Short-course Antimicrobial Therapy in Sepsis

Sponsor

Ospedale Santa Maria delle Croci (Other)

Overall Status

Recruiting

CT.gov ID

NCT02899143

Collaborator

(none)

320

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 5-days 5-days targeted antibiotic therapy	Drug: Antibiotic Targeted antimicrobial therapy
Other: Group 10-days 10-days targeted antibiotic therapy	Drug: Antibiotic Targeted antimicrobial therapy

Arm

Intervention/Treatment

Experimental: Group 5-days

5-days targeted antibiotic therapy

Drug: Antibiotic

Targeted antimicrobial therapy

Other: Group 10-days

10-days targeted antibiotic therapy

Drug: Antibiotic

Targeted antimicrobial therapy

Outcome Measures

Primary Outcome Measures

sepsis-related organ dysfunction [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

Hospital mortality [30-days]
In hospital mortality rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Umberto I	Lugo	Ravenna	Italy
2	Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce	Cuneo		Italy	12100
3	ASST Fatebenefratelli Sacco	Milano		Italy	20157
4	Ospedale Santa Maria Delle Croci	Ravenna		Italy	48121

Sponsors and Collaborators

Ospedale Santa Maria delle Croci

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vincenzo De Santis, Medical Doctor, Ospedale Santa Maria delle Croci

ClinicalTrials.gov Identifier:

NCT02899143

Other Study ID Numbers:

1599

First Posted:

Sep 14, 2016

Last Update Posted:

Sep 8, 2021

Last Verified:

Sep 1, 2021

Additional relevant MeSH terms:

Sepsis

Toxemia

Anti-Bacterial Agents

Study Results

No Results Posted as of Sep 8, 2021