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

NCT05225558 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: LCB35-0371-21-2-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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.

Conditions

MRSA Bacteremia

Keywords

MRSA; Staphylococcus aureus bacteremia; SAB; bloodstream infection; BSI; Bacteremia

Outcome Measures

Primary Outcomes (2)

• Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_FAS

  * 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'. * Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100

  at Day 14

• Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_PPS

  * 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'. * Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100

  at Day 14

Secondary Outcomes (12)

• Overall Cure Rate by End of Treatment (EOT)_FAS

  Day 7 visit and EOT (up to 6 weeks) visit

• Overall Cure Rate by End of Treatment (EOT)_PPS

  Day 7 visit and EOT (up to 6 weeks) visit

• Mortality From MRSA Bacteremia by EOT_FAS

  During the treatment period (from the first administration to EOT (up to 6 weeks))

• Mortality From MRSA Bacteremia by EOT_PPS

  During the treatment period (from the first administration to EOT (up to 6 weeks))

• Relapse Rate of MRSA bacteremia_FAS

  from the first administration to TOC (4 weeks after EOT)

Other Outcomes (8)

• Vancomycin MIC Level

  at Screening visit (baseline)

• Delpazolid MIC Levels

  Screening (Baseline), Day 14, EOT

• Pharmacokinetics (PK) parameters_AUC,ss

  Plasma samples for pharmacokinetic evaluation were collected once at each timepoint on Day 1 and between Day 3 and end of treatment (EOT), specifically at 30 minutes to 1 hour and 2 to 8 hours after administration of the investigational product.

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Delpazolid; Drug: Vancomycin

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

PLACEBO COMPARATOR

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

Drug: Vancomycin; Drug: Placebo of Delpazolid

Interventions

Delpazolid DRUG

BID, PO

Also known as: LCB01-0371

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

Vancomycin DRUG

IV infusion per 2020 IDSA guideline

Combination therapy - Vancomycin (IV) plus Delpazolid (PO); Monotherapy - Vancomycin (IV) plus Placebo of Delpazolid (PO)

Placebo of Delpazolid DRUG

BID, PO

Also known as: Placebo of LCB01-0371

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LigaChem Biosciences, Inc.: lead

Study Sites (6)

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Sepsis; Bacteremia

Interventions

delpazolid; Vancomycin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Seonghye Cheon
• Organization: LigaChem Biosciences, Inc.

scheon@ligachembio.com

+82)2-6952-0689

Study Officials

• Hongbin Kim

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind with placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 4, 2022
• Study Start: April 26, 2022
• Primary Completion: February 21, 2024
• Study Completion: March 18, 2024
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be provided 1-2 years after and up to 5 years after the publication of the article on the results of the trial.
• Access Criteria: IPD access will be provided for analyses of the related to the aims of research described in the protocol and for individual patient data meta analyses to researches who provide a methodologically sound proposal to lcb\ pv@legochembio.com

Locations

KR (6)