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Short-course Antimicrobial Therapy in Sepsis

Primary Purpose

Infection, Sepsis, Severe Sepsis

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Antibiotic
Sponsored by
Ospedale Santa Maria delle Croci
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ospedale Umberto IRecruiting
  • Azienda Ospedaliera S.Croce e Carle - Ospedale S.CroceRecruiting
  • ASST Fatebenefratelli SaccoRecruiting
  • Ospedale Santa Maria Delle CrociRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group 5-days

Group 10-days

Arm Description

5-days targeted antibiotic therapy

10-days targeted antibiotic therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hospital mortality
In hospital mortality rate

Full Information

First Posted
September 8, 2016
Last Updated
September 7, 2021
Sponsor
Ospedale Santa Maria delle Croci
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1. Study Identification

Unique Protocol Identification Number
NCT02899143
Brief Title
Short-course Antimicrobial Therapy in Sepsis
Official Title
Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Santa Maria delle Croci

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Sepsis, Severe Sepsis, Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 5-days
Arm Type
Experimental
Arm Description
5-days targeted antibiotic therapy
Arm Title
Group 10-days
Arm Type
Other
Arm Description
10-days targeted antibiotic therapy
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
Targeted antimicrobial therapy
Primary Outcome Measure Information:
Title
sepsis-related organ dysfunction
Description
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 Outcome Measure Information:
Title
Hospital mortality
Description
In hospital mortality rate
Time Frame
30-days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo De Santis
Email
vincenzo.desantis@auslromagna.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo De Santis
Organizational Affiliation
Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Umberto I
City
Lugo
State/Province
Ravenna
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico Vitale, MD
Email
dovitale@hotmail.com
Facility Name
ASST Fatebenefratelli Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Corona
Email
alberto.corona@asst-fbt-sacco.it
Facility Name
Ospedale Santa Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Fusari

12. IPD Sharing Statement

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Short-course Antimicrobial Therapy in Sepsis

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