcome of reducing death, and emergence of extensive or pan drug resistant pathogens in a population of severely ill patients.MedDRA version: 20.0Level: LLTClassification code 10062357Term: SIRSSystem Organ Class: 100000004867Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsMerepenem Aurobindo e Merrem di Pfizer (ex Astrazeneca)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
We are planning a large multicentre randomized controlled study to confirm the beneficial effect of continuous infusion of meropenem against bolus administration as indicated by a composite outcome of reducing death, and emergence of extensive or pan drug resistant pathogens in a population of severely ill patients.
Sponsor
OSPEDALE SAN RAFFAELE
Enrollment
600
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 4, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
OSPEDALE SAN RAFFAELE

Eligibility Criteria

Inclusion Criteria

  • •1\. Are at least 18 years old
  • •2\. Need a new antibiotic treatment, by clinical judgment, with meropenem
  • •3\. Are admitted to ICU
  • •4\. Have Sepsis or septic shock
  • •5\. Are able to express informed consent or by him/her next of kin or as requested by Ethical Committee.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 300
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •.1\. Are able to express informed consent and denying it
  • •2\. Are already receiving study drug or other carbapenem both as a bolus or continuous infusion
  • •3\. Have a known allergy or intolerance to study drug
  • •4\. Have a little chance of survival, as defined by a SAPS II score more than 65 point
  • •5\. Have concomitant acquired immunodeficiency syndrome (stage 3 according to CDC)
  • •6\. Have received immunosuppressant or long\-term corticosteroid therapy (more than 0\.5 mg/kg/day for over 30 days)

Outcomes

Primary Outcomes

Not specified

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