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Short-course Antimicrobial Therapy in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02899143
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : August 29, 2019
Information provided by (Responsible Party):
Vincenzo De Santis, Ospedale Santa Maria delle Croci

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.

Condition or disease Intervention/treatment Phase
Infection Sepsis Severe Sepsis Septic Shock Drug: Antibiotic Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Arm Intervention/treatment
Experimental: Group 5-days
5-days targeted antibiotic therapy
Drug: Antibiotic
Targeted antimicrobial therapy

Group 10-days
10-days targeted antibiotic therapy
Drug: Antibiotic
Targeted antimicrobial therapy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: 30-days ]
    In hospital mortality rate

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02899143

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Contact: Vincenzo De Santis

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Ospedale Umberto I Recruiting
Lugo, Ravenna, Italy
Ospedale Santa Maria Delle Croci Recruiting
Ravenna, Italy, 48121
Contact: Maurizio Fusari         
Sponsors and Collaborators
Ospedale Santa Maria delle Croci
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Principal Investigator: Vincenzo De Santis Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna

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Responsible Party: Vincenzo De Santis, Medical Doctor, Ospedale Santa Maria delle Croci Identifier: NCT02899143     History of Changes
Other Study ID Numbers: 1599
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents