Skin Diseases, Infectious Clinical Trial
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)
Verified date | September 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 125 |
Est. completion date | October 28, 2016 |
Est. primary completion date | October 28, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration | |
Secondary | 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. | 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration | |
Secondary | 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. | Multiple time points up to 7-14 days after the end of treatment | |
Secondary | 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. | Baseline and Day 3/4, Day 5/13, EOT, TOC |
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