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NCT02899143 Clinical Trial

Short-course Antimicrobial Therapy in Sepsis

Sepsis Clinical Trial

Official title:
Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02899143
Other study ID # 1599
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 2016
Est. completion date October 2021

Study information
Verified date September 2021
Source Ospedale Santa Maria delle Croci
Contact Vincenzo De Santis
Email vincenzo.desantis@auslromagna.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 320
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Antibiotic
Targeted antimicrobial therapy

Locations
Country Name City State
Italy Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce Cuneo
Italy Ospedale Umberto I Lugo Ravenna
Italy ASST Fatebenefratelli Sacco Milano
Italy Ospedale Santa Maria Delle Croci Ravenna

Sponsors (1)
Lead Sponsor Collaborator
Ospedale Santa Maria delle Croci

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 14-days
Secondary Hospital mortality In hospital mortality rate 30-days
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