Phase
Condition
Sepsis And Septicemia
Soft Tissue Infections
Treatment
Vancomycin
Delpazolid
Placebo of Delpazolid
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female ≥19 years of age on the date of written consent
Subject who has confirmed positive MRSA at least one set of blood cultures within 72hours prior to randomization OR, Subject who has confirmed positive MRSA at leastone set of blood culture whthin 96 hours prior to randomization and treated withvancomycin at least 72 hours prior to randomization
Subject who has clinical symptoms or signs of MRSA bacteremia according to thejudgment of the investigator
Subject who voluntarily decides to participate in this clinical trial after beingexplained fully, and agrees in writing to implement the clinical trial compliancematters
Exclusion
Exclusion Criteria:
Subject with polymicrobial bacteremia or infections including Gram-negative strain
Subject undergoing or in need of treatment with antiviral or antifungal drugs
Subject who has received treatment for MRSA bacteremia within 3 months of screening (Subjects who have "re-infection" by investigator's judgement may participant in thestudy.)
Subject who has been administered effective antibiotics against MRSA (Vancomycin,etc.) for more than 96 hours prior to the first investigational productadministration. (However, antibiotics effective for MRSA such as vancomycin areallowed to be administered for less than 72 hours.)
Septic shock patients
Subject who has hypersensitivity to vancomycin or linezolid
Subject who has a history of hypersensitivity to peptide-based antibiotics andaminoglycoside-based antibiotics
Subject who is receiving a MAO inhibitor(MAOI) or has received MAOI within 14 daysof the first investigational drug administration
Subject taking serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptan), meperidine, or buspirone
Subject with severely decreased immunity (Severe neutropenia (ANC <0.5×10^9/L) etc.)
Subject who is expected to die within 2 days due to serious complications of MRSAbacteremia based on the judgment of the investigator
Body Mass Index (BMI) ≥35 kg/m2
Subject who is unable to administer drugs orally
Pregnant or lactating female, female or male with childbearing potential whodisagrees with the use of appropriate contraceptive methods during the study and upto 14 days after the last dose of the investigator product
Subject who has received other clinical trial drugs within 30 days of screening
Subject who is not suitable for participation in this clinical trial according tothe medical findings of investigators
Study Design
Study Description
Connect with a study center
Korea University Ansan Hospital
Ansan,
Korea, Republic ofSite Not Available
Chonnam National University Hospital
Gwangju,
Korea, Republic ofActive - Recruiting
Chosun University Hospital
Gwangju,
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul,
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seoul,
Korea, Republic ofSite Not Available
Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
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