| Primary | Clinical Outcome in the MITT Analysis Set at EOIV. | The primary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Posted | | Count of Participants | | Participants | | Within 72 hours after administration of the last dose of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Participants may receive other addtional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| Favorable clinical resposne | | | Clinical failure | |
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| Secondary | Clinical Outcome in the mMITT Analysis Set at EOIV. | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies | Posted | | Count of Participants | | Participants | | Within 72 hours after administration of the last dose of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Patients may receive other addtional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the CE Analysis Set at EOIV. | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in CE (Clinically Evaluable) Analysis Set - A subset of the MITT Analysis Set including patients with the following conditions: Received >=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received >=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC | Posted | | Count of Participants | | Participants | | Within 72 hours after administration of the last dose of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Patients may receive other addtional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the MITT Analysis Set at TOC. | The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. | Pateints in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Posted | | Count of Participants | | Participants | | 21 to 28 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Patients may receive other addtional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the MITT Analysis Set at LFU. | The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. | Pateints in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Posted | | Count of Participants | | Participants | | 35 to 42 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the mMITT Analysis Set at TOC. | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Posted | | Count of Participants | | Participants | | 21 to 28 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Patients may receive other addtional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the mMITT Analysis Set at LFU. | The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Posted | | Count of Participants | | Participants | | Pateints in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Patients may receive other addtional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the CE Analysis Set at TOC. | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. | Patients in CE (Clinically Evaluable) Analysis Set - A subset of the MITT Analysis Set including patients with the following conditions: Received >=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received >=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC | Posted | | Count of Participants | | Participants | | 21 to 28 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the CE Analysis Set at LFU. | The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. | Patients in CE (Clinically Evaluable) Analysis Set - A subset of the MITT Analysis Set including patients with the following conditions: Received >=48 hrs of IV study drug to be considered an evaluable clinical failure, unless deemed a clinical failure based on a treatment-limiting AE Received >=48 hrs of IV gram negative coverage to be considered an evaluable clinical cure Had clinical outcome assessment at TOC (other than indeterminate) or assessed as clinical failure at EOIV or TOC | Posted | | Count of Participants | | Participants | | 35 to 42 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may continue on the study drug for up to 14 days. Patients may receive other addtional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the ME Analysis Set at EOIV. | The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate. | Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets. | Posted | | Count of Participants | | Participants | | Within 72 hours after administration of the last dose of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other addtional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the ME Analysis Set at TOC. | The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. | Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets. | Posted | | Count of Participants | | Participants | | 21 to 28 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Clinical Outcome in the ME Analysis Set at LFU. | The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Clinical cure, Clinical failure, and Indeterminate. | Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets. | Posted | | Count of Participants | | Participants | | 35 to 42 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Microbiological Outcome in the mMITT Analysis Set at EOIV. | The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Posted | | Count of Participants | | Participants | | Within 72 hours after administration of the last dose of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Microbiological Outcome in the mMITT Analysis Set at TOC. | The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Posted | | Count of Participants | | Participants | | 21 to 28 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
|
| Secondary | Microbiological Outcome in the mMITT Analysis Set at LFU. | The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Posted | | Count of Participants | | Participants | | 35 to 42 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Microbiological Outcome in the ME Analysis Set at EOIV. | The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. | Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets. | Posted | | Count of Participants | | Participants | | Within 72 hours after administration of the last dose of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Microbiological Outcome in the ME Analysis Set at TOC. | The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. | Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets. | Posted | | Count of Participants | | Participants | | 21 to 28 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy.. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Microbiological Outcome in the ME Analysis Set at LFU. | The secondary efficacy outcome is favorable microbiological response of the participants in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The microbiological response outcome has five categories: Persistence, eradication, presumed eradication, presumed persistence, and Indeterminate. | Patients in ME (Microbiologically Evaluable) Analysis Set The ME Analysis Set will include patients who meet the criteria for both the CE and mMITT analysis sets. | Posted | | Count of Participants | | Participants | | 35 to 42 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Infection-related Mortality in the MITT Analysis Set at TOC. | The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). | Participants in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Posted | | Count of Participants | | Participants | | 21 to 28 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Infection-related Mortality in the MITT Analysis Set at LFU. | The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). | Patients in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Posted | | Count of Participants | | Participants | | 35 to 42 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
|---|
| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | Infection-related Mortality in the mMITT Analysis Set at TOC. | The secondary efficacy outcome is Infection-related mortality of the participants in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Posted | | Count of Participants | | Participants | | 21 to 28 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
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| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Participants receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Participants may receive other additional therapy. |
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| Secondary | Infection-related Mortality in the mMITT Analysis Set at LFU. | The secondary efficacy outcome is Infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). | Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Posted | | Count of Participants | | Participants | | 35 to 42 days after the start of inpatient IV study drug. | | | | ID | Title | Description |
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| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | 30-Day All-cause Mortality in the MITT Analysis Set. | The secondary efficacy outcome is 30-day all-cause mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set. | Patients in MITT (Modified Intent-To-Treat) Analysis Set The MITT Analysis Set will be a subset of the ITT Analysis Set and will include all randomized patients who received any amount of inpatient IV study drug and meet minimal disease criteria (Inclusion Criterion 3). Patients will be analyzed according to randomized treatment group, regardless of treatment received. | Posted | | Count of Participants | | Participants | | 30 days after the last dose of inpatient IV study drug. | | | | ID | Title | Description |
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| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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| Secondary | 30-Day All-cause Mortality in the mMITT Analysis Set. | The secondary efficacy outcome is 30-day all-cause mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set. | Patients in MITT (Modified Intent-To-Treat) Analysis Set The mMITT Analysis Set will be a subset of the MITT Analysis Set and will include those patients for whom at least 1 qualifying bacterial pathogen was isolated from an appropriate microbiological specimen at baseline, irrespective of susceptibility to study therapies. | Posted | | Count of Participants | | Participants | | 30 days after the last dose of inpatient IV study drug. | | | | ID | Title | Description |
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| OG000 | Imipenem-Relebactam Arm | Patients receive imipenem/cilastatin/relebactam IV over 30-60 minutes once every 6 hours (q6h) for 2 days for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or Patients may continue on the study drug for up to 14 days. Patients may receive other additional therapy. | | OG001 | Standard of Care (SOC) Arm | Patients receive cefepime IV q8h for a minimum of 6 doses, or meropenem IV q8h for a minimum of 6 doses, or piperacillin/tazobactam IV q6h for a minimum of 8 doses. May also receive gram-positive therapy consisting of vancomycin IV q 12h or linezolid IV or orally (PO) q12h. Daptomycion could be given if no pneumonia. Patients may receive other additional therapy. |
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