Trial Outcomes & Findings for A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia (NCT NCT05225558)

Last Updated: 2025-05-06

Results Overview

* '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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

at Day 14

Results posted on

2025-05-06

Participant Flow

This study was initiated on 26 Apr 2022 (first signed informed consent) with the date of last participant who completed last study visit on 18 Mar 2024. A total of 45 participants were screened. Of these, 40 participants were randomized to 1 of 2 arms. The remaining 5 participants were considered to have been screen failures.

Participant milestones

Participant milestones
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid 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
Overall Study STARTED	20	20
Overall Study Safety Set	18	20
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid 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
Overall Study Withdrawal by Subject	4	3
Overall Study Adverse Event	1	0
Overall Study If the following treatment failure criteria are met during treatment period	1	2
Overall Study When investigators decide that the subject should stop participating in the trial for other reasons	4	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=18 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=20 Participants 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	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=38 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=18 Participants	10 Participants n=20 Participants	15 Participants n=38 Participants
Age, Categorical >=65 years	13 Participants n=18 Participants	10 Participants n=20 Participants	23 Participants n=38 Participants
Age, Continuous	69.3 years STANDARD_DEVIATION 9.68 • n=18 Participants	64.5 years STANDARD_DEVIATION 16.47 • n=20 Participants	66.8 years STANDARD_DEVIATION 13.73 • n=38 Participants
Sex: Female, Male Female	7 Participants n=18 Participants	10 Participants n=20 Participants	17 Participants n=38 Participants
Sex: Female, Male Male	11 Participants n=18 Participants	10 Participants n=20 Participants	21 Participants n=38 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Childbearing potential Yes	0 Participants n=7 Participants • Only female	2 Participants n=10 Participants • Only female	2 Participants n=17 Participants • Only female
Childbearing potential No	7 Participants n=7 Participants • Only female	8 Participants n=10 Participants • Only female	15 Participants n=17 Participants • Only female
Height (cm)	164.15 cm STANDARD_DEVIATION 6.302 • n=18 Participants	161.85 cm STANDARD_DEVIATION 7.582 • n=20 Participants	162.94 cm STANDARD_DEVIATION 7.009 • n=38 Participants
Weight (kg)	64.77 kg STANDARD_DEVIATION 9.536 • n=18 Participants	63.59 kg STANDARD_DEVIATION 13.256 • n=20 Participants	64.14 kg STANDARD_DEVIATION 11.506 • n=38 Participants
BMI (kg/m2)	24.020 kg/m^2 STANDARD_DEVIATION 3.1754 • n=18 Participants	24.229 kg/m^2 STANDARD_DEVIATION 4.6732 • n=20 Participants	24.130 kg/m^2 STANDARD_DEVIATION 3.9823 • n=38 Participants
Primary Lesion Skin and soft tissue infection	1 Participants n=18 Participants	6 Participants n=20 Participants	7 Participants n=38 Participants
Primary Lesion Primary blood stream infection	1 Participants n=18 Participants	3 Participants n=20 Participants	4 Participants n=38 Participants
Primary Lesion Native osteoarticular	2 Participants n=18 Participants	1 Participants n=20 Participants	3 Participants n=38 Participants
Primary Lesion Intravenous line related	2 Participants n=18 Participants	7 Participants n=20 Participants	9 Participants n=38 Participants
Primary Lesion Pleuropulmonary infection	3 Participants n=18 Participants	0 Participants n=20 Participants	3 Participants n=38 Participants
Primary Lesion Device related	0 Participants n=18 Participants	1 Participants n=20 Participants	1 Participants n=38 Participants
Primary Lesion Infective endocarditis	2 Participants n=18 Participants	0 Participants n=20 Participants	2 Participants n=38 Participants
Primary Lesion Unknown	2 Participants n=18 Participants	0 Participants n=20 Participants	2 Participants n=38 Participants
Primary Lesion Other	5 Participants n=18 Participants	3 Participants n=20 Participants	8 Participants n=38 Participants
Primary lesion removable Yes	7 Participants n=18 Participants	11 Participants n=20 Participants	18 Participants n=38 Participants
Primary lesion removable No	11 Participants n=18 Participants	9 Participants n=20 Participants	20 Participants n=38 Participants
Primary lesion removed Yes	4 Participants n=7 Participants • If the primary lesion removable is 'Yes'	6 Participants n=11 Participants • If the primary lesion removable is 'Yes'	10 Participants n=18 Participants • If the primary lesion removable is 'Yes'
Primary lesion removed No	3 Participants n=7 Participants • If the primary lesion removable is 'Yes'	5 Participants n=11 Participants • If the primary lesion removable is 'Yes'	8 Participants n=18 Participants • If the primary lesion removable is 'Yes'
Vancomycin MIC <1.5 mcg/mL	10 Participants n=18 Participants	13 Participants n=20 Participants	23 Participants n=38 Participants
Vancomycin MIC ≥1.5 mcg/mL	8 Participants n=18 Participants	7 Participants n=20 Participants	15 Participants n=38 Participants

PRIMARY outcome

Timeframe: at Day 14

Population: FAS (Full analysis set) : The analysis was conducted on patients who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=19 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_FAS	9 Participants	10 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: at Day 14

Population: PPS(Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance\* was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS. \*(Sum of the number (tab) of actually taken up to the 14th day /14 days (minimum administration period)X4(tab))X100

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=11 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=14 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_PPS	9 Participants	9 Participants	—	—	—	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=19 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Overall Cure Rate by End of Treatment (EOT)_FAS Day 7	7 Participants	6 Participants	—	—	—	—	—
Overall Cure Rate by End of Treatment (EOT)_FAS End of Treatment	12 Participants	14 Participants	—	—	—	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=11 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=14 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Overall Cure Rate by End of Treatment (EOT)_PPS Day 7	6 Participants	5 Participants	—	—	—	—	—
Overall Cure Rate by End of Treatment (EOT)_PPS End of Treatment	10 Participants	12 Participants	—	—	—	—	—

SECONDARY outcome

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

* 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

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=19 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Mortality From MRSA Bacteremia by EOT_FAS Overall death	0 Participants	1 Participants	—	—	—	—	—
Mortality From MRSA Bacteremia by EOT_FAS Death from MRSA bacteremia	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

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

* 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

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=11 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=14 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Mortality From MRSA Bacteremia by EOT_PPS Overall death	0 Participants	1 Participants	—	—	—	—	—
Mortality From MRSA Bacteremia by EOT_PPS Death from MRSA bacteremia	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

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

Population: * Participants in FAS who had MRSA negative two consecutive set in the blood culture test * FAS (Full analysis set) : The analysis was conducted on participants who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.

* 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

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=17 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Relapse Rate of MRSA bacteremia_FAS	2 Participants	1 Participants	—	—	—	—	—

SECONDARY outcome

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

Population: * Participants in PPS who had MRSA negative two consecutive set in the blood culture test * PPS (Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS.

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=11 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=13 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Relapse Rate of MRSA bacteremia_PPS	2 Participants	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)

Population: FAS (Full analysis set) : The analysis was conducted on participants who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.

* 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

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=19 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS Day3	8 Participants	6 Participants	—	—	—	—	—
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS Day5	9 Participants	11 Participants	—	—	—	—	—
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS Day7	7 Participants	6 Participants	—	—	—	—	—
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS Day14	9 Participants	11 Participants	—	—	—	—	—
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS End of Treatment	12 Participants	14 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=11 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=14 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS Day3	5 Participants	5 Participants	—	—	—	—	—
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS Day5	8 Participants	8 Participants	—	—	—	—	—
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS Day7	6 Participants	5 Participants	—	—	—	—	—
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS Day14	9 Participants	10 Participants	—	—	—	—	—
Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS End of Treatment	10 Participants	12 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 3, Day 5, Day 7, Day 14

* 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

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=19 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_FAS Day3	6 Participants	12 Participants	—	—	—	—	—
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_FAS Day5	4 Participants	7 Participants	—	—	—	—	—
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_FAS Day7	1 Participants	3 Participants	—	—	—	—	—
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_FAS Day14	0 Participants	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 3, Day 5, Day 7, Day 14

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=11 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=14 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_PPS Day3	5 Participants	9 Participants	—	—	—	—	—
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_PPS Day5	3 Participants	6 Participants	—	—	—	—	—
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_PPS Day7	0 Participants	3 Participants	—	—	—	—	—
Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_PPS Day14	0 Participants	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: by EOT (up to 6 weeks)

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.

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=19 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Time to Clearance of MRSA bacteremia_FAS	7.00 days Interval 3.0 to 14.0	8.00 days Interval 4.0 to 18.0	—	—	—	—	—

SECONDARY outcome

Timeframe: by EOT (up to 6 weeks)

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=11 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=14 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Time to Clearance of MRSA bacteremia_PPS	4.00 days Interval 3.0 to 14.0	7.00 days Interval 4.0 to 18.0	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: at Screening visit (baseline)

Population: Participants who received the IP at least once and had samples collected for MIC evaluation among the 40 randomized participants.

Vancomycin minimum inhibitory concentration (MIC) levels

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=16 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=16 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Vancomycin MIC Level	0.78 mcg/ml Standard Deviation 0.256	0.75 mcg/ml Standard Deviation 0.258	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening (Baseline), Day 14, EOT

Population: Participants in the Safety Set who were evaluated for Delpazolid MIC at baseline, Day 14, and EOT. Of the subjects in the SS (combination: 18 subjects, monotheray: 20 subjects), Delpazolid MIC was evaluated in 18 and 17 subjects from the combination and monotherapy groups at screening, 1 and 2 at Day 14, and 1 and 0 at EOT, respectively.

Delpazolid minimum inhibitory concentration (MIC) level by broth microdilution (BMD)

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=18 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=20 Participants 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	ESRD Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Delpazolid MIC Levels Baseline	1.1 mcg/ml Standard Deviation 0.34	1.1 mcg/ml Standard Deviation 0.42	—	—	—	—	—
Delpazolid MIC Levels Day14	1.0 mcg/ml Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	1.0 mcg/ml Standard Deviation 0.00	—	—	—	—	—
Delpazolid MIC Levels End of Treatment	1.0 mcg/ml Standard Deviation NA Standard Deviation not calculable because data were only collected for 1 participant	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Population: Out of the total 40 enrolled patients, the blood concentrations of LCB01-0371 from the 15 patients in the treatment group who received LCB01-0371 (excluding the 19 control subjects who received placebo) were included in the population PK model analysis.

Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model. (AUC,ss: Area under the concentration-time curve at steady state)

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=8 Participants 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	ESRD n=7 Participants Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD n=9 Participants Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD n=6 Participants Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC n=10 Participants Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC n=5 Participants Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Pharmacokinetics (PK) parameters_AUC,ss	90,855.222 ng*h/mL Standard Deviation 88,895.538	83,671.053 ng*h/mL Standard Deviation 75,411.511	99,065.701 ng*h/mL Standard Deviation 107,966.645	112,462.317 ng*h/mL Standard Deviation 111,518.903	58,444.580 ng*h/mL Standard Deviation 11,292.560	59,842.551 ng*h/mL Standard Deviation 26,423.362	152,880.564 ng*h/mL Standard Deviation 137,383.144

OTHER_PRE_SPECIFIED outcome

Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model. (Cmax,ss: Maximum concentration of drug at steady state)

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=8 Participants 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	ESRD n=7 Participants Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD n=9 Participants Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD n=6 Participants Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC n=10 Participants Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC n=5 Participants Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Pharmacokinetics (PK) parameters_Cmax,ss	8,595.050 ng/mL Standard Deviation 7,229.136	8,610.266 ng/mL Standard Deviation 5,715.031	8,577.661 ng/mL Standard Deviation 9,156.152	10,903.652 ng/mL Standard Deviation 8,712.950	5,132.147 ng/mL Standard Deviation 938.601	6,216.075 ng/mL Standard Deviation 1,624.925	13,353.002 ng/mL Standard Deviation 11,598.454

OTHER_PRE_SPECIFIED outcome

Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model. (Cmin,ss: Minimum concentration of drug at steady state)

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=8 Participants 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	ESRD n=7 Participants Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD n=9 Participants Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD n=6 Participants Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC n=10 Participants Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC n=5 Participants Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Pharmacokinetics (PK) parameters_Cmin,ss	6,586.689 ng/mL Standard Deviation 7,255.844	5,541.150 ng/mL Standard Deviation 6,209.527	7,781.590 ng/mL Standard Deviation 8,644.985	7,955.430 ng/mL Standard Deviation 9,284.244	4,533.576 ng/mL Standard Deviation 1,032.638	3,992.895 ng/mL Standard Deviation 2,331.779	11,774.277 ng/mL Standard Deviation 11,026.039

OTHER_PRE_SPECIFIED outcome

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=8 Participants 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	ESRD n=7 Participants Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD n=9 Participants Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD n=6 Participants Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC n=10 Participants Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC n=5 Participants Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Pharmacokinetics (PK) parameters_Tmax,ss	3.562 h Standard Deviation 1.322	3.083 h Standard Deviation 1.515	4.110 h Standard Deviation 0.861	3.286 h Standard Deviation 1.542	3.978 h Standard Deviation 0.861	3.291 h Standard Deviation 1.429	4.105 h Standard Deviation 0.984

OTHER_PRE_SPECIFIED outcome

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=8 Participants 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	ESRD n=7 Participants Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD n=9 Participants Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD n=6 Participants Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC n=10 Participants Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC n=5 Participants Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Pharmacokinetics (PK) parameters_t1/2β	9,292.011 h Standard Deviation 28,745.858	1,689.649 h Standard Deviation 4,369.248	17,980.425 h Standard Deviation 41,721.541	13,973.252 h Standard Deviation 37,076.761	2,270.149 h Standard Deviation 3,949.333	425.392 h Standard Deviation 572.107	27,025.249 h Standard Deviation 47,976.785

OTHER_PRE_SPECIFIED outcome

Outcome measures

Outcome measures
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=15 Participants 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=8 Participants 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	ESRD n=7 Participants Subjects with End-Stage Renal Disease (ESRD) based on their medical history	Not Undergoing HD n=9 Participants Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history	Undergoing HD n=6 Participants Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history	No HI/LC n=10 Participants Subjects not included in either LC\* or HI\\ \LC: Liver cirrhosis \\*HI: Hepatic impairment status according to the NCI-ODWG criteria	HI/LC n=5 Participants Subjects included in either LC\* or HI\\, i.e., the combination of LC and HI \HI: Hepatic impairment status according to the NCI-ODWG criteria \\*LC: Liver cirrhosis
Pharmacokinetics (PK) parameters_MRT,ss	6,843.719 h Standard Deviation 20,060.037	1,159.389 h Standard Deviation 3,024.815	13,340.095 h Standard Deviation 28,912.833	9,730.567 h Standard Deviation 25,868.738	2,513.446 h Standard Deviation 4,304.084	436.814 h Standard Deviation 654.947	19,657.528 h Standard Deviation 33,160.057

Adverse Events

Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Monotherapy - Vancomycin IV Plus Placebo of Delpazolid

Serious events: 1 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID n=18 participants at risk 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: BID, PO	Monotherapy - Vancomycin IV Plus Placebo of Delpazolid n=20 participants at risk 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
Renal and urinary disorders end stage renal disease	0.00% 0/18 • From IP administration to TOC (Test of Cure, 4 weeks after EOT), approximately 10 weeks EOT (End of treatment): up to 6 weeks All clinically significant medical conditions or abnormalities observed from the administration of the IP until TOC were collected as AEs. If an AE identified before the administration of the IP worsened in severity after the IP administration, it was collected as a new AE.	5.0% 1/20 • Number of events 1 • From IP administration to TOC (Test of Cure, 4 weeks after EOT), approximately 10 weeks EOT (End of treatment): up to 6 weeks All clinically significant medical conditions or abnormalities observed from the administration of the IP until TOC were collected as AEs. If an AE identified before the administration of the IP worsened in severity after the IP administration, it was collected as a new AE.

Other adverse events

Additional Information

Seonghye Cheon

LigaChem Biosciences, Inc.

Phone: +82)2-6952-0689

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place