MRSA BacteremiaPhase 2NCT05225558
A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia
A Phase 2 study testing Delpazolid and Vancomycin in people with MRSA Bacteremia, run by LigaChem Biosciences, Inc. at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- MRSA Bacteremia
- What is being tested?
- Delpazolid and Vancomycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 26 Apr 2022to 18 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Chosun University Hospital
Gwangju, 61453
Chonnam National University Hospital
Gwangju, 61469
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Korea University Ansan Hospital
Gyeonggi-do, 15355
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
About this study
Official title: 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
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.
Read the 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
- Being tested
- Delpazolid, Vancomycin, Placebo of Delpazolid
- Keywords
- MRSA, Staphylococcus aureus bacteremia, SAB, bloodstream infection, BSI, Bacteremia
- Medical subject headings
- Sepsis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelpazolidDrug
Also called LCB01-0371
BID, PO
VancomycinDrug
IV infusion per 2020 IDSA guideline
Placebo of DelpazolidDrug
Also called Placebo of LCB01-0371
BID, PO
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Vancomycin; Drug: Placebo of Delpazolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at Day 14
Secondary outcomes (12)
Overall Cure Rate by End of Treatment (EOT)_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
Measured: Day 7 visit and EOT (up to 6 weeks) visit
Overall Cure Rate by End of Treatment (EOT)_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
Measured: Day 7 visit and EOT (up to 6 weeks) visit
Mortality From MRSA Bacteremia by EOT_FAS
- Proportion of participants who died due to MRSA bacteremia
- Overall mortality = (number of participants who died/number of participants in each treatment group) x 100
Measured: During the treatment period (from the first administration to EOT (up to 6 weeks))
Mortality From MRSA Bacteremia by EOT_PPS
- Proportion of participants who died due to MRSA bacteremia
- Overall mortality = (number of participants who died/number of participants in each treatment group) x 100
Measured: During the treatment period (from the first administration to EOT (up to 6 weeks))
Relapse Rate of MRSA bacteremia_FAS
- Defined as a positive blood culture to MRSA when previous ones were negative
- Relapse rate of MRSA bacteremia = (number of participants with Relapse of MRSA bacteremia after clearance of MRSA bacteremia until TOC visit/number of participants with clearance of MRSA bacteremia in each treatment group) x 100
Measured: from the first administration to TOC (4 weeks after EOT)
Relapse Rate of MRSA bacteremia_PPS
- Defined as a positive blood culture to MRSA when previous ones were negative
- Relapse rate of MRSA bacteremia = (number of participants with Relapse of MRSA bacteremia after clearance of MRSA bacteremia until TOC visit/number of participants with clearance of MRSA bacteremia in each treatment group) x 100
Measured: from the first administration to TOC (4 weeks after EOT)
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS
- Proportion of participants who confirmed MRSA negative two consecutive set in the blood culture test
- Clearance Rate = (number of subjects who achieved clearance at each visit/number of subjects in each treatment group) x 100
Measured: Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS
- Proportion of participants who confirmed MRSA negative two consecutive set in the blood culture test
- Clearance Rate = (number of subjects who achieved clearance at each visit/number of subjects in each treatment group) x 100
Measured: Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_FAS
- Proportion of participants who have positive results on blood culture tests
- Persistent rate of bacteremia = (number of subjects who showing persistent bacteremia up to each visit /number of subjects in each treatment group up to each visit) x 100
Measured: Day 3, Day 5, Day 7, Day 14
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_PPS
- Proportion of participants who have positive results on blood culture tests
- Persistent rate of bacteremia = (number of subjects who showing persistent bacteremia up to each visit /number of subjects in each treatment group up to each visit) x 100
Measured: Day 3, Day 5, Day 7, Day 14
Time to Clearance of MRSA bacteremia_FAS
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. The period until the clearance of bacteremia is defined as the period (day) from the date of the first blood culture test within 72 hours prior to randomization with MRSA positive (index blood culture) to the date of the blood culture test with the first negative result confirmed.
Measured: by EOT (up to 6 weeks)
Time to Clearance of MRSA bacteremia_PPS
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. The period until the clearance of bacteremia is defined as the period (day) from the date of the first blood culture test within 72 hours prior to randomization with MRSA positive (index blood culture) to the date of the blood culture test with the first negative result confirmed.
Measured: by EOT (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start26 Apr 2022
- Primary completion21 Feb 2024
- Study completion18 Mar 2024
Why it stopped: Early termination; Difficulties in enrolling subjects due to the decrease in patients with MRSA bacteremia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MRSA BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LigaChem Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongbin Kim, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225558
- Sponsor's protocol ID
- LCB35-0371-21-2-01
- Status last verified
- Mar 2025
- First submitted
- 26 Jan 2022
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual patient data, that underlie the results in published article(s) based on data from the trial which including text, tables, figures will be presented to various stakeholders. This reported will be presented to various stakeholder during various forums or meetings. First results will be disclosed to participants, staff and our site Community Advisory Board. Thereafter we would invite several stakeholders from the community or visit their establishments to review study results. Simultaneously, the studying findings report will be sent to the various regulatory authorities, including the National Department of Health (NDoH). With NDoH and its divisions we will establish needs for further engagement and suggestions for policy or programmatic changes.
Publications
Park K-H, Jung J, Shin SU, Jeong SJ, Park DW, Kim D-M, Choi SJ, Moon SM, Park JS, Song K-H, Kim ES, Cho YL, Bae S, Kim HB; Korea INfectious Diseases (KIND) Study Group. Preclinical and clinical evaluation of vancomycin plus delpazolid combination therapy for MRSA bacteremia: a multicenter, double-blinded, randomized, parallel design, phase IIa clinical trial. Microbiol Spectr. 2026 Apr 7;14(4):e0336125. doi: 10.1128/spectrum.03361-25. Epub 2026 Feb 18.
PubMed 41705840
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05225558
- Acronym / sponsor ID
- LCB35-0371-21-2-01
- Conditions
- MRSA Bacteremia
- Keywords
- MRSA, Staphylococcus aureus bacteremia, SAB, bloodstream infection, BSI, Bacteremia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination; Difficulties in enrolling subjects due to the decrease in patients with MRSA bacteremia
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LigaChem Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Combination therapy - Vancomycin (IV) plus Delpazolid (PO) | Experimental | Drug: Delpazolid, Drug: VancomycinVancomycin: 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 |
| Monotherapy - Vancomycin (IV) plus Placebo of Delpazolid (PO) | Placebo comparator | Drug: Vancomycin, Drug: Placebo of DelpazolidVancomycin: 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DelpazolidAlso: LCB01-0371BID, PO | Drug | Combination therapy - Vancomycin (IV) plus Delpazolid (PO) |
| VancomycinIV infusion per 2020 IDSA guideline | Drug | Combination therapy - Vancomycin (IV) plus Delpazolid (PO), Monotherapy - Vancomycin (IV) plus Placebo of Delpazolid (PO) |
| Placebo of DelpazolidAlso: Placebo of LCB01-0371BID, PO | Drug | Monotherapy - Vancomycin (IV) plus Placebo of Delpazolid (PO) |
Primary outcome
Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_FAS
Time frame: at Day 14
* '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
Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_PPS
Time frame: at Day 14
* '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
12 secondary outcomes
Overall Cure Rate by End of Treatment (EOT)_FAS
Time frame: Day 7 visit and EOT (up to 6 weeks) visit
Overall Cure Rate by End of Treatment (EOT)_PPS
Time frame: Day 7 visit and EOT (up to 6 weeks) visit
Mortality From MRSA Bacteremia by EOT_FAS
Time frame: During the treatment period (from the first administration to EOT (up to 6 weeks))
Mortality From MRSA Bacteremia by EOT_PPS
Time frame: During the treatment period (from the first administration to EOT (up to 6 weeks))
Relapse Rate of MRSA bacteremia_FAS
Time frame: from the first administration to TOC (4 weeks after EOT)
Relapse Rate of MRSA bacteremia_PPS
Time frame: from the first administration to TOC (4 weeks after EOT)
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS
Time frame: Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS
Time frame: Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_FAS
Time frame: Day 3, Day 5, Day 7, Day 14
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_PPS
Time frame: Day 3, Day 5, Day 7, Day 14
Time to Clearance of MRSA bacteremia_FAS
Time frame: by EOT (up to 6 weeks)
Time to Clearance of MRSA bacteremia_PPS
Time frame: by EOT (up to 6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41705840Park K-H, Jung J, Shin SU, Jeong SJ, Park DW, Kim D-M, Choi SJ, Moon SM, Park JS, Song K-H, Kim ES, Cho YL, Bae S, Kim HB; Korea INfectious Diseases (KIND) Study Group. Preclinical and clinical evaluation of vancomycin plus delpazolid combination therapy for MRSA bacteremia: a multicenter, double-blinded, randomized, parallel design, phase IIa clinical trial. Microbiol Spectr. 2026 Apr 7;14(4):e0336125. doi: 10.1128/spectrum.03361-25. Epub 2026 Feb 18.
- Individual participant dataSharing planned: Yes. Deidentified individual patient data, that underlie the results in published article(s) based on data from the trial which including text, tables, figures will be presented to various stakeholders. This reported will be presented to various stakeholder during various forums or meetings. First results will be disclosed to participants, staff and our site Community Advisory Board. Thereafter we would invite several stakeholders from the community or visit their establishments to review study results. Simultaneously, the studying findings report will be sent to the various regulatory authorities, including the National Department of Health (NDoH). With NDoH and its divisions we will establish needs for further engagement and suggestions for policy or programmatic changes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongbin Kim principal investigator
Seoul National University Bundang Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delpazolid and Vancomycin in people with MRSA Bacteremia, run by LigaChem Biosciences, Inc. at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_FAS (time frame: at Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.