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

Last updated: May 13, 2024
Sponsor: LigaChem Biosciences, Inc.
Overall Status: Terminated

Phase

2

Condition

Sepsis And Septicemia

Soft Tissue Infections

Treatment

Vancomycin

Delpazolid

Placebo of Delpazolid

Clinical Study ID

NCT05225558
LCB35-0371-21-2-01
  • Ages > 19
  • All Genders

Study Summary

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.

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

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Vancomycin
Phase: 2
Study Start date:
April 26, 2022
Estimated Completion Date:
February 16, 2024

Study 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.

Connect with a study center

  • Korea University Ansan Hospital

    Ansan,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Chosun University Hospital

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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