| Primary | Percentage of Participants With Clinical Cure at the Test of Cure (TOC) Visit -Microbiological Intent to Treat (Micro-ITT) Analysis Set | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% confidence interval (CI) was calculated using Jeffrey's method. | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 28 | | | | ID | Title | Description |
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| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. | | OG001 | Best Available Therapy (BAT) | Participants who were hospitalized with a diagnosis of cIAI, NP, HAP, VAP, cUTI or BSI received Best Available Therapy (BAT) based upon site practice and local epidemiology for a maximum of 14 days. Participants with cIAI in the BAT arm received metronidazole if BAT did not provide adequate anaerobic coverage. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00041.7(18.0 to 68.8)
- OG0010.0(NA to NA)95% CI could not be calculated due to insufficient number of participants with events.
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| Secondary | Percentage of Participants With Clinical Cure at the TOC Visit-Microbiologically Evaluable (ME) Analysis Set | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. | ME analysis set: Participants from micro-ITT who received at least 48 hours of study therapy or <48 hours before discontinuation due to an adverse event, no concomitant antibiotics against baseline MBL positive pathogens between first dose of study therapy and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed) and no indeterminate clinical outcomes at TOC. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Participants With Clinical Cure at the End of Treatment (EOT) Visit- Micro-ITT Analysis Set | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Up to 24 hours after the last infusion on Day 14 | | | | ID | Title | Description |
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| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Participants With Clinical Cure at the EOT Visit- ME Analysis Set | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. | ME analysis set: Participants from micro-ITT who received at least 48 hours of study therapy or <48 hours before discontinuation due to an adverse event, no concomitant antibiotics against baseline MBL positive pathogens between first dose of study therapy and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed) and no indeterminate clinical outcomes at TOC. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Up to 24 hours after the last infusion on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-Micro-ITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 colony forming units per milliliter [CFU/mL] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. Participants with a per participant response of Indeterminate were excluded from this analysis. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Up to 24 hours after the last infusion on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at TOC Visit-Micro-ITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 colony forming units per milliliter [CFU/mL] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. Participants with a per participant response of indeterminate were excluded from this analysis. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-ME Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). | ME analysis set: Participants from micro-ITT who received at least 48 hours of study therapy or <48 hours before discontinuation due to an adverse event; no concomitant antibiotics against baseline MBL positive pathogens between first dose of study therapy and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed) and no indeterminate clinical outcomes at TOC. | Posted | | Number | | Percentage of participants | | Up to 24 hours after the last infusion on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at TOC Visit-ME Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). | ME analysis set: Participants from micro-ITT who received at least 48 hours of study therapy or <48 hours before discontinuation due to an adverse event, no concomitant antibiotics against baseline MBL positive pathogens between first dose of study therapy and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed) and no indeterminate clinical outcomes at TOC. | Posted | | Number | | Percentage of participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the EOT Visit-Micro-ITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. All pathogens reported under 'Overall Number of Pathogens Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed (n)'= pathogens evaluable for specified rows. | Posted | | Number | | Percentage of pathogens | | Up to 24 hours after the last infusion on Day 14 | Pathogens | Pathogens | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the TOC Visit-Micro-ITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. All pathogens reported under 'Overall Number of Pathogens Analyzed' contributed data to the table; however, may not have evaluable data for every row. n= pathogens evaluable for specified rows. | Posted | | Number | | Percentage of pathogens | | Day 28 | Pathogens | Pathogens | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the EOT Visit-ME Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). ME analysis set comprised of participants from micro-ITT who received at least 48 hours or <48 hours of study therapy before discontinuation due to AE, no concomitant antibiotics against baseline MBL positive pathogens between 1st dose and TOC (excluding those with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed); no indeterminate clinical outcomes at TOC. | ME analysis set. All pathogens reported under 'Overall Number of Pathogens Analyzed' contributed data to the table; however, may not have evaluable data for every row. n= pathogens evaluable for specified rows. | Posted | | Number | | Percentage of pathogens | | Up to 24 hours after the last infusion on Day 14 | Pathogens | Pathogens | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the TOC Visit-ME Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). ME analysis set comprised of participants from micro-ITT who received at least 48 hours or <48 hours of study therapy before discontinuation due to AE, no concomitant antibiotics against baseline MBL positive pathogens between 1st dose and TOC (excluding those with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed); no indeterminate clinical outcomes at TOC. | ME analysis set. All pathogens reported under 'Overall Number of Pathogens Analyzed' contributed data to the table; however, may not have evaluable data for every row. n= pathogens evaluable for specified rows. | Posted | | Number | | Percentage of pathogens | | Day 28 | pathogens | pathogens | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Percentage of Participants Who Died Within 28 Days From Randomization-ITT Analysis Set | Percentage of participants who died due to any cause on or before 28 days after randomization were reported in this outcome measure. | ITT analysis set included all randomized participants regardless of receipt of study drug. | Posted | | Number | | Percentage of participants | | From randomization up to Day 28 | | | | ID | Title | Description |
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| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. | | OG001 | Best Available Therapy (BAT) | Participants who were hospitalized with a diagnosis of cIAI, NP, HAP, VAP, cUTI or BSI received Best Available Therapy (BAT) based upon site practice and local epidemiology for a maximum of 14 days. Participants with cIAI in the BAT arm received metronidazole if BAT did not provide adequate anaerobic coverage. |
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| Secondary | Percentage of Participants Who Died Within 28 Days From Randomization- Micro ITT Analysis Set | Percentage of participants who died due to any cause on or before 28 days after randomization were reported in this outcome measure. | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. | Posted | | Number | | Percentage of participants | | From randomization up to Day 28 | | | | ID | Title | Description |
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| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. | | OG001 | Best Available Therapy (BAT) | Participants who were hospitalized with a diagnosis of cIAI, NP, HAP, VAP, cUTI or BSI received Best Available Therapy (BAT) based upon site practice and local epidemiology for a maximum of 14 days. Participants with cIAI in the BAT arm received metronidazole if BAT did not provide adequate anaerobic coverage. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events | An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; considered an important medical event. Treatment-emergent adverse event (TEAE) was any AE that started after the study medication start date and time. | Safety analysis set included all participants who received any amount of study treatment. Participants were analyzed according to the treatment they received. | Posted | | Count of Participants | | Participants | | From first dose of study treatment (Day 1) until late follow-up visit (Up to Day 45) | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Number of Participants With Vital Sign Abnormalities | Vital signs included blood pressure and heart rate and were measured in a supine position after at least 10 minutes of rest for the participants. Criteria for vital sign abnormalities included: systolic blood pressure (SBP): value >150 millimeters of mercury (mmHg) and increase from baseline >=30 mmHg and value <90 and decrease from baseline ≥30. Diastolic BP (mm Hg) Value >100 and increase from baseline >= 20 and Value <50 and decrease from baseline >=20. Heart Rate (beats per minute [BPM]): Value <40 or >120. | Safety analysis set included all participants who received any amount of study treatment. Participants were analyzed according to the treatment they received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From first dose of study treatment (Day 1) until TOC (Up to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Number of Participants With Abnormal Physical Examination Findings | Physical examination included assessment of the following: abdomen, cardiovascular, ears, eyes, general appearance, head, lungs, lymph nodes, musculoskeletal, neurological, nose, skin and throat. Number of participants with abnormal physical examination findings for each body system is reported in this outcome measure. | Safety analysis set included all participants who received any amount of study treatment. Participants were analyzed according to the treatment they received. Here, 'Number Analyzed'= participants evaluable for specified rows. | Posted | | Count of Participants | | Participants | | Baseline (last non-missing value observed before start of treatment on Day 1), EOT (Up to 24 hours after the last infusion on Day 14), TOC (Day 28) | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. | | OG001 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Hematology Assessments | Potential clinically significant criteria included: Hematocrit <0.7*lower limit of normal (LLN) and >30% Decrease from Baseline or >1.3*upper limit of normal (ULN) and >30% Increase from Baseline; Hemoglobin: <0.7*LLN and >30% Decrease from Baseline and>1.3*ULN and >30% Increase from Baseline;;Erythrocytes: <0.7*LLN and >30% Decrease from Baseline or >1.3*ULN and >30% Increase from Baseline; Leukocytes: <0.65*LLN and >60% Decrease from Baseline or >1.5*ULN and >100% Increase from Baseline; Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes: >4.0*ULN and>300% Increase from Baseline; Lymphocytes/Leukocytes <0.25*LLN and >75% Decrease from Baseline and >1.5* ULN and >100% Increase from Baseline; Neutrophils/Leukocytes: <0.65*LLN and >75% Decrease from Baseline or >1.6*ULN and >100% Increase from Baseline; Platelets<0.65*LLN and >50% Decrease from Baseline or >1.5*ULN and >100% Increase from Baseline. | Safety analysis set included all participants who received any amount of study treatment. Participants were analyzed according to the treatment they received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed'= participants evaluable for specified rows. | Posted | | Count of Participants | | Participants | | From first dose of study treatment (Day 1) until TOC (Up to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Chemistry Assessments | Criteria for potential clinically significant results were: Aspartate Aminotransferase and Alanine Aminotransferase: >3.0* ULN and >100% increase from baseline (IFB); Bilirubin: >1.5* ULN and >100% IFB; Direct Bilirubin: >2.0* ULN and >150% IFB; Alkaline Phosphatase: 80% decrease from baseline (DFB) and >3.0* ULN and >100% IFB; Urea Nitrogen:100% DFB and >3.0* ULN and >200% IFB; Creatinine >2.0* ULN and >100% IFB; Sodium :10% DFB or >1.1* ULN and >10% IFB; Potassium: 20% DFB or >1.2* ULN and >20% IFB; Chloride: 20% DFB or >1.2*ULN and >20% IFB; Bicarbonate: 40% DFB or >1.3* ULN and >40% IFB; Calcium: 30% DFB or >1.3* ULN and >30% IFB; Albumin: 50% DFB or >1.5* ULN and >50% IFB; Glucose: 40% DFB or >3.0*ULN and >200% IFB. | Safety analysis set included all participants who received any amount of study treatment. Participants were analyzed according to the treatment they received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed'= participants evaluable for specified rows. | Posted | | Count of Participants | | Participants | | From first dose of study treatment (Day 1) until TOC (Up to Day 28) | | | | ID | Title | Description |
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| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | A standard 12-lead ECG was recorded with the participant in a supine position after at least 10 minutes of rest. The following ECG parameters were recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, RR interval. Clinical significance of ECG abnormalities was judged by Investigator. | Safety analysis set included all participants who received any amount of study treatment. Participants were analyzed according to the treatment they received. | Posted | | Count of Participants | | Participants | | From first dose of study treatment (Day 1) until TOC (Up to Day 28) | | | | ID | Title | Description |
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| OG000 | Aztreonam- Avibactam (ATM- AVI) | Participants were administered a loading dose of aztreonam- avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes immediately followed by an extended loading dose of ATM-AVI by infusion over 3 hours, and then started a maintenance dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants with creatinine clearance >50 milliliters per minute (mL/min) and >30 to 50 mL per minute were administered maintenance dose once every 6 hours for maximum of 14 days. Participants with creatinine clearance >15 to 30 mL/min were administered maintenance dose once every 8 hours for maximum of 14 days. Participants with cIAI also received metronidazole (MTZ) 500 milligram (mg) every 8 hours by IV infusion over 60 minutes. | | OG001 | Best Available Therapy (BAT) | |
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