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Skin Diseases, InfectiousPhase 3NCT01967225

Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections

A Phase 3 study testing Tedizolid Phosphate (Sivextro, BAY1192631) and Linezolid in people with Skin Diseases, Infectious, run by Bayer at 46 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Diseases, Infectious
What is being tested?
Tedizolid Phosphate (Sivextro, BAY1192631) and Linezolid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
46 sitesJapan
Study dates
23 Nov 2013to 28 Oct 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Suspected or confirmed Methicillin-resistant Staphylococcus aureus (MRSA) infection
  • Japanese Male and female patients aged 18 years or above
  • Diagnosis of Skin and soft tissue infection with MRSA either suspected or confirmed as the major cause of infection, with/without SSTI (skin and soft tissue infection)-derived MRSA bacteremia suspected

Who cannot join

  • Having received any systemic antibacterial potentially effective against MRSA for >/=24 hours within 3 days prior to the first infusion of a study drug, or having received/expected to receive the medication within 24 hours prior to the first infusion, unless antibacterial therapy for >/=72 hours proves to be ineffective on or lack appropriate potency (resistant) to MRSA.
  • Moribund clinical condition such as death likely within the first 3 days of a study drug treatment
  • History of significant allergy or intolerance to linezolid or BAY1192631
  • Known or suspected human immunodeficiency virus (HIV) infection with a CD4+ T-cell count < 200/μL
  • Chronic treatment with immunosuppressive drugs
  • Active tuberculosis or non-tuberculous mycobacteriosis which need medical treatments
  • Current or anticipated neutropenia with neutrophil count < 1,000/ mm^3
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >/= 8 times the upper limit of reference range OR moderate to severe hepatic disease with Child Pugh score >/=10.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Japan46 sites

  • Study site

    Amagasaki, Hyōgo, 660-8511

  • Study site

    Fukuoka, 810-0001

  • Study site

    Gifu, 500-8513

  • Study site

    Hamamatsu, Shizuoka, 430-0929

  • Study site

    Inashiki-gun, Ibaraki, 300-0395

  • Study site

    Iwata, Shizuoka, 438-8550

  • Study site

    Kamakura, Kanagawa, 247-8533

  • Study site

    Kasuga, Fukuoka, 816-0864

  • Study site

    Kitakyushu, Fukuoka, 802-0077

  • Study site

    Kobe, Hyōgo, 650-0017

  • Study site

    Kochi, 781-8555

  • Study site

    Kofu, Yamanashi, 400-8506

  • Study site

    Kōshi, Kumamoto, 861-1196

  • Study site

    Kumamoto, 860-0008

  • Study site

    Meguro-ku, Tokyo, 152-8902

  • Study site

    Miyako-gun, Fukuoka, 800-0344

  • Study site

    Musashimurayama, Tokyo, 208-0011

  • Study site

    Nagakute, Aichi-ken, 480-1195

  • Study site

    Nagasaki, 852-8501

  • Study site

    Nagoya, Aichi-ken, 455-8530

  • Study site

    Nagoya, Aichi-ken, 457-8510

  • Study site

    Nakagami-gun, Okinawa, 901-2393

  • Study site

    Numazu, Shizuoka, 410-8555

  • Study site

    Osaka, 534-0021

  • Study site

    Ōta-ku, Tokyo, 143-0013

  • Study site

    Ōta-ku, Tokyo, 143-8541

  • Study site

    Ōta-ku, Tokyo, 145-0065

  • Study site

    Sagamihara, Kanagawa, 252-0375

  • Study site

    Sapporo, Hokkaido, 006-8555

  • Study site

    Sapporo, Hokkaido, 060-0061

  • Study site

    Sendai, Miyagi, 983-8520

  • Study site

    Setagaya-ku, Tokyo, 158-8531

  • Study site

    Shimajiri, Okinawa, 901-0493

  • Study site

    Shimonoseki, Yamaguchi, 750-8520

  • Study site

    Shinagawa, Tokyo, 141-8625

  • Study site

    Shinjuku-ku, Tokyo, 162-8655

  • Study site

    Shizuoka, 420-8527

  • Study site

    Shizuoka, 424-8636

  • Study site

    Tachikawa, Tokyo, 190-0014

  • Study site

    Toyama, 930-0194

  • Study site

    Toyoake, Aichi-ken, 470-1192

  • Study site

    Tsu, Mie-ken, 514-1101

  • Study site

    Tsukuba, Ibaraki, 305-8576

  • Study site

    Yokohama, Kanagawa, 231-8682

  • Study site

    Yonago, Tottori, 683-8605

  • Study site

    Yoshida, Fukui, 910-1193

Other trials in Japan

About this study

Official title: A Prospective, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of BAY 1192631 in Japanese Patients With MRSA Infections (Skin and Soft Tissue Infection [SSTI] and SSTI-related Bacteremia)

The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia).

Being tested
Tedizolid Phosphate (Sivextro, BAY1192631), Linezolid
Keywords
Methicillin Resistant Staphylococcus Aureus,, Skin and soft tissue infection,, Bacteremia,, Tedizolid
Medical subject headings
Skin Diseases, Infectious, Soft Tissue Infections, Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tedizolid Phosphate (Sivextro, BAY1192631)Drug

    BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.

  • LinezolidDrug

    Linezolid solution or tablet 600 mg, twice daily, every 12 ±3 hours, Intravenous (IV) or By mouth (PO) 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.

Study groups in NCT01967225
Study groupRoleWhat they receive
Tedizolid Phosphate (Sivextro, BAY1192631)ExperimentalParticipants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
Receives: Drug: Tedizolid Phosphate (Sivextro, BAY1192631)
LinezolidActive comparatorParticipants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
Receives: Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Response at Test of Cure (TOC)

    Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.

    Measured: 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia

  2. Microbiological Response at Test of Cure (TOC)

    Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.

    Measured: 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia

Secondary outcomes (4)

  1. Clinical Response at End of Treatment Visit (EOT)

    Clinical response was evaluated by the masked investigator as effective, ineffective and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.

    Measured: 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration

  2. Microbiological Response at End of Treatment (EOT)

    Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.

    Measured: 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration

  3. Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])

    Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.

    Measured: Multiple time points up to 7-14 days after the end of treatment

  4. Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])

    Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest. Reduction ratio (%) = 100 * (the post baseline value - baseline value) / baseline value. Negative values represent reduction of lesion size compared to baseline.

    Measured: Baseline and Day 3/4, Day 5/13, EOT, TOC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2013 (estimated)
  2. Study start23 Nov 2013
  3. Primary completion28 Oct 2016
  4. Study completion28 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01967225
Sponsor's protocol ID
16099
Status last verified
Sep 2018
First submitted
18 Oct 2013
Last updated
4 Oct 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tedizolid Phosphate (Sivextro, BAY1192631) and Linezolid in people with Skin Diseases, Infectious, run by Bayer at 46 sites in Japan.

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 8 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: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Japan. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Response at Test of Cure (TOC) (time frame: 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01967225.

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 4 Oct 2018.

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