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

NCT01967225 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 16099
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 46

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).

Conditions

Skin Diseases, Infectious

Keywords

Methicillin Resistant Staphylococcus Aureus,; Skin and soft tissue infection,; Bacteremia,; Tedizolid

Outcome Measures

Primary Outcomes (2)

• 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.

  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 at Test of Cure (TOC)

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

  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)

• Clinical Response at End of Treatment Visit (EOT)

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

• Microbiological Response at End of Treatment (EOT)

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

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

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

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

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

Study Arms (2)

Tedizolid Phosphate (Sivextro, BAY1192631)

EXPERIMENTAL

Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))

Drug: Tedizolid Phosphate (Sivextro, BAY1192631)

Linezolid

ACTIVE COMPARATOR

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

Drug: Linezolid

Interventions

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.

Tedizolid Phosphate (Sivextro, BAY1192631)

Linezolid DRUG

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.

Linezolid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (46)

Unknown Facility

Nagakute, Aichi-ken, 480-1195, Japan

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Nagoya, Aichi-ken, 455-8530, Japan

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Nagoya, Aichi-ken, 457-8510, Japan

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Toyoake, Aichi-ken, 470-1192, Japan

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Yoshida, Fukui, 910-1193, Japan

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Kasuga, Fukuoka, 816-0864, Japan

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Kitakyushu, Fukuoka, 802-0077, Japan

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Miyako-gun, Fukuoka, 800-0344, Japan

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Sapporo, Hokkaido, 006-8555, Japan

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Sapporo, Hokkaido, 060-0061, Japan

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Amagasaki, Hyōgo, 660-8511, Japan

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Kobe, Hyōgo, 650-0017, Japan

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Inashiki-gun, Ibaraki, 300-0395, Japan

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Tsukuba, Ibaraki, 305-8576, Japan

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Kamakura, Kanagawa, 247-8533, Japan

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Sagamihara, Kanagawa, 252-0375, Japan

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Yokohama, Kanagawa, 231-8682, Japan

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Kōshi, Kumamoto, 861-1196, Japan

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Tsu, Mie-ken, 514-1101, Japan

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Sendai, Miyagi, 983-8520, Japan

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Nakagami-gun, Okinawa, 901-2393, Japan

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Shimajiri, Okinawa, 901-0493, Japan

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Hamamatsu, Shizuoka, 430-0929, Japan

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Iwata, Shizuoka, 438-8550, Japan

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Numazu, Shizuoka, 410-8555, Japan

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Meguro-ku, Tokyo, 152-8902, Japan

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Musashimurayama, Tokyo, 208-0011, Japan

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Ōta-ku, Tokyo, 143-0013, Japan

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Ōta-ku, Tokyo, 143-8541, Japan

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Ōta-ku, Tokyo, 145-0065, Japan

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Setagaya-ku, Tokyo, 158-8531, Japan

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Shinagawa, Tokyo, 141-8625, Japan

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Shinjuku-ku, Tokyo, 162-8655, Japan

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Tachikawa, Tokyo, 190-0014, Japan

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Yonago, Tottori, 683-8605, Japan

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Shimonoseki, Yamaguchi, 750-8520, Japan

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Kofu, Yamanashi, 400-8506, Japan

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Fukuoka, 810-0001, Japan

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Gifu, 500-8513, Japan

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Kochi, 781-8555, Japan

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Kumamoto, 860-0008, Japan

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Nagasaki, 852-8501, Japan

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Osaka, 534-0021, Japan

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Shizuoka, 420-8527, Japan

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Shizuoka, 424-8636, Japan

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Toyama, 930-0194, Japan

Location

MeSH Terms

Conditions

Skin Diseases, Infectious; Soft Tissue Infections; Bacteremia

Interventions

tedizolid phosphate; Linezolid

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 22, 2013
• Study Start: November 23, 2013
• Primary Completion: October 28, 2016
• Study Completion: October 28, 2016
• Last Updated: October 4, 2018
• Results First Posted: October 4, 2018

Record last verified: 2018-09

Locations

JP (46)