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Short-course Antimicrobial Therapy in Sepsis

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ClinicalTrials.gov Identifier: NCT02899143
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
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

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 : September 2018

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 ]

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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02899143


Contacts
Contact: Vincenzo De Santis vincenzo.desantis@auslromagna.it

Locations
Italy
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
Investigators
Principal Investigator: Vincenzo De Santis Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna

Responsible Party: Vincenzo De Santis, Medical Doctor, Ospedale Santa Maria delle Croci
ClinicalTrials.gov Identifier: NCT02899143     History of Changes
Other Study ID Numbers: 1599
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents