| Primary | Clinical Success at Day 30 | Clinical success 30 days after collection of the index culture. Clinical success is defined as meeting all of the following criteria at that time point: survival; resolution or near resolution of baseline clinical manifestations, including fever, hypoxia, and signs or symptoms of sepsis; and absence of recurrent infection due to Pseudomonas aeruginosa or persistent infection despite more than 7 days of anti-pseudomonal therapy. | Outcome measures were summarized for 16 unique prospective participants and 48 historical controls, matching the numbers in Participant Flow. The participant who was re-enrolled for a second Pseudomonas aeruginosa infection is counted once for this measure, consistent with the analysis datasets. | Posted | | Count of Participants | | Participants | | 30 days after collection of the index culture | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| Clinical Success | | | Clinical Failure | |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Comparison of the proportion of participants with clinical success at Day 30 between the prospective ceftolozane-tazobactam arm and matched historical controls. | Chi-squared | Two-sided Pearson chi-squared test comparing the prevalence of clinical success between arms. | 0.40 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Survival at Day 30 | Survival status 30 days after initiation of anti-pseudomonal therapy for the index infection, assessed by chart review or phone contact. | Outcome measures were summarized for 16 unique prospective participants and 48 historical controls, matching the numbers in Participant Flow. The participant who was re-enrolled for a second Pseudomonas aeruginosa infection is counted once for this measure, consistent with the analysis datasets. | Posted | | Count of Participants | | Participants | | 30 days after initiation of anti-pseudomonal therapy for the index infection | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Survival at Day 60 | Survival status 60 days after initiation of anti-pseudomonal therapy for the index infection, assessed by chart review or phone contact. | Outcome measures were summarized for 16 unique prospective participants and 48 historical controls, matching the numbers in Participant Flow. The participant who was re-enrolled for a second Pseudomonas aeruginosa infection is counted once for this measure, consistent with the analysis datasets. | Posted | | Count of Participants | | Participants | | 60 days after initiation of anti-pseudomonal therapy for the index infection | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Time to Resolution of Bacteremia | Time (days) from the index positive blood culture for Pseudomonas aeruginosa to bacteremia resolution. Resolution was defined as the date of the first of two consecutive negative blood cultures obtained after the index culture. Participants without follow-up blood cultures were excluded from this analysis. | Analysis limited to participants with Pseudomonas aeruginosa bacteremia who had follow-up blood cultures after the index culture. Participants without follow-up blood cultures were excluded from this outcome. One participant in the prospective cohort was re-enrolled for a second Pseudomonas aeruginosa infection and is counted once for this measure, consistent with the analysis datasets. | Posted | | Median | Inter-Quartile Range | Days | | From index culture collection up to 60 days | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Length of Hospital Stay | Total number of days hospitalized for the admission during which the index Pseudomonas aeruginosa infection is treated, measured beginning on the date of index culture collection and obtained from the Hospitalization Status Assessment. | Outcome measures were summarized for 16 unique prospective participants and 48 historical controls, matching the numbers in Participant Flow. The participant who was re-enrolled for a second Pseudomonas aeruginosa infection is counted once for this measure, consistent with the analysis datasets. | Posted | | Median | Inter-Quartile Range | Days | | From index culture collection through discharge from the hospital admission for the index infection (up to 60 days) | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Emergence of Ceftolozane-tazobactam Resistant Isolates | Occurrence of Pseudomonas aeruginosa isolates that newly demonstrate resistance to ceftolozane-tazobactam on antimicrobial susceptibility testing after initiation of therapy for the index infection. | Assessed only among participants who received ceftolozane-tazobactam. Historical controls were not analyzed (0 participants) because they did not receive ceftolozane-tazobactam. One participant in the prospective cohort was re-enrolled for a second Pseudomonas aeruginosa infection and is counted once for this measure, consistent with the analysis datasets. | Posted | | Count of Participants | | Participants | | From index culture collection up to 60 days | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Time to Appropriate Therapy | Time (in hours) from index culture collection for the index Pseudomonas aeruginosa infection to initiation of an anti-pseudomonal agent deemed appropriate based on antimicrobial susceptibility results. | Outcome measures were summarized for 16 unique prospective participants and 48 historical controls, matching the numbers in Participant Flow. The participant who was re-enrolled for a second Pseudomonas aeruginosa infection is counted once for this measure, consistent with the analysis datasets. | Posted | | Median | Inter-Quartile Range | Hours | | From index culture collection up to 60 days | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Resolution of Baseline Clinical Manifestations | Resolution or near resolution of baseline fever, hypoxia, or signs and symptoms of sepsis related to the index infection at 30 days after index culture collection, as assessed by physical examination findings and clinical documentation. | Outcome measures were summarized for 16 unique prospective participants and 48 historical controls, matching the numbers in Participant Flow. The participant who was re-enrolled for a second Pseudomonas aeruginosa infection is counted once for this measure, consistent with the analysis datasets. | Posted | | Count of Participants | | Participants | | 30 days after collection of the index culture | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Modifications to Initial Antimicrobial Therapy | Number of participants with any modification to the initial study-directed anti-pseudomonal regimen for the index infection, defined as either (1) discontinuation of ceftolozane-tazobactam with switch to another anti-pseudomonal agent or (2) addition of another anti-pseudomonal antibiotic during the treatment course. Outpatient levofloxacin was not considered a modification. | Assessed only among participants who received study-directed ceftolozane-tazobactam. Historical controls were not analyzed (0 participants) because they did not receive ceftolozane-tazobactam. One participant in the prospective cohort was re-enrolled for a second Pseudomonas aeruginosa infection and is counted once for this measure, consistent with the analysis datasets. | Posted | | Count of Participants | | Participants | | From initiation of study ceftolozane-tazobactam therapy through end of study-directed anti-pseudomonal treatment (up to 21 days) | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Emergence of Other Bacteria During Therapy | Identification of new bacterial pathogens identified in blood cultures during study-directed ceftolozane-tazobactam treatment for the index infection. | Assessed only among participants who received ceftolozane-tazobactam. Historical controls were not analyzed (0 participants) because they did not receive ceftolozane-tazobactam. One participant in the prospective cohort was re-enrolled for a second Pseudomonas aeruginosa infection and is counted once for this measure, consistent with the analysis datasets. | Posted | | Count of Participants | | Participants | | From initiation of study ceftolozane-tazobactam therapy through end of ceftolozane-tazobactam treatment (up to 21 days) | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | Number of Days on Ventilator | Total number of days requiring invasive mechanical ventilation during the index admission, measured beginning on the date of index culture collection and abstracted from the medical record. | Outcome measures were summarized for 16 unique prospective participants and 48 historical controls, matching the numbers in Participant Flow. The participant who was re-enrolled for a second Pseudomonas aeruginosa infection is counted once for this measure, consistent with the analysis datasets. | Posted | | Median | Inter-Quartile Range | Days | | From index culture collection through discharge from the hospital admission for the index infection (up to 60 days) | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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| Secondary | ICU Length of Stay | Total number of days spent in an intensive care unit during the index admission, measured beginning on the date of index culture collection and obtained from the Hospitalization Status Assessment. | Outcome measures were summarized for 16 unique prospective participants and 48 historical controls, matching the numbers in Participant Flow. The participant who was re-enrolled for a second Pseudomonas aeruginosa infection is counted once for this measure, consistent with the analysis datasets. | Posted | | Median | Inter-Quartile Range | Days | | From index culture collection through discharge from the hospital admission for the index infection (up to 60 days) | | | | ID | Title | Description |
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| OG000 | Ceftolozane-Tazobactam (Prospective Treatment Arm) | Participants prospectively enrolled in the study received ceftolozane-tazobactam intravenously every 8 hours for approximately 10 to 14 days, with treatment extended up to 21 days if infection persisted or recurred. Outcomes for this arm were assessed according to the protocol's primary and secondary endpoints. | | OG001 | Historical Control (Standard of Care Prior to Study) | This arm consists of historical control patients with documented Pseudomonas aeruginosa bacteremia and/or pneumonia who received standard-of-care antimicrobial therapy prior to initiation of this study. These patients were included retrospectively for comparative analyses of selected primary and secondary endpoints. No study interventions were administered to this arm. |
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