A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia

NCT ID: NCT05225558

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2024-03-18

Brief Summary

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

Detailed Description

The mortality from S aureus bacteremia is higher for MRSA than for methicillin-susceptible S aureus (MSSA), typically at 20% to 25%.

The current standard therapy for MRSA bacteremia is Vancomycin. Vancomycin has many shortcomings, including poor tissue penetration and slow killing time. Vancomycin has reduced efficacy against MRSA and tended to increase the MIC level (called MIC creep). Addition of Delpazolid to Vancomycin could improve the known drawbacks of Vancomycin alone.

Conditions

MRSA Bacteremia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Combination therapy - Vancomycin (IV) plus Delpazolid (PO)

Vancomycin: IV infusion per 2020 IDSA guideline

• 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 were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.
• Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).

Delpazolid: 800 mg, BID, PO

Group Type: EXPERIMENTAL

Delpazolid

Intervention Type: DRUG

BID, PO

Vancomycin

Intervention Type: DRUG

IV infusion per 2020 IDSA guideline

Monotherapy - Vancomycin (IV) plus Placebo of Delpazolid (PO)

Vancomycin: IV infusion per 2020 IDSA guideline

• 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 were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.
• Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).

Placebo of Delpazolid: BID, PO

Group Type: PLACEBO_COMPARATOR

Vancomycin

Intervention Type: DRUG

IV infusion per 2020 IDSA guideline

Placebo of Delpazolid

Intervention Type: DRUG

BID, PO

Interventions

Delpazolid

BID, PO

Intervention Type: DRUG

Vancomycin

IV infusion per 2020 IDSA guideline

Intervention Type: DRUG

Placebo of Delpazolid

BID, PO

Intervention Type: DRUG

Other Intervention Names

LCB01-0371; Placebo of LCB01-0371

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 (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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LigaChem Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongbin Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Chosun University Hospital

Gwangju, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Severance Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LCB35-0371-21-2-01

Identifier Type: -

Identifier Source: org_study_id