Continuous infusion versus intermittent administration of meropenem in critically ill patients. A multicenter randomized double blind trial.
- 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.MedDRA version: 20.0Level: LLTClassification code 10062357Term: SIRSSystem Organ Class: 100000004867Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-002052-24-IT
- Lead Sponsor
- OSPEDALE SAN RAFFAELE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
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
F.1.3.1 Number of subjects for this age range 300
.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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: reducing death and emergence of extensive or pan drug resistant pathogens in a population of severely ill patients;Secondary Objective: reducing long-term mortality, days under mechanical ventilation, intensive care unit length of stay, fastening reduction of severity of disease.;Primary end point(s): reducing death and emergence of extensive or pan drug resistant pathogens in a population of severely ill patients;Timepoint(s) of evaluation of this end point: 28 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): reducing long-term mortality, days under mechanical ventilation, intensive care unit length of stay, fastening reduction of severity of disease.;Timepoint(s) of evaluation of this end point: 90 days