Short-course Antimicrobial Therapy in Sepsis

NCT ID: NCT02899143

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infection Sepsis Severe Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Group 5-days

5-days targeted antibiotic therapy

Group Type EXPERIMENTAL

Antibiotic

Intervention Type DRUG

Targeted antimicrobial therapy

Group 10-days

10-days targeted antibiotic therapy

Group Type OTHER

Antibiotic

Intervention Type DRUG

Targeted antimicrobial therapy

Interventions

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Antibiotic

Targeted antimicrobial therapy

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Santa Maria delle Croci

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo De Santis

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincenzo De Santis

Role: PRINCIPAL_INVESTIGATOR

Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna

Locations

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Ospedale Umberto I

Lugo, Ravenna, Italy

Site Status RECRUITING

Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce

Cuneo, , Italy

Site Status RECRUITING

ASST Fatebenefratelli Sacco

Milan, , Italy

Site Status RECRUITING

Ospedale Santa Maria Delle Croci

Ravenna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vincenzo De Santis

Role: CONTACT

Facility Contacts

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Domenico Vitale, MD

Role: primary

Alberto Corona

Role: primary

Maurizio Fusari

Role: primary

Other Identifiers

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1599

Identifier Type: -

Identifier Source: org_study_id

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