NCT02899143

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

5.1 years

First QC Date

September 8, 2016

Last Update Submit

September 7, 2021

Conditions

InfectionSepsisSevere SepsisSeptic Shock

Outcome Measures

Primary Outcomes (1)

  • 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.

    14-days

Secondary Outcomes (1)

  • Hospital mortality

    30-days

Study Arms (2)

Group 5-days

EXPERIMENTAL

5-days targeted antibiotic therapy

Drug: Antibiotic

Group 10-days

OTHER

10-days targeted antibiotic therapy

Drug: Antibiotic

Interventions

AntibioticDRUG

Targeted antimicrobial therapy

Group 10-daysGroup 5-days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who received antibiotics for presumed infection

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ospedale Umberto I

Lugo, Ravenna, Italy

RECRUITING

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

Cuneo, 12100, Italy

RECRUITING

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

RECRUITING

Ospedale Santa Maria Delle Croci

Ravenna, 48121, Italy

RECRUITING

MeSH Terms

Conditions

InfectionsSepsisShock, Septic

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Vincenzo De Santis

    Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo De Santis

CONTACT

vincenzo.desantis@auslromagna.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 14, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

IT(4)