Trial Outcomes & Findings for Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010) (NCT NCT02266706)

NCT ID: NCT02266706

Last Updated: 2019-09-11

Results Overview

Blood was collected for the determination of Tlast of tazobactam.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 43 participants
• Primary outcome timeframe: 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.
• Results posted on: 2019-09-11

Participant Flow

Participants were screened for eligibility within 48 hours prior to study drug administration.

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.

Participant milestones

Measure	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study STARTED	6	7	4	4	1	7	8	2	4
Overall Study Treated	6	6	3	3	1	5	7	2	4
Overall Study COMPLETED	6	6	3	3	1	5	7	2	4
Overall Study NOT COMPLETED	0	1	1	1	0	2	1	0	0

Reasons for withdrawal

Measure	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study Withdrawal by Subject	0	1	1	0	0	1	0	0	0
Overall Study Screen failure	0	0	0	0	0	1	1	0	0
Overall Study Enrollment in another study	0	0	0	1	0	0	0	0	0

Baseline Characteristics

Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)

Baseline characteristics by cohort

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=6 Participants 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 n=7 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=4 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=4 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=7 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=8 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=4 Participants 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.	Total n=43 Participants Total of all reporting groups
Age, Continuous	16.1 Years STANDARD_DEVIATION 1.4 • n=5 Participants	8.5 Years STANDARD_DEVIATION 1.2 • n=7 Participants	5.5 Years STANDARD_DEVIATION 0.8 • n=5 Participants	4.8 Years STANDARD_DEVIATION 1.8 • n=4 Participants	0.9 Years STANDARD_DEVIATION 0.0 • n=21 Participants	0.9 Years STANDARD_DEVIATION 0.7 • n=10 Participants	0.1 Years STANDARD_DEVIATION 0.0 • n=115 Participants	0.1 Years STANDARD_DEVIATION 0.0 • n=6 Participants	0.2 Years STANDARD_DEVIATION 0.1 • n=6 Participants	4.8 Years STANDARD_DEVIATION 5.6 • n=64 Participants
Age, Customized Newborns (0-27days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	2 Participants n=6 Participants	4 Participants n=6 Participants	19 Participants n=64 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	16 Participants n=64 Participants
Age, Customized Adolescents (12-17 years)	6 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	6 Participants n=64 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants	22 Participants n=64 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	21 Participants n=64 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	8 Participants n=64 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants	7 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	31 Participants n=64 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	4 Participants n=64 Participants

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Maximum Plasma Concentration (Cmax) of Ceftolozane	63.5 μg/mL Interval 50.2 to 80.4	56.2 μg/mL Interval 45.3 to 69.7	51.4 μg/mL Interval 37.9 to 69.7	96.6 μg/mL Interval 71.2 to 131.0	50.5 μg/mL Interval 29.8 to 85.6	91.3 μg/mL Interval 72.1 to 116.0	45.0 μg/mL Interval 36.3 to 55.9	34.9 μg/mL Interval 24.1 to 50.7	45.2 μg/mL Interval 33.3 to 61.2

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Maximum Plasma Concentration (Cmax) of Tazobactam	14.0 μg/mL Interval 8.59 to 22.9	9.25 μg/mL Interval 5.92 to 14.5	15.7 μg/mL Interval 8.36 to 29.6	24.8 μg/mL Interval 13.2 to 46.6	11.6 μg/mL Interval 3.88 to 34.7	22.4 μg/mL Interval 13.8 to 36.6	11.7 μg/mL Interval 7.48 to 18.3	6.87 μg/mL Interval 3.17 to 14.9	12.1 μg/mL Interval 6.43 to 22.7

PRIMARY outcome

Timeframe: 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.

Population: 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.

Blood was collected for the determination of Tmax of ceftolozane.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Time to Maximum Plasma Concentration (Tmax) of Ceftolozane	1.02 Hours Interval 1.0 to 1.1	1.07 Hours Interval 0.58 to 1.13	1.02 Hours Interval 1.02 to 1.03	1.03 Hours Interval 1.03 to 1.12	1.00 Hours Interval 1.0 to 1.0	1.05 Hours Interval 0.58 to 1.95	1.08 Hours Interval 0.95 to 1.9	1.80 Hours Interval 1.03 to 2.57	1.07 Hours Interval 1.07 to 1.18

PRIMARY outcome

Timeframe: 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.

Population: 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.

Blood was collected for the determination of Tmax of tazobactam.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Time to Maximum Plasma Concentration (Tmax) of Tazobactam	1.00 Hours Interval 0.5 to 1.1	1.07 Hours Interval 0.58 to 1.13	1.02 Hours Interval 1.02 to 1.03	1.03 Hours Interval 1.03 to 1.12	1.00 Hours Interval 1.0 to 1.0	1.05 Hours Interval 0.58 to 1.95	1.08 Hours Interval 0.95 to 1.33	3.89 Hours Interval 1.03 to 6.75	1.07 Hours Interval 1.07 to 1.18

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Plasma Concentration at the Last Quantifiable Concentration (Clast) of Ceftolozane	4.01 μg/mL Geometric Coefficient of Variation 40.4	2.85 μg/mL Geometric Coefficient of Variation 37.3	2.47 μg/mL Geometric Coefficient of Variation 29.1	5.69 μg/mL Geometric Coefficient of Variation 59.5	2.53 μg/mL Geometric Coefficient of Variation NA Cannot be calculated for n=1	5.72 μg/mL Geometric Coefficient of Variation 96.1	8.70 μg/mL Geometric Coefficient of Variation 49.1	10.2 μg/mL Geometric Coefficient of Variation 49.2	6.26 μg/mL Geometric Coefficient of Variation 39.2

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Plasma Concentration at the Last Quantifiable Concentration (Clast) of Tazobactam	0.232 μg/mL Geometric Coefficient of Variation 52.2	0.420 μg/mL Geometric Coefficient of Variation 188.6	0.137 μg/mL Geometric Coefficient of Variation 24.1	0.327 μg/mL Geometric Coefficient of Variation 62.7	0.224 μg/mL Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.401 μg/mL Geometric Coefficient of Variation 90.5	0.657 μg/mL Geometric Coefficient of Variation 169.2	3.66 μg/mL Geometric Coefficient of Variation 57.6	0.266 μg/mL Geometric Coefficient of Variation 81.3

PRIMARY outcome

Timeframe: 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.

Population: 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.

Blood was collected for the determination of Tlast of ceftolozane.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Time of Last Sampling Point (Tlast) of Ceftolozane	6.00 Hours Interval 5.85 to 6.03	6.01 Hours Interval 5.82 to 6.15	6.08 Hours Interval 5.85 to 6.25	5.77 Hours Interval 5.72 to 5.93	6.00 Hours Interval 6.0 to 6.0	6.00 Hours Interval 5.72 to 6.75	6.01 Hours Interval 5.88 to 6.18	6.40 Hours Interval 6.05 to 6.75	5.85 Hours Interval 5.72 to 6.02

PRIMARY outcome

Timeframe: 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.

Population: 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.

Blood was collected for the determination of Tlast of tazobactam.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Time of Last Sampling Point (Tlast) of Tazobactam	4.15 Hours Interval 4.0 to 6.0	3.10 Hours Interval 2.02 to 4.15	5.85 Hours Interval 4.03 to 6.08	5.72 Hours Interval 3.85 to 5.93	4.00 Hours Interval 4.0 to 4.0	5.02 Hours Interval 4.02 to 5.75	5.95 Hours Interval 2.18 to 6.1	6.40 Hours Interval 6.05 to 6.75	5.85 Hours Interval 5.72 to 6.02

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Area Under the Plasma Concentration-Time Curve (AUClast) of Ceftolozane	124 Hours*μg/mL Interval 103.0 to 150.0	102 Hours*μg/mL Interval 86.2 to 121.0	94.2 Hours*μg/mL Interval 74.1 to 120.0	172 Hours*μg/mL Interval 135.0 to 219.0	98.8 Hours*μg/mL Interval 65.1 to 150.0	178 Hours*μg/mL Interval 148.0 to 214.0	131 Hours*μg/mL Interval 111.0 to 155.0	118 Hours*μg/mL Interval 88.2 to 159.0	119 Hours*μg/mL Interval 93.7 to 151.0

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Area Under the Plasma Concentration-Time Curve (AUClast) of Tazobactam	17.3 Hours*μg/mL Interval 10.7 to 27.9	9.69 Hours*μg/mL Interval 6.27 to 15.0	17.6 Hours*μg/mL Interval 9.53 to 32.7	28.5 Hours*μg/mL Interval 15.4 to 52.8	14.8 Hours*μg/mL Interval 5.08 to 42.9	28.9 Hours*μg/mL Interval 18.0 to 46.6	21.3 Hours*μg/mL Interval 13.8 to 33.0	21.6 Hours*μg/mL Interval 10.2 to 45.9	21.9 Hours*μg/mL Interval 11.8 to 40.6

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Ceftolozane	133 Hours*μg/mL Interval 104.0 to 171.0	107 Hours*μg/mL Interval 85.7 to 135.0	99.4 Hours*μg/mL Interval 72.2 to 137.0	186 Hours*μg/mL Interval 135.0 to 255.0	103 Hours*μg/mL Interval 59.4 to 180.0	202 Hours*μg/mL Interval 158.0 to 259.0	164 Hours*μg/mL Interval 131.0 to 205.0	165 Hours*μg/mL Interval 112.0 to 244.0	137 Hours*μg/mL Interval 99.6 to 189.0

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=5 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=1 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Tazobactam	17.5 Hours*μg/mL Interval 12.6 to 24.2	10.2 Hours*μg/mL Interval 6.68 to 15.5	17.8 Hours*μg/mL Interval 11.7 to 27.0	28.9 Hours*μg/mL Interval 19.0 to 43.9	14.9 Hours*μg/mL Interval 7.21 to 30.9	29.9 Hours*μg/mL Interval 21.6 to 41.4	24.9 Hours*μg/mL Interval 18.0 to 34.4	77.6 Hours*μg/mL Interval 37.5 to 161.0	22.3 Hours*μg/mL Interval 14.7 to 34.0

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Elimination Half-life (t1/2) of Ceftolozane	1.45 Hours Geometric Coefficient of Variation 16.7	1.29 Hours Geometric Coefficient of Variation 9.6	1.34 Hours Geometric Coefficient of Variation 14.0	1.48 Hours Geometric Coefficient of Variation 35.5	1.30 Hours Geometric Coefficient of Variation NA Cannot be calculated for n=1	1.63 Hours Geometric Coefficient of Variation 69.0	2.21 Hours Geometric Coefficient of Variation 37.6	3.14 Hours Geometric Coefficient of Variation 0.9	1.73 Hours Geometric Coefficient of Variation 29.7

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=5 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=1 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Elimination Half-life (t1/2) of Tazobactam	0.702 Hours Geometric Coefficient of Variation 38.7	0.544 Hours Geometric Coefficient of Variation 3.1	0.719 Hours Geometric Coefficient of Variation 29.7	0.770 Hours Geometric Coefficient of Variation 34.2	0.538 Hours Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.815 Hours Geometric Coefficient of Variation 85.1	1.09 Hours Geometric Coefficient of Variation 32.0	3.03 Hours Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.875 Hours Geometric Coefficient of Variation 20.4

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Volume of Distribution at Steady State (Vss) of Ceftolozane	0.274 L/kg Geometric Coefficient of Variation 25.7	0.296 L/kg Geometric Coefficient of Variation 22.0	0.331 L/kg Geometric Coefficient of Variation 15.6	0.312 L/kg Geometric Coefficient of Variation 19.5	0.282 L/kg Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.340 L/kg Geometric Coefficient of Variation 21.1	0.394 L/kg Geometric Coefficient of Variation 12.6	0.344 L/kg Geometric Coefficient of Variation 36.6	0.388 L/kg Geometric Coefficient of Variation 26.9

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=5 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=1 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Volume of Distribution at Steady State (Vss) of Tazobactam	0.474 L/kg Geometric Coefficient of Variation 69.6	0.740 L/kg Geometric Coefficient of Variation 30.2	0.488 L/kg Geometric Coefficient of Variation 32.0	0.513 L/kg Geometric Coefficient of Variation 49.2	0.421 L/kg Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.574 L/kg Geometric Coefficient of Variation 36.2	0.668 L/kg Geometric Coefficient of Variation 19.8	0.338 L/kg Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.667 L/kg Geometric Coefficient of Variation 29.3

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=6 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Plasma Clearance (CL) of Ceftolozane	0.146 L/hour/kg Geometric Coefficient of Variation 27.0	0.168 L/hour/kg Geometric Coefficient of Variation 21.3	0.181 L/hour/kg Geometric Coefficient of Variation 3.8	0.162 L/hour/kg Geometric Coefficient of Variation 31.1	0.176 L/hour/kg Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.149 L/hour/kg Geometric Coefficient of Variation 43.2	0.118 L/hour/kg Geometric Coefficient of Variation 36.0	0.0723 L/hour/kg Geometric Coefficient of Variation 32.2	0.147 L/hour/kg Geometric Coefficient of Variation 6.8

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=5 Participants 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 n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=5 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=1 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=3 Participants 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.
Plasma Clearance (CL) of Tazobactam	0.556 L/hour/kg Geometric Coefficient of Variation 53.9	0.886 L/hour/kg Geometric Coefficient of Variation 23.1	0.506 L/hour/kg Geometric Coefficient of Variation 42.0	0.519 L/hour/kg Geometric Coefficient of Variation 44.8	0.611 L/hour/kg Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.502 L/hour/kg Geometric Coefficient of Variation 34.7	0.385 L/hour/kg Geometric Coefficient of Variation 34.1	0.0760 L/hour/kg Geometric Coefficient of Variation NA Cannot be calculated for n=1	0.452 L/hour/kg Geometric Coefficient of Variation 24.9

SECONDARY outcome

Timeframe: Up to Day 10

Population: The safety population was all enrolled participants who received study drug.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=6 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=7 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=4 Participants 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.
Number of Participants With One or More Adverse Events	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10

Population: The safety population was all enrolled participants who received study drug.

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.

Outcome measures

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=6 Participants 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 n=6 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 Participants 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 Participants 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 Participants 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=7 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 Participants 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=4 Participants 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.
Number of Participants Who Discontinued the Study Due to an Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=6 participants at risk 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 n=6 participants at risk 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 participants at risk 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 participants at risk 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 participants at risk 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 participants at risk 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=7 participants at risk 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 participants at risk 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=4 participants at risk 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.
Infections and infestations Device related sepsis	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	20.0% 1/5 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	16.7% 1/6 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.

Other adverse events

Measure	Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC n=6 participants at risk 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 n=6 participants at risk 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 18/9 mg/kg n=3 participants at risk 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.	Cohort 3: ≥2 to <7 Years TOL/TAZ 30/15 mg/kg n=3 participants at risk 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 18/9 mg/kg n=1 participants at risk 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.	Cohort 4: ≥3 Months to <2 Years TOL/TAZ 30/15 mg/kg n=5 participants at risk 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.	Cohort 5: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=7 participants at risk 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.	Cohort 6: Birth to <3 Months TOL/TAZ 12/6 mg/kg n=2 participants at risk 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.	Cohort 6: Birth to <3 Months TOL/TAZ 20/10 mg/kg n=4 participants at risk 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.
Investigations Waist circumference increased	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	50.0% 1/2 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Cardiac disorders Bradycardia	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	33.3% 1/3 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Cardiac disorders Tachycardia	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	33.3% 1/3 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	14.3% 1/7 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	50.0% 1/2 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Nervous system disorders Convulsion	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	20.0% 1/5 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Nervous system disorders Hypokinesia	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	50.0% 1/2 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Eye disorders Periorbital oedema	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	14.3% 1/7 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	100.0% 1/1 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	20.0% 1/5 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Gastrointestinal disorders Constipation	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	14.3% 1/7 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	33.3% 1/3 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	20.0% 1/5 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	20.0% 1/5 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	14.3% 1/7 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	50.0% 1/2 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Injury, poisoning and procedural complications Weaning failure	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	14.3% 1/7 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Vascular disorders Hypertension	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	20.0% 1/5 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
General disorders Device dislocation	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	20.0% 1/5 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
General disorders Device leakage	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	20.0% 1/5 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/2 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/6 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/3 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/5 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/7 • Up to Day 10 The safety population was all enrolled participants who received study drug.	50.0% 1/2 • Number of events 1 • Up to Day 10 The safety population was all enrolled participants who received study drug.	0.00% 0/4 • Up to Day 10 The safety population was all enrolled participants who received study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER