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Short-course Antimicrobial Therapy in Sepsis

O

Ospedale Santa Maria delle Croci

Status and phase

Unknown
Phase 2

Conditions

Infection
Severe Sepsis
Septic Shock
Sepsis

Treatments

Drug: Antibiotic

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

320 estimated patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

320 participants in 2 patient groups

Group 5-days
Experimental group
Description:
5-days targeted antibiotic therapy
Treatment:
Drug: Antibiotic
Group 10-days
Other group
Description:
10-days targeted antibiotic therapy
Treatment:
Drug: Antibiotic

Trial contacts and locations

4

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Central trial contact

Vincenzo De Santis

Data sourced from clinicaltrials.gov

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