NCT02991131

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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
3 countries

3 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

December 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

December 17, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

December 9, 2016

Last Update Submit

September 30, 2019

Conditions

Skin Disease, Infectious

Keywords

Acute bacterial skin infectionAcute Bacterial Skin and Skin Structure Infection (ABSSSI)AbscessCellulitisErysipelasWound infectionMethicillin resistant Staphylococcus aureus (MRSA)

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Number of participants with adverse events or safety-relevant changes in laboratory parameters

    Up to 1 month

Other Outcomes (1)

  • Number of participants with investigator-assessed clinical response

    Up to 1 month

Study Arms (2)

Tedizolid

Hospitalized ABSSSI patients treated with tedizolid

Drug: Tedizolid (Sivextro, BAY1192631)

Linezolid

Hospitalized ABSSSI patients treated with linezolid

Drug: Linezolid

Interventions

Tedizolid (Sivextro, BAY1192631)DRUG

Antibiotic

Tedizolid
LinezolidDRUG

Antibiotic

Linezolid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Multiple Locations, Mexico

Location

Unknown Facility

Multiple Locations, Russia

Location

Unknown Facility

Multiple Locations, Singapore

Location

MeSH Terms

Conditions

Skin Diseases, InfectiousAbscessCellulitisErysipelasWound Infection

Interventions

tedizolidtedizolid phosphateLinezolid

Condition Hierarchy (Ancestors)

InfectionsSkin DiseasesSkin and Connective Tissue DiseasesSuppurationInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSkin Diseases, Bacterial

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 13, 2016

Study Start

December 17, 2016

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

October 2, 2019

Record last verified: 2019-09

Locations

ME(1)RU(1)SG(1)