Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care
Overview
- Phase
- Phase 2
- Intervention
- Antibiotic
- Conditions
- Infection
- Sponsor
- Ospedale Santa Maria delle Croci
- Enrollment
- 320
- Locations
- 4
- Primary Endpoint
- sepsis-related organ dysfunction
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.
Investigators
Vincenzo De Santis
Medical Doctor
Ospedale Santa Maria delle Croci
Eligibility Criteria
Inclusion Criteria
- •Patients who received antibiotics for presumed infection
Exclusion Criteria
- •Prolonged therapy (eg, endocarditis)
- •Severe immunosuppression
- •Severe infections (due to viruses, parasites, or Mycobacterium tuberculosis)
- •Patients previously infected or colonized with multidrug resistant pathogens and moribund patients.
Arms & Interventions
Group 5-days
5-days targeted antibiotic therapy
Intervention: Antibiotic
Group 10-days
10-days targeted antibiotic therapy
Intervention: Antibiotic
Outcomes
Primary Outcomes
sepsis-related organ dysfunction
Time Frame: 14-days
Score used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The Sequential Organ Failure Assessment (SOFA) score numerically quantifies the number and severity of failed organs. Higher values represent worse outcome. A score of 0 is given for normal function through to 4 for most abnormal. The systems studied are: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal.
Secondary Outcomes
- Hospital mortality(30-days)