Short-course Antimicrobial Therapy in Sepsis
- Registration Number
- NCT02899143
- Lead Sponsor
- Ospedale Santa Maria delle Croci
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
- Patients who received antibiotics for presumed infection
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 10-days Antibiotic 10-days targeted antibiotic therapy Group 5-days Antibiotic 5-days targeted antibiotic therapy
- Primary Outcome Measures
Name Time Method sepsis-related organ dysfunction 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 Outcome Measures
Name Time Method Hospital mortality 30-days In hospital mortality rate
Trial Locations
- Locations (4)
Ospedale Umberto I
🇮🇹Lugo, Ravenna, Italy
Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce
🇮🇹Cuneo, Italy
ASST Fatebenefratelli Sacco
🇮🇹Milano, Italy
Ospedale Santa Maria Delle Croci
🇮🇹Ravenna, Italy
Ospedale Umberto I🇮🇹Lugo, Ravenna, Italy