Skin Disease, InfectiousDARTNCT02991131
Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study
An observational study of Skin Disease, Infectious, run by Bayer at 3 sites in 3 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Disease, Infectious
- What is being tested?
- Tedizolid (Sivextro, BAY1192631) and Linezolid
- How many people
- 108 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 17 Dec 2016to 21 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients
Who may be able to join
- 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.
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients who have been enrolled in this study before.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy."
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.
- Conditions
- Skin Disease, Infectious
- Being tested
- Tedizolid (Sivextro, BAY1192631), Linezolid
- Keywords
- Acute bacterial skin infection, Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Abscess, Cellulitis, Erysipelas, Wound infection, Methicillin resistant Staphylococcus aureus (MRSA)
- Medical subject headings
- Skin Diseases, Infectious, Abscess, Cellulitis, Erysipelas, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tedizolid (Sivextro, BAY1192631)Drug
Antibiotic
LinezolidDrug
Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Tedizolid | Hospitalized ABSSSI patients treated with tedizolid Receives: Drug: Tedizolid (Sivextro, BAY1192631) | |
| Linezolid | Hospitalized ABSSSI patients treated with linezolid Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 month
Secondary outcomes (1)
Number of participants with adverse events or safety-relevant changes in laboratory parameters
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start17 Dec 2016
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Disease, InfectiousStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991131
- Sponsor's protocol ID
- 18299
- Other IDs
- SX1601
- Acronym
- DART
- Status last verified
- Sep 2019
- First submitted
- 9 Dec 2016
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy."
- ClinicalTrials.gov ID
- NCT02991131
- Acronym / sponsor ID
- DART / 18299
- Conditions
- 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)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 108 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2016 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tedizolid | – | Drug: Tedizolid (Sivextro, BAY1192631)Hospitalized ABSSSI patients treated with tedizolid |
| Linezolid | – | Drug: LinezolidHospitalized ABSSSI patients treated with linezolid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients who have been enrolled in this study before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tedizolid (Sivextro, BAY1192631)Antibiotic | Drug | Tedizolid |
| LinezolidAntibiotic | Drug | Linezolid |
Primary outcome
Number of treatment days
Time frame: Up to 1 month
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.
1 secondary outcome
Number of participants with adverse events or safety-relevant changes in laboratory parameters
Time frame: Up to 1 month
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Disease, Infectious, run by Bayer at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico, Russia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment days (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.