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Short-course Antimicrobial Therapy in Sepsis

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02899143
Enrollment
320
Registered
2016-09-14
Start date
2016-09-30
Completion date
2021-10-31
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Sepsis, Septic Shock, Severe Sepsis

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.

Interventions

DRUGAntibiotic

Targeted antimicrobial therapy

Sponsors

Ospedale Santa Maria delle Croci
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
sepsis-related organ dysfunction14-daysScore 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

MeasureTime frameDescription
Hospital mortality30-daysIn hospital mortality rate

Countries

Italy

Contacts

Primary ContactVincenzo De Santis
vincenzo.desantis@auslromagna.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026