Short-course Antimicrobial Therapy in Sepsis

Ospedale Santa Maria delle Croci320 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

320

Conditions

Infection Sepsis Severe Sepsis Septic Shock

Interventions

AntibioticDRUG

Targeted antimicrobial therapy

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (4)

Ospedale Umberto I

Lugo, Ravenna, Italy

RECRUITING

Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce

Cuneo, Italy

RECRUITING

ASST Fatebenefratelli Sacco

Milan, Italy

RECRUITING

Outcomes

Primary Outcomes

sepsis-related organ dysfunction

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.

Time frame: 14-days

Secondary Outcomes

Hospital mortality

In hospital mortality rate

Time frame: 30-days

Central Contacts

Vincenzo De Santis

CONTACT

vincenzo.desantis@auslromagna.it

Data from ClinicalTrials.gov

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