| Primary | 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
| 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. | Posted | | Count of Participants | | Participants | | at Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | 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
| 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 | Posted | | Count of Participants | | Participants | | at Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
|
| Secondary | 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
| 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. | Posted | | Count of Participants | | Participants | | Day 7 visit and EOT (up to 6 weeks) visit | | | | ID | Title | Description |
|---|
| OG000 | 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 |
|
| Secondary | 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
| 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 | Posted | | Count of Participants | | Participants | | Day 7 visit and EOT (up to 6 weeks) visit | | | | ID | Title | Description |
|---|
| OG000 | 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 |
|
| Secondary | 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
| 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. | Posted | | Count of Participants | | Participants | | During the treatment period (from the first administration to EOT (up to 6 weeks)) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | 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
| 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 | Posted | | Count of Participants | | Participants | | During the treatment period (from the first administration to EOT (up to 6 weeks)) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| Secondary | 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
|
- 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.
| Posted | | Count of Participants | | Participants | | from the first administration to TOC (4 weeks after EOT) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| Secondary | 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
|
- 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.
| Posted | | Count of Participants | | Participants | | from the first administration to TOC (4 weeks after EOT) | | | | ID | Title | Description |
|---|
| OG000 | 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 |
|
| Secondary | 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
| 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. | Posted | | Count of Participants | | Participants | | Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Monotherapy - Vancomycin IV Plus Placebo of Delpazolid | |
|
| Secondary | 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
| 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 | Posted | | Count of Participants | | Participants | | Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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 | |
|
| Secondary | 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
| 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. | Posted | | Count of Participants | | Participants | | Day 3, Day 5, Day 7, Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Monotherapy - Vancomycin IV Plus Placebo of Delpazolid | |
|
| Secondary | 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
| 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 | Posted | | Count of Participants | | Participants | | Day 3, Day 5, Day 7, Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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 | |
|
| Secondary | 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. | 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. | Posted | | Median | 95% Confidence Interval | days | | by EOT (up to 6 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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 | |
|
| Secondary | 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. | 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 | Posted | | Median | 95% Confidence Interval | days | | by EOT (up to 6 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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 |
|
| Other Pre-specified | Vancomycin MIC Level | Vancomycin minimum inhibitory concentration (MIC) levels | Participants who received the IP at least once and had samples collected for MIC evaluation among the 40 randomized participants. | Posted | | Mean | Standard Deviation | mcg/ml | | at Screening visit (baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Delpazolid MIC Levels | Delpazolid minimum inhibitory concentration (MIC) level by broth microdilution (BMD) | 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. | Posted | | Mean | Standard Deviation | mcg/ml | | Screening (Baseline), Day 14, EOT | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Pharmacokinetics (PK) parameters_AUC,ss | 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) | 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. | Posted | | Mean | Standard Deviation | ng*h/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Total | 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. | | OG001 | No ESRD | Subjects without End-Stage Renal Disease (ESRD) based on their medical history | | OG002 | ESRD |
|
| Other Pre-specified | Pharmacokinetics (PK) parameters_Cmax,ss | 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) | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Total | 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. | | OG001 | No ESRD | Subjects without End-Stage Renal Disease (ESRD) based on their medical history | | OG002 | ESRD |
|
| Other Pre-specified | Pharmacokinetics (PK) parameters_Cmin,ss | 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) | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Total | 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. | | OG001 | No ESRD | Subjects without End-Stage Renal Disease (ESRD) based on their medical history | | OG002 | ESRD |
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| Other Pre-specified | Pharmacokinetics (PK) parameters_Tmax,ss | 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. (Tmax,ss: Time to reach Cmax at steady state) | 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. | Posted | | Mean | Standard Deviation | h | | 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. | | | | ID | Title | Description |
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| OG000 | Total | 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. | | OG001 | No ESRD | Subjects without End-Stage Renal Disease (ESRD) based on their medical history | | OG002 | ESRD |
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| Other Pre-specified | Pharmacokinetics (PK) parameters_t1/2β | 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. (t1/2β : Terminal elimination half-life) | 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. | Posted | | Mean | Standard Deviation | h | | 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. | | | | ID | Title | Description |
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| OG000 | Total | 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. | | OG001 | No ESRD | Subjects without End-Stage Renal Disease (ESRD) based on their medical history | | OG002 | ESRD |
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| Other Pre-specified | Pharmacokinetics (PK) parameters_MRT,ss | 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. (MRT,ss: Mean residence time at steady state) | 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. | Posted | | Mean | Standard Deviation | h | | 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. | | | | ID | Title | Description |
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| OG000 | Total | 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. | | OG001 | No ESRD | Subjects without End-Stage Renal Disease (ESRD) based on their medical history | | OG002 | ESRD |
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