Trial Condition(s):
Skin Diseases, Infectious
Safety and efficacy of BAY1192631 in Japanese patients with Methicillin-resistant Staphylococcus aureus (MRSA) infections
Bayer Identifier:
16099
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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).
Inclusion Criteria
No Inclusion Criteria Available
Exclusion 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 - 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Sapporo, Japan, 060-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sendai, Japan, 983-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinagawa, Japan, 141-8625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tachikawa, Japan, 190-0014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meguro-ku, Japan, 152-8902 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Musashimurayama, Japan, 208-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kamakura, Japan, 247-8533 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 455-8530 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 810-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kasuga, Japan, 816-0864 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kumamoto, Japan, 860-0008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koshi, Japan, 861-1196 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nakagami-gun, Japan, 901-2393 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shimajiri, Japan, 901-0493 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ota-ku, Japan, 143-8541 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kofu, Japan, 400-8506 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Numazu, Japan, 410-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagakute, Japan, 480-1195 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gifu, Japan, 500-8513 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tsu, Japan, 514-1101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 534-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shimonoseki, Japan, 750-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitakyushu, Japan, 802-0077 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ota-ku, Japan, 143-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 231-8682 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamamatsu, Japan, 430-0929 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amagasaki, Japan, 660-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yonago, Japan, 683-8605 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kochi, Japan, 781-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyoake, Japan, 470-1192 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miyako-gun, Japan, 800-0344 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 650-0017 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ota-ku, Japan, 145-0065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shizuoka, Japan, 424-8636 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yoshida, Japan, 910-1193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Inashiki-gun, Japan, 300-0395 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tsukuba, Japan, 305-8576 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagasaki, Japan, 852-8501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shizuoka, Japan, 420-8527 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sagamihara, Japan, 252-0375 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iwata, Japan, 438-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 457-8510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sapporo, Japan, 006-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyama, Japan, 930-0194 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Setagaya-ku, Japan, 158-8531 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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.Timeframe: 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.Timeframe: 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 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.Timeframe: 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)Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.Timeframe: 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])Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.Timeframe: 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])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.Timeframe: Baseline and Day 3/4, Day 5/13, EOT, TOC
Additional Information
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