Short-course Antimicrobial Therapy in Sepsis | NCT02899143

Studies
Short-course Antimicrobial Therapy in Sepsis

NCT02899143

Sponsor

Ospedale Santa Maria delle Croci

Status

Unknown status

Last Update Posted

Sep 8, 2021Actual

Enrollment

320Estimated

Phase

Phase 2

Conditions

Infection
Sepsis
Severe Sepsis
Septic Shock

Interventions

Antibiotic

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Oct 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Sep 8, 2016

First Submission Date that Met QC Criteria

Sep 13, 2016

First Posted Date

Sep 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2021

Last Update Posted Date

Sep 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vincenzo De Santis, Medical Doctor, Ospedale Santa Maria delle CrociPrincipal Investigator

Lead Sponsor

Ospedale Santa Maria delle CrociOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 5-days	Experimental	5-days targeted antibiotic therapy	Drug: Antibiotic
Group 10-days	Other	10-days targeted antibiotic therapy	Drug: Antibiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibiotic	Drug	Targeted antimicrobial therapy	Group 10-days Group 5-days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Hospital mortality	In hospital mortality rate	30-days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vincenzo De Santis	Contact			vincenzo.desantis@auslromagna.it

Overall Officials

Name	Affiliation	Role
Vincenzo De Santis	Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Umberto I	Recruiting	Lugo	Ravenna		Italy
Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000900	Anti-Bacterial Agents

Ancestor Terms

ID	Term
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided