Status:
COMPLETED
Bolus Versus Continuous Infusion of Meropenem
Lead Sponsor:
Università Vita-Salute San Raffaele
Conditions:
Antibiotic Resistant Infection
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 f...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT03452839
Start Date
June 5 2018
End Date
December 1 2022
Last Update
August 6 2025
Active Locations (26)
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1
University Hospital Dubrava
Dubrava, Croatia
2
Città di Lecce Hospital
Lecce, Apulia, Italy
3
ASST Cremona
Cremona, Cemona, Italy
4
Policlinico Univeristario Campus Bio-Medico
Rome, Lazio, Italy