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TerminatedNCT02991131DARTUpdated Oct 2, 2019

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

An observational study in Skin Disease, Infectious, sponsored by Bayer. Terminated at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-02.

Sponsored by Bayer · Observational

Why this study was terminated
Company decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
108
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Skin Disease, Infectious

Keywords

  • Acute bacterial skin infection
  • Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
  • Abscess
  • Cellulitis
  • Erysipelas
  • Wound infection
  • Methicillin resistant Staphylococcus aureus (MRSA)
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 108 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized patients

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

Exclusion Criteria:

  • Patients participating in an investigational program with interventions outside of routine clinical practice.
  • Patients who have been enrolled in this study before.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
108 participants (actual)
Patient registry
No

Groups and cohorts

  • Tedizolid

    Hospitalized ABSSSI patients treated with tedizolid

    Drug: Tedizolid (Sivextro, BAY1192631)

  • Linezolid

    Hospitalized ABSSSI patients treated with linezolid

    Drug: Linezolid

Interventions

  • DrugTedizolid (Sivextro, BAY1192631)

    Antibiotic

  • DrugLinezolid

    Antibiotic

06

What researchers measure

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.

    Time frame: Up to 1 month

Secondary outcomes

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

    Time frame: Up to 1 month

Other outcomes

  1. Number of participants with investigator-assessed clinical response

    Time frame: Up to 1 month

07

Study locations

3 sites
  • Multiple Locations, Mexico
  • Multiple Locations, Russian Federation
  • Multiple Locations, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02991131
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Dec 13, 2016
Start date
Dec 17, 2016
Primary completion
Nov 21, 2018
Completion
Nov 21, 2018
Last update
Oct 2, 2019

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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