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

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ClinicalTrials.gov Identifier: NCT01967225
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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).

Condition or disease Intervention/treatment Phase
Skin Diseases, Infectious Drug: Tedizolid Phosphate (Sivextro, BAY1192631) Drug: Linezolid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 23, 2013
Actual Primary Completion Date : October 28, 2016
Actual Study Completion Date : October 28, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tedizolid Phosphate (Sivextro, BAY1192631)
Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
Drug: Tedizolid Phosphate (Sivextro, BAY1192631)
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.

Active Comparator: Linezolid
Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
Drug: Linezolid
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.




Primary Outcome Measures :
  1. 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 ]
    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.

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


Secondary Outcome Measures :
  1. Clinical Response at End of Treatment Visit (EOT) [ Time Frame: 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration ]
    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.

  2. Microbiological Response at End of Treatment (EOT) [ Time Frame: 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration ]
    Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.

  3. Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI]) [ Time Frame: Multiple time points up to 7-14 days after the end of treatment ]
    Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.

  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]) [ Time Frame: Baseline and Day 3/4, Day 5/13, EOT, TOC ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967225


Locations
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Japan
Nagakute, Aichi, Japan, 480-1195
Nagoya, Aichi, Japan, 455-8530
Nagoya, Aichi, Japan, 457-8510
Toyoake, Aichi, Japan, 470-1192
Yoshida, Fukui, Japan, 910-1193
Kasuga, Fukuoka, Japan, 816-0864
Kitakyushu, Fukuoka, Japan, 802-0077
Miyako-gun, Fukuoka, Japan, 800-0344
Sapporo, Hokkaido, Japan, 006-8555
Sapporo, Hokkaido, Japan, 060-0061
Amagasaki, Hyogo, Japan, 660-8511
Kobe, Hyogo, Japan, 650-0017
Inashiki-gun, Ibaraki, Japan, 300-0395
Tsukuba, Ibaraki, Japan, 305-8576
Kamakura, Kanagawa, Japan, 247-8533
Sagamihara, Kanagawa, Japan, 252-0375
Yokohama, Kanagawa, Japan, 231-8682
Koshi, Kumamoto, Japan, 861-1196
Tsu, Mie, Japan, 514-1101
Sendai, Miyagi, Japan, 983-8520
Nakagami-gun, Okinawa, Japan, 901-2393
Shimajiri, Okinawa, Japan, 901-0493
Hamamatsu, Shizuoka, Japan, 430-0929
Iwata, Shizuoka, Japan, 438-8550
Numazu, Shizuoka, Japan, 410-8555
Meguro-ku, Tokyo, Japan, 152-8902
Musashimurayama, Tokyo, Japan, 208-0011
Ota-ku, Tokyo, Japan, 143-0013
Ota-ku, Tokyo, Japan, 143-8541
Ota-ku, Tokyo, Japan, 145-0065
Setagaya-ku, Tokyo, Japan, 158-8531
Shinagawa, Tokyo, Japan, 141-8625
Shinjuku-ku, Tokyo, Japan, 162-8655
Tachikawa, Tokyo, Japan, 190-0014
Yonago, Tottori, Japan, 683-8605
Shimonoseki, Yamaguchi, Japan, 750-8520
Kofu, Yamanashi, Japan, 400-8506
Fukuoka, Japan, 810-0001
Gifu, Japan, 500-8513
Kochi, Japan, 781-8555
Kumamoto, Japan, 860-0008
Nagasaki, Japan, 852-8501
Osaka, Japan, 534-0021
Shizuoka, Japan, 420-8527
Shizuoka, Japan, 424-8636
Toyama, Japan, 930-0194
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01967225     History of Changes
Other Study ID Numbers: 16099
First Posted: October 22, 2013    Key Record Dates
Results First Posted: October 4, 2018
Last Update Posted: October 4, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Bayer:
Methicillin Resistant Staphylococcus Aureus,
Skin and soft tissue infection,
Bacteremia,
Tedizolid

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Staphylococcal Infections
Soft Tissue Infections
Skin Diseases, Infectious
Skin Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Linezolid
Methicillin
Tedizolid
Tedizolid phosphate
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action