Short-course Antimicrobial Therapy in Sepsis

September 7, 2021 updated by: Vincenzo De Santis, Ospedale Santa Maria delle Croci

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Cuneo, Italy, 12100
        • Recruiting
        • Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce
        • Contact:
      • Milano, Italy, 20157
      • Ravenna, Italy, 48121
        • Recruiting
        • Ospedale Santa Maria delle Croci
        • Contact:
          • Maurizio Fusari
    • Ravenna
      • Lugo, Ravenna, Italy
        • Recruiting
        • Ospedale Umberto I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 5-days
5-days targeted antibiotic therapy
Drug: Antibiotic
Targeted antimicrobial therapy
OTHER: Group 10-days
10-days targeted antibiotic therapy
Drug: Antibiotic
Targeted antimicrobial therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: 30-days
In hospital mortality rate
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Maria delle Croci

Investigators

  • Principal Investigator: Vincenzo De Santis, Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (ESTIMATE)

September 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1599

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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