A Multicenter, Double-blinded, Randomized, Parallel Design, Phase IIa Clinical Trial to Evaluate the Efficacy, Safety and PK of LCB01-0371 With Vancomycin Versus Vancomycin Monotherapy in Patients With MRSA Bacteremia

LCB35-0371-21-2-01

The objectives of this study is to exploratory whether vancomycin + delpazolid is more effective to the standard of treatment (vancomycin)/ for hospitalised adults with MRSA bacteraemia.

2022-04-26

2024-11-01

2024-11-01

Recruiting

Early phase I

100

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 (Subjects who have "re-infection" by investigator's judgement may participant in the study.) * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double-blind with placebo', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-01-25