check_circleStudy Completed

Skin Diseases, Infectious

Bayer Identifier:

16099

ClinicalTrials.gov Identifier:

NCT01967225

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and efficacy of BAY1192631 in Japanese patients with Methicillin-resistant Staphylococcus aureus (MRSA) infections

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
125
Trial Dates
November 2013 - October 2016
Phase
Phase 3
Could I Receive a placebo
No
Products
Sivextro (Tedizolid phosphate, BAY119-2631)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sapporo, 060-0061, Japan
Completed
Sendai, 983-8520, Japan
Completed
Shinagawa, 141-8625, Japan
Completed
Tachikawa, 190-0014, Japan
Completed
Meguro-ku, 152-8902, Japan
Withdrawn
Meguro-ku, 153-8515, Japan
Completed
Musashimurayama, 208-0011, Japan
Completed
Kamakura, 247-8533, Japan
Completed
Nagoya, 455-8530, Japan
Withdrawn
Kyoto, 615-8256, Japan
Withdrawn
Osaka, 540-0006, Japan
Withdrawn
Kishiwada, 596-8522, Japan
Completed
Fukuoka, 810-0001, Japan
Completed
Kasuga, 816-0864, Japan
Completed
Kumamoto, 860-0008, Japan
Completed
Koshi, 861-1196, Japan
Completed
Nakagami-gun, 901-2393, Japan
Completed
Shimajiri, 901-0493, Japan
Withdrawn
Sakura, 285-8741, Japan
Completed
Ota-ku, 143-8541, Japan
Completed
Kofu, 400-8506, Japan
Completed
Numazu, 410-8555, Japan
Completed
Nagakute, 480-1195, Japan
Completed
Gifu, 500-8513, Japan
Withdrawn
Gifu, 501-1194, Japan
Withdrawn
Tsu, 514-8507, Japan
Completed
Tsu, 514-1101, Japan
Completed
Osaka, 534-0021, Japan
Withdrawn
Izumisano, 598-8577, Japan
Withdrawn
Yonago, 683-8504, Japan
Completed
Shimonoseki, 750-8520, Japan
Withdrawn
Kitakyushu, 805-0061, Japan
Completed
Kitakyushu, 802-0077, Japan
Withdrawn
Kurume, 830-8543, Japan
Completed
Ota-ku, 143-0013, Japan
Completed
Yokohama, 231-8682, Japan
Completed
Hamamatsu, 430-0929, Japan
Withdrawn
Kawasaki, 210-0852, Japan
Withdrawn
Morioka, 020-8505, Japan
Completed
Amagasaki, 660-8511, Japan
Completed
Yonago, 683-8605, Japan
Completed
Kochi, 781-8555, Japan
Withdrawn
Kawasaki, 210-0852, Japan
Completed
Shinjuku-ku, 162-8655, Japan
Completed
Toyoake, 470-1192, Japan
Completed
Miyako-gun, 800-0344, Japan
Withdrawn
Fukui, 910-8526, Japan
Withdrawn
Nishinomiya, 663-8501, Japan
Withdrawn
Kure, 737-0193, Japan
Completed
Kobe, 650-0017, Japan
Completed
Ota-ku, 145-0065, Japan
Completed
Shizuoka, 424-8636, Japan
Withdrawn
Chuoku, 104-8560, Japan
Withdrawn
Maebashi, 371-8511, Japan
Completed
Yoshida, 910-1193, Japan
Completed
Inashiki-gun, 300-0395, Japan
Completed
Tsukuba, 305-8576, Japan
Completed
Nagasaki, 852-8501, Japan
Completed
Shizuoka, 420-8527, Japan
Completed
Sagamihara, 252-0375, Japan
Withdrawn
Nagano, 380-8582, Japan
Completed
Iwata, 438-8550, Japan
Withdrawn
Onga-gun, 807-0051, Japan
Completed
Nagoya, 457-8510, Japan
Withdrawn
Nakagami, 903-0215, Japan
Completed
Sapporo, 006-8555, Japan
Completed
Toyama, 930-0194, Japan
Completed
Setagaya-ku, 158-8531, Japan
Withdrawn
Bunkyo-ku, 113-8519, Japan
Withdrawn
Fukuoka, 814-0180, Japan
Withdrawn
Asahikawa, 078-8211, Japan

Primary Outcome

  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Multiple time points up to 7-14 days after the end of treatment
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Baseline and Day 3/4, Day 5/13, EOT, TOC
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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