A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia
MRSA Bacteremia
About this trial
This is an interventional treatment trial for MRSA Bacteremia focused on measuring MRSA, Staphylococcus aureus bacteremia, SAB, bloodstream infection, BSI, Bacteremia
Eligibility Criteria
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 72 hours prior to randomization OR, Subject who has confirmed positive MRSA at least one set of blood culture whthin 96 hours prior to randomization and treated with vancomycin at least 72 hours prior to randomization
- Subject who has clinical symptoms or signs of MRSA bacteremia according to the judgment of the investigator
- Subject who voluntarily decides to participate in this clinical trial after being explained fully, and agrees in writing to implement the clinical trial compliance matters
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
- Subject who has been administered effective antibiotics against MRSA (Vancomycin, etc.) for more than 96 hours prior to the first investigational product administration. (However, antibiotics effective for MRSA such as vancomycin are allowed 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 and aminoglycoside-based antibiotics
- Subject who is receiving a MAO inhibitor(MAOI) or has received MAOI within 14 days of 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 MRSA bacteremia 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 who disagrees with the use of appropriate contraceptive methods during the study and up to 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 to the medical findings of investigators
Sites / Locations
- Korea University Ansan Hospital
- Chonnam National University HospitalRecruiting
- Chosun University Hospital
- Asan Medical CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Combination therapy - Vancomycin IV plus Delpazolid 800 mg, PO, BID
Monotherapy - Vancomycin IV plus Placebo of Delpazolid
Intravenous vancomycin dosed as per 2020 IDSA guideline Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion are recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L. Depending on the investigator's judgment, it is allowed to change to daptomycin after at least one week of administration of vancomycin, and also it is allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of vancomycin (including daptomycin).
Intravenous vancomycin dosed as per 2020 IDSA guideline Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion are recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L. Depending on the investigator's judgment, it is allowed to change to daptomycin after at least one week of administration of vancomycin, and also it is allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of vancomycin (including daptomycin).