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| ID | Type | Description | Link |
|---|---|---|---|
| CXA-PEDS-13-08 | Other Identifier | Cubist Pharmaceuticals LLC Protocol Number | |
| 2014-003485-24 | EudraCT Number | ||
| MK-7625A-010 | Other Identifier | Merck Protocol Number |
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The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants. In each of the 6 age cohorts, an interim analysis of pharmacokinetics (PK) and safety data was conducted after approximately 3 participants had received the initially proposed dose. The interim analysis was to determine whether the initial dose was appropriate based on pre-defined criteria. If data from the interim analysis demonstrated that the initially proposed dose met the above criteria, enrollment was to continue with the same dose administered to approximately 3 additional participants of the same age range. However, if the interim analysis demonstrated that a new optimized dose was required, the new dose was to be administered to approximately 3 additional participants of the same age range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: ≥12 to <18 years TOL/TAZ 1000/500 mg FDC | Experimental | Participants ≥12 to <18 years of age received a single dose of ceftolozane/tazobactam (TOL/TAZ) 1000/500 mg FDC as a 60-minute infusion on Day 1. |
|
| Cohort 2: ≥7 to <12 years TOL/TAZ 18/9 mg/kg | Experimental | Participants ≥7 to <12 years of age received a single dose of TOL/TAZ 18/9 mg/kg as a 60-minute infusion on Day 1. |
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| Cohort 3: ≥2 to <7 years TOL/TAZ 18/9 or 30/15 mg/kg | Experimental | Participants ≥2 to <7 years of age received a single dose of TOL/TAZ 18/9 mg/kg as a 60-minute infusion on Day 1. Participants in this cohort enrolled after interim analysis for Cohort 3 received TOL/TAZ 30/15 mg/kg. |
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| Cohort 4: ≥3 months to <2 years TOL/TAZ 18/9 or 30/15 mg/kg | Experimental | Participants ≥3 months to <2 years of age received a single dose of TOL/TAZ 18/9 mg/kg as a 60-minute infusion on Day 1. Participants in this cohort enrolled after interim analysis for Cohort 3 received TOL/TAZ 30/15 mg/kg. |
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| Cohort 5: birth to <3 months TOL/TAZ 20/10 mg/kg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftolozane/Tazobactam 1000/500 mg | Drug | A fixed dose combination (FDC) of 1000 mg ceftolozane and 500 mg tazobactam as a 60 minute infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Ceftolozane | Blood was collected for the determination of Cmax of ceftolozane. Cmax is expressed as geometric least-squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Maximum Plasma Concentration (Cmax) of Tazobactam | Blood was collected for the determination of Cmax of tazobactam. Cmax is expressed as geometric least-squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Time to Maximum Plasma Concentration (Tmax) of Ceftolozane | Blood was collected for the determination of Tmax of ceftolozane. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Time to Maximum Plasma Concentration (Tmax) of Tazobactam | Blood was collected for the determination of Tmax of tazobactam. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Plasma Concentration at the Last Quantifiable Concentration (Clast) of Ceftolozane | Blood was collected for the determination of Clast of ceftolozane. Clast is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30153232 | Derived | Bradley JS, Ang JY, Arrieta AC, Larson KB, Rizk ML, Caro L, Yang S, Yu B, Johnson MG, Rhee EG. Pharmacokinetics and Safety of Single Intravenous Doses of Ceftolozane/Tazobactam in Children With Proven or Suspected Gram-Negative Infection. Pediatr Infect Dis J. 2018 Nov;37(11):1130-1136. doi: 10.1097/INF.0000000000002170. |
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After interim analysis, dose level adjustments were made to some groups based on safety and pharmacokinetics targets. Thus, the initial 6 cohorts were expanded to a total of 9 cohorts for analysis.
Participants were screened for eligibility within 48 hours prior to study drug administration.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC | Participants ≥12 to <18 years of age received a single dose of ceftolozane/tazobactam (TOL/TAZ) 1000/500 mg FDC as a 60-minute infusion on Day 1. |
| FG001 | Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2017 |
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| Experimental |
Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of TOL/TAZ 20/10 mg/kg as a 60-minute infusion on Day 1. After interim analysis for Cohort 4, the original regimen of TOL/TAZ 12/6 mg/kg was changed to TOL/TAZ 20/10. |
|
| Cohort 6: birth to <3 months TOL/TAZ 12/6 or 20/10 mg/kg | Experimental | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance =20 - 49 mL/min/1.73 m^2 received a single dose of TOL/TAZ 12/6 mg/kg as a 60-minute infusion on Day 1; participants with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of TOL/TAZ 20/10 mg/kg as a 60-minute infusion on Day 1. After interim analysis for Cohort 4, the original regimen of TOL/TAZ 12/6 was changed to TOL/TAZ 20/10 mg/kg for participants with creatinine clearance ≥50 mL/min/1.73 m^2. |
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| Ceftolozane/Tazobactam 30/15 mg/kg | Drug | A FDC of 30 mg/kg of ceftolozane and 15 mg/kg of tazobactam as a 60 minute infusion. |
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| Ceftolozane/Tazobactam 20/10 mg/kg | Drug | A FDC of 20 mg/kg of ceftolozane and 10 mg/kg of tazobactam as a 60 minute infusion. |
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| Ceftolozane/Tazobactam 18/9 mg/kg | Drug | A FDC of 18 mg/kg of ceftolozane and 9 mg/kg of tazobactam as a 60 minute infusion. |
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| Ceftolozane/Tazobactam 12/6 mg/kg | Drug | A FDC of 12 mg/kg of ceftolozane and 6 mg/kg of tazobactam as a 60 minute infusion. |
|
| Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Plasma Concentration at the Last Quantifiable Concentration (Clast) of Tazobactam | Blood was collected for the determination of Clast of tazobactam. Clast is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Time of Last Sampling Point (Tlast) of Ceftolozane | Blood was collected for the determination of Tlast of ceftolozane. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Time of Last Sampling Point (Tlast) of Tazobactam | Blood was collected for the determination of Tlast of tazobactam. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Area Under the Plasma Concentration-Time Curve (AUClast) of Ceftolozane | Blood was collected for the determination of AUC from time zero to the last quantifiable concentration of ceftolozane. AUC0-last is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Area Under the Plasma Concentration-Time Curve (AUClast) of Tazobactam | Blood was collected for the determination of AUC from time zero to the last quantifiable concentration of tazobactam. AUC0-last is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Ceftolozane | Blood was collected for the determination of AUC from time zero extrapolated to infinity of ceftolozane. AUC0-inf is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Tazobactam | Blood was collected for the determination of AUC from time zero extrapolated to infinity of tazobactam. AUC0-inf is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Elimination Half-life (t1/2) of Ceftolozane | Blood was collected for the determination of t1/2 of ceftolozane. t1/2 is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Elimination Half-life (t1/2) of Tazobactam | Blood was collected for the determination of t1/2 of tazobactam. t1/2 is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Volume of Distribution at Steady State (Vss) of Ceftolozane | Blood was collected for the determination of Vss of ceftolozane. Vss is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Volume of Distribution at Steady State (Vss) of Tazobactam | Blood was collected for the determination of Vss of tazobactam. Vss is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Plasma Clearance (CL) of Ceftolozane | Blood was collected for the determination of CL of ceftolozane. CL is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Plasma Clearance (CL) of Tazobactam | Blood was collected for the determination of CL of tazobactam. CL is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
| Up to Day 10 |
| Number of Participants Who Discontinued the Study Due to an Adverse Event | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to Day 10 |
Participants ≥7 to <12 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| FG002 | Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| FG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| FG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| FG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| FG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| FG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| FG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC | Participants ≥12 to <18 years of age received a single dose of ceftolozane/tazobactam (TOL/TAZ) 1000/500 mg FDC as a 60-minute infusion on Day 1. |
| BG001 | Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg | Participants ≥7 to <12 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| BG002 | Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| BG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| BG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| BG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| BG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| BG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| BG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Maximum Plasma Concentration (Cmax) of Ceftolozane | Blood was collected for the determination of Cmax of ceftolozane. Cmax is expressed as geometric least-squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | μg/mL | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Maximum Plasma Concentration (Cmax) of Tazobactam | Blood was collected for the determination of Cmax of tazobactam. Cmax is expressed as geometric least-squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | μg/mL | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of Ceftolozane | Blood was collected for the determination of Tmax of ceftolozane. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Median | Full Range | Hours | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of Tazobactam | Blood was collected for the determination of Tmax of tazobactam. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Median | Full Range | Hours | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Plasma Concentration at the Last Quantifiable Concentration (Clast) of Ceftolozane | Blood was collected for the determination of Clast of ceftolozane. Clast is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Plasma Concentration at the Last Quantifiable Concentration (Clast) of Tazobactam | Blood was collected for the determination of Clast of tazobactam. Clast is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Time of Last Sampling Point (Tlast) of Ceftolozane | Blood was collected for the determination of Tlast of ceftolozane. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Median | Full Range | Hours | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Time of Last Sampling Point (Tlast) of Tazobactam | Blood was collected for the determination of Tlast of tazobactam. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Median | Full Range | Hours | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Area Under the Plasma Concentration-Time Curve (AUClast) of Ceftolozane | Blood was collected for the determination of AUC from time zero to the last quantifiable concentration of ceftolozane. AUC0-last is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Hours*μg/mL | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Area Under the Plasma Concentration-Time Curve (AUClast) of Tazobactam | Blood was collected for the determination of AUC from time zero to the last quantifiable concentration of tazobactam. AUC0-last is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Hours*μg/mL | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Ceftolozane | Blood was collected for the determination of AUC from time zero extrapolated to infinity of ceftolozane. AUC0-inf is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Hours*μg/mL | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Tazobactam | Blood was collected for the determination of AUC from time zero extrapolated to infinity of tazobactam. AUC0-inf is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Hours*μg/mL | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Elimination Half-life (t1/2) of Ceftolozane | Blood was collected for the determination of t1/2 of ceftolozane. t1/2 is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Elimination Half-life (t1/2) of Tazobactam | Blood was collected for the determination of t1/2 of tazobactam. t1/2 is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Volume of Distribution at Steady State (Vss) of Ceftolozane | Blood was collected for the determination of Vss of ceftolozane. Vss is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/kg | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Volume of Distribution at Steady State (Vss) of Tazobactam | Blood was collected for the determination of Vss of tazobactam. Vss is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/kg | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Plasma Clearance (CL) of Ceftolozane | Blood was collected for the determination of CL of ceftolozane. CL is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hour/kg | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Primary | Plasma Clearance (CL) of Tazobactam | Blood was collected for the determination of CL of tazobactam. CL is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale. | The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hour/kg | Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6. |
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| Secondary | Number of Participants With One or More Adverse Events | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | The safety population was all enrolled participants who received study drug. | Posted | Count of Participants | Participants | Up to Day 10 |
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| Secondary | Number of Participants Who Discontinued the Study Due to an Adverse Event | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | The safety population was all enrolled participants who received study drug. | Posted | Count of Participants | Participants | Up to Day 10 |
|
Up to Day 10
The safety population was all enrolled participants who received study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC | Participants ≥12 to <18 years of age received a single dose of ceftolozane/tazobactam (TOL/TAZ) 1000/500 mg FDC as a 60-minute infusion on Day 1. | 0 | 6 | 1 | 6 | 2 | 6 |
| EG001 | Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg | Participants ≥7 to <12 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. | 0 | 6 | 1 | 6 | 0 | 6 |
| EG002 | Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. | 0 | 5 | 1 | 5 | 1 | 5 |
| EG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. | 0 | 4 | 0 | 4 | 0 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device related sepsis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Waist circumference increased | Investigations | MedDRA version 17.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Weaning failure | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Device leakage | General disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 17.0 | Systematic Assessment |
|
The data generated in this clinical study are the exclusive property of the Sponsor and are confidential. The Sponsor will make all reasonable efforts to publish the results of the study in an appropriate peer-reviewed journal. Authorship on the primary publication of the results from this study will be based on contributions to study design, enrollment, data analysis, and interpretation of results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Apr 4, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C519491 | ceftolozane |
| D000078142 | Tazobactam |
| ID | Term |
|---|---|
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Male |
|
| White |
|
| Other |
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg |
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg |
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg |
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg |
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1.
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
|
|
| OG003 | Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg | Participants ≥2 to <7 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG004 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 18/9 mg/kg as a 60-minute infusion on Day 1. |
| OG005 | Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg | Participants ≥3 months to <2 years of age received a single dose of ceftolozane/tazobactam 30/15 mg/kg as a 60-minute infusion on Day 1. |
| OG006 | Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (>32 weeks gestation, 7 days postnatal) to <3 months of age received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
| OG007 | Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance of 20 - 49 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 12/6 mg/kg as a 60-minute infusion on Day 1. |
| OG008 | Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg | Participants from birth (≤32 weeks gestation, 7 days postnatal) to <3 months of age with creatinine clearance ≥50 mL/min/1.73 m^2 received a single dose of ceftolozane/tazobactam 20/10 mg/kg as a 60-minute infusion on Day 1. |
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