Sivextro in Acute Bacterial Skin and Skin Structure Infec... | NCT02991131

Studies
Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study

NCT02991131

Sponsor

Bayer

Status

Terminated

Last Update Posted

Oct 2, 2019Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Skin Disease, Infectious

Interventions

Tedizolid (Sivextro, BAY1192631)
Linezolid

Countries

Mexico
Russia
Singapore

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

ID	Type	Description	Link
SX1601	Other Identifier	Company Internal

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company decision

Expanded Access Info

Start Date

Dec 17, 2016Actual

Primary Completion Date

Nov 21, 2018Actual

Completion Date

Nov 21, 2018Actual

First Submitted Date

Dec 9, 2016

First Submission Date that Met QC Criteria

Dec 9, 2016

First Posted Date

Dec 13, 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 30, 2019

Last Update Posted Date

Oct 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

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

This open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intended to provide real life data on the treatment duration, effectiveness and safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real practice setting.

Detailed Description

The primary objective of this study was to assess the treatment duration in the real life in 2 cohorts consisting of patients treated by 200 mg once daily IV/PO tedizolid or treated by 600 mg twice daily IV/PO (intravenous/per oral) linezolid.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tedizolid		Hospitalized ABSSSI patients treated with tedizolid	Drug: Tedizolid (Sivextro, BAY1192631)
Linezolid		Hospitalized ABSSSI patients treated with linezolid	Drug: Linezolid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tedizolid (Sivextro, BAY1192631)	Drug	Antibiotic	Tedizolid
Linezolid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of treatment days	Duration of treatment is defined as the time interval from date of first administration of tedizolid or linezolid to the date of permanent discontinuation of tedizolid or linezolid, respectively. The treatment is according to the recommendations written in the local product information.	Up to 1 month

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events or safety-relevant changes in laboratory parameters		Up to 1 month

Other Outcomes

Measure	Description	Time Frame
Number of participants with investigator-assessed clinical response		Up to 1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult female and male in-patients with clinical diagnosis compatible with ABSSSI (cellulitis/erysipelas, major skin abscess or wound infections) with a clinical suspicion of infection by Gram positive bacteria (with or without laboratory confirmation).
Patients for whom the decision to initiate treatment with tedizolid phosphate or linezolid was made as per physician's routine treatment practice.
Signed informed consent.

Exclusion Criteria:

Patients participating in an investigational program with interventions outside of routine clinical practice.
Patients who have been enrolled in this study before.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hospitalized patients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012874	Skin Diseases, Infectious
D000038	Abscess
D002481	Cellulitis
D004886	Erysipelas
D014946	Wound Infection

Ancestor Terms

ID	Term
D007239	Infections
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D013492	Suppuration

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C546016	tedizolid
C515040	tedizolid phosphate
D000069349	Linezolid

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Multiple Locations			Mexico