Safety and Pharmacokinetics of Ceftolozane/Tazobactam in... | NCT04223752 | Trialant
NCT04223752
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 22, 2025Actual
Enrollment
41Actual
Phase
Phase 1
Conditions
Nosocomial Pneumonia
Interventions
Ceftolozane/Tazobactam
Countries
United States
Chile
Colombia
Estonia
Greece
Mexico
Russia
Spain
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04223752
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7625A-036
Secondary IDs
ID
Type
Description
Link
MK-7625A-036
Other Identifier
MSD Protocol Number
2022-501110-56-00
Registry Identifier
EU CT
U1111-1279-4959
Registry Identifier
UTN
2018-004704-19
EudraCT Number
Brief Title
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
Official Title
A Phase 1, Open-label, Non-comparative, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Ceftolozane/Tazobactam (MK-7625A) in Pediatric Participants With Nosocomial Pneumonia
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 17, 2020Actual
Primary Completion Date
Sep 14, 2024Actual
Completion Date
Sep 14, 2024Actual
First Submitted Date
Jan 8, 2020
First Submission Date that Met QC Criteria
Jan 8, 2020
First Posted Date
Jan 10, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Sep 2, 2025
Results First Submitted that Met QC Criteria
Sep 2, 2025
Results First Posted Date
Sep 22, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 2, 2025
Last Update Posted Date
Sep 22, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia (NP).
Detailed Description
Not provided
Conditions Module
Conditions
Nosocomial Pneumonia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
41Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Experimental
Participants 12 to <18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days.
Drug: Ceftolozane/Tazobactam
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Experimental
Participants 7 to <12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Drug: Ceftolozane/Tazobactam
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Experimental
Participants 2 to <7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Drug: Ceftolozane/Tazobactam
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Experimental
Participants 3 months to <2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Drug: Ceftolozane/Tazobactam
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Experimental
Participants from birth to <3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ceftolozane/Tazobactam
Drug
Participants 12 to <18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.
Participants <12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Any Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants experiencing any AE was reported for each arm.
Up to 31 days
Percentage of Participants With Any Serious AEs (SAEs)
An SAE was defined as any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event. The percentage of participants with any SAE was reported for each arm.
Up to 31 days
Percentage of Participants With Any Drug-related AEs
A drug-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention. The percentage of participants with any drug related AEs was reported for each arm.
Up to 31 days
Percentage of Participants With Any Drug-related SAEs
A drug-related SAE was defined any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event, that is considered related to the study intervention. The percentage of participants with any drug related SAEs was reported for each arm.
Up to 31 days
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
Secondary Outcomes
Measure
Description
Time Frame
Plasma Concentrations of Ceftolozane
The plasma concentrations of ceftolozane were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of ceftolozane in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care [SOC] antibiotic therapy for proven or suspected NP.
If male, is abstinent from heterosexual intercourse, or agrees to use contraception during the intervention period and for ≥30 days after the last dose of study intervention.
If female, is not pregnant or breastfeeding, or is not a woman of childbearing potential (WOCBP), or is a WOCBP using acceptable contraception, is a WOCBP with negative urine or serum pregnancy test within 48 hours of the first dose of study intervention, or is abstinent from heterosexual intercourse.
Exclusion Criteria:
Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any β-lactam antibacterial.
Participants 3 months to <18 years of age: has moderate to severe impairment of renal function, defined as an estimated creatinine clearance (CrCL) <50 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration.
Participants <3 months of age: has CrCL <20 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration.
Is receiving or is anticipated to receive piperacillin/tazobactam while receiving ceftolozane/tazobactam or has received piperacillin/tazobactam within 24 hours prior to the first dose of ceftolozane/tazobactam.
Has participated in any clinical study of a therapeutic investigational product within 30 days prior to the first dose of ceftolozane/tazobactam.
Has previous participation in any study of ceftolozane or ceftolozane/tazobactam.
Has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of study data.
Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure or septic shock.
One participant was enrolled in error in the Group 5 arm and was excluded from the All participants as treated (APaT) population; the participant did not receive study intervention.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
FG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Dec 12, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Ceftolozane/Tazobactam
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
MK-7625A
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with AEs leading to discontinuation of study intervention was reported for each arm.
Up to 14 days
Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Ceftolozane
AUC0-8 was defined as a measure of ceftolozane exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at pre-specified timepoints to determine the AUC0-8 of ceftolozane in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Ceftolozane
Cmax was defined as the maximum concentration of ceftolozane observed in plasma. Blood samples were collected at pre-specified timepoints to determine the Cmax of ceftolozane in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Elimination Half-life (t1/2) of Plasma Ceftolozane
Elimination half-life (t1/2) was defined as the time needed to reduce the level of ceftolozane in the blood by one-half (1/2). Blood samples collected at pre-specified timepoints were used to determine the apparent terminal half-life (t1/2) of ceftolozane in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Clearance (CL) of Plasma Ceftolozane
CL was defined as the total clearance of ceftolozane in plasma over time, assessed as the rate at which ceftolozane was removed from the plasma. Blood samples were collected at pre-specified timepoints to determine the CL of ceftolozane in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Volume of Distribution (Vd) of Plasma Ceftolozane
Vd was defined as the distributed volume of study drug in plasma at steady state. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. Blood samples were collected at pre-specified timepoints to determine the Vd of ceftolozane in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Plasma Concentrations of Tazobactam
The plasma concentrations of tazobactam were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of tazobactam in participants receiving ceftolozane/tazobactam. No data were calculated for a timepoint if >50% of samples were below limit of quantification (BLOQ).
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Tazobactam
AUC0-8 was defined as a measure of tazobactam exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at pre-specified timepoints to determine the AUC0-8 of tazobactam in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Tazobactam
Cmax was defined as the maximum concentration of tazobactam observed in plasma. Blood samples were collected at pre-specified timepoints to determine the Cmax of tazobactam in participants receiving ceftolozane/tazobactam. The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Elimination Half-life (t1/2) of Plasma Tazobactam
Elimination half-life (t1/2) was defined as the time needed to reduce the level of tazobactam in the blood by one-half (1/2). Blood samples collected at pre-specified timepoints were used to determine the apparent terminal half-life (t1/2) of tazobactam in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Clearance (CL) of Plasma Tazobactam
CL was defined as the total clearance of tazobactam in plasma over time, assessed as the rate at which tazobactam was removed from the plasma. Blood samples were collected at pre-specified timepoints to determine the CL of tazobactam in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Volume of Distribution (Vd) of Plasma Tazobactam
Vd is defined as the distributed volume of study drug in plasma at steady state. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. Blood samples were collected at pre-specified timepoints to determine the Vd of tazobactam in participants receiving ceftolozane/tazobactam.
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Rochester
Minnesota
55902
United States
Montefiore Medical Center [Bronx, NY] ( Site 1313)
New York
New York
10467
United States
Sanford Children's Hospital ( Site 1301)
Sioux Falls
South Dakota
57105
United States
West Virginia University ( Site 1310)
Morgantown
West Virginia
26506
United States
Children's Wisconsin ( Site 1321)
Milwaukee
Wisconsin
53226
United States
Hospital Roberto del Río ( Site 1400)
Santiago
Region M. de Santiago
8380418
Chile
Hospital General de Medellin ( Site 1503)
Medellín
Antioquia
0500515
Colombia
Ciensalud Ips S A S ( Site 1501)
Barranquilla
Atlántico
08001
Colombia
Clinica de la Costa S.A.S. ( Site 1500)
Barranquilla
Atlántico
080020
Colombia
Oncomédica S.A.S ( Site 1506)
Montería
Departamento de Córdoba
230002
Colombia
SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201)
Tallinn
Harju
13419
Estonia
SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200)
Tartu
Tartu
50406
Estonia
Hippokration General Hospital of Thessaloniki ( Site 0400)
Thessaloniki
Central Macedonia
546 42
Greece
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 1602)
Mexico City
Mexico City
04530
Mexico
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 1600)
Mexico City
Mexico City
06720
Mexico
Morozovskaya Children City Clinical Hospital ( Site 0901)
Moscow
Moscow
119049
Russia
St. Olga Children City Hospital ( Site 0906)
Saint Petersburg
Sankt-Peterburg
194156
Russia
Smolensk Regional Clinical Hospital ( Site 0903)
Smolensk
Smolensk Oblast
214018
Russia
Hospital Universitario Sant Joan de Deu ( Site 1100)
Esplugues de Llobregat
Barcelona
08950
Spain
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205)
Dnipro
Dnipropetrovsk Oblast
49100
Ukraine
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204)
Ivano-Frankivsk
Ivano-Frankivsk Oblast
76018
Ukraine
Kharkiv City Children Hospital 16 ( Site 1200)
Kharkiv
Kharkiv Oblast
61075
Ukraine
Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203)
Kyiv
Kyivska Oblast
04050
Ukraine
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
FG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
FG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
FG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
FG0008 subjects
FG0017 subjects
FG0028 subjects
FG00310 subjects
FG0048 subjects
Treated
FG0008 subjects
FG0017 subjects
FG0028 subjects
FG00310 subjects
FG0047 subjects
COMPLETED
FG0008 subjects
FG0017 subjects
FG0028 subjects
FG0038 subjects
FG0046 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0042 subjects
Type
Comment
Reasons
Participant enrolled in error
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
BG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
BG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
BG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
BG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0017
BG0028
BG00310
BG0048
BG00541
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00014.345± 1.6408
BG0019.709± 1.9100
BG0023.185± 0.7430
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Any Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants experiencing any AE was reported for each arm.
The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 31 days
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00050.0± 15.7(15.7 to 84.3)
OG00171.4± 29.0(29.0 to 96.3)
OG00275.0± 34.9(34.9 to 96.8)
Primary
Percentage of Participants With Any Serious AEs (SAEs)
An SAE was defined as any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event. The percentage of participants with any SAE was reported for each arm.
The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 31 days
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Primary
Percentage of Participants With Any Drug-related AEs
A drug-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention. The percentage of participants with any drug related AEs was reported for each arm.
The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 31 days
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Primary
Percentage of Participants With Any Drug-related SAEs
A drug-related SAE was defined any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event, that is considered related to the study intervention. The percentage of participants with any drug related SAEs was reported for each arm.
The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 31 days
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Primary
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with AEs leading to discontinuation of study intervention was reported for each arm.
The analysis population consisted of participants who received any dose (including partial doses) of ceftolozane/tazobactam.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 14 days
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Plasma Concentrations of Ceftolozane
The plasma concentrations of ceftolozane were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of ceftolozane in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 1 dose of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
Posted
Geometric Mean
Geometric Coefficient of Variation
mg/L
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Ceftolozane
AUC0-8 was defined as a measure of ceftolozane exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at pre-specified timepoints to determine the AUC0-8 of ceftolozane in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg*hr/mL
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Secondary
Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Ceftolozane
Cmax was defined as the maximum concentration of ceftolozane observed in plasma. Blood samples were collected at pre-specified timepoints to determine the Cmax of ceftolozane in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Elimination Half-life (t1/2) of Plasma Ceftolozane
Elimination half-life (t1/2) was defined as the time needed to reduce the level of ceftolozane in the blood by one-half (1/2). Blood samples collected at pre-specified timepoints were used to determine the apparent terminal half-life (t1/2) of ceftolozane in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Clearance (CL) of Plasma Ceftolozane
CL was defined as the total clearance of ceftolozane in plasma over time, assessed as the rate at which ceftolozane was removed from the plasma. Blood samples were collected at pre-specified timepoints to determine the CL of ceftolozane in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Volume of Distribution (Vd) of Plasma Ceftolozane
Vd was defined as the distributed volume of study drug in plasma at steady state. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. Blood samples were collected at pre-specified timepoints to determine the Vd of ceftolozane in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of ceftolozane or tazobactam.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Secondary
Plasma Concentrations of Tazobactam
The plasma concentrations of tazobactam were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of tazobactam in participants receiving ceftolozane/tazobactam. No data were calculated for a timepoint if >50% of samples were below limit of quantification (BLOQ).
The analysis population consisted of participants who received at least 1 dose of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Posted
Geometric Mean
Geometric Coefficient of Variation
mg/L
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Tazobactam
AUC0-8 was defined as a measure of tazobactam exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at pre-specified timepoints to determine the AUC0-8 of tazobactam in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg*hr/mL
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Tazobactam
Cmax was defined as the maximum concentration of tazobactam observed in plasma. Blood samples were collected at pre-specified timepoints to determine the Cmax of tazobactam in participants receiving ceftolozane/tazobactam. The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Elimination Half-life (t1/2) of Plasma Tazobactam
Elimination half-life (t1/2) was defined as the time needed to reduce the level of tazobactam in the blood by one-half (1/2). Blood samples collected at pre-specified timepoints were used to determine the apparent terminal half-life (t1/2) of tazobactam in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Clearance (CL) of Plasma Tazobactam
CL was defined as the total clearance of tazobactam in plasma over time, assessed as the rate at which tazobactam was removed from the plasma. Blood samples were collected at pre-specified timepoints to determine the CL of tazobactam in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
Secondary
Volume of Distribution (Vd) of Plasma Tazobactam
Vd is defined as the distributed volume of study drug in plasma at steady state. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. Blood samples were collected at pre-specified timepoints to determine the Vd of tazobactam in participants receiving ceftolozane/tazobactam.
The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
ID
Title
Description
OG000
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
OG001
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG002
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Time Frame
Up to approximately 31 days
Description
Analysis population for All-cause mortality consists of all enrolled participants. Serious and Other adverse events include all participants who received any dose (including partial doses) of ceftolozane/tazobactam.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group 1: 12 to <18 Years
Participants 12 to <18 years of age with nosocomial pneumonia received intravenous (IV) ceftolozane 2g and tazobactam 1g every 8 hours for 8-14 days.
0
8
1
8
4
8
EG001
Group 2: 7 to <12 Years
Participants 7 to <12 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
0
7
2
7
5
7
EG002
Group 3: 2 to <7 Years
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
0
8
0
8
6
8
EG003
Group 4: 3 Months to <2 Years
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
2
10
3
10
9
10
EG004
Group 5: Birth to <3 Months
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
1
8
2
7
6
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiogenic shock
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected7 at risk
Myocardial depression
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Omentitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Candida infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Benign mediastinal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG0033 events3 affected10 at risk
EG0040 events0 affected7 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Cardiac dysfunction
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Anal erythema
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Anal ulcer
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Face oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hyperthermia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Withdrawal syndrome
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Candida infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Systemic mycosis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Gastrointestinal anastomotic leak
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Base excess decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Eosinophil count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Myelocyte count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Platelet count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected8 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Renal lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Device breakage
Product Issues
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Nephropathy toxic
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected8 at risk
EG003
Milia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG00012.5± 0.3(0.3 to 52.7)
OG00128.6± 3.7(3.7 to 71.0)
OG0020.0± 0.0(0.0 to 36.9)
OG00330.0± 6.7(6.7 to 65.2)
OG00428.6± 3.7(3.7 to 71.0)
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.0(0.0 to 36.9)
OG0010.0± 0.0(0.0 to 41.0)
OG0020.0± 0.0(0.0 to 36.9)
OG0030.0± 0.0(0.0 to 30.8)
OG00414.3± 0.4(0.4 to 57.9)
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.0(0.0 to 36.9)
OG0010.0± 0.0(0.0 to 41.0)
OG0020.0± 0.0(0.0 to 36.9)
OG0030.0± 0.0(0.0 to 30.8)
OG0040.0± 0.0(0.0 to 41.0)
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.0(0.0 to 36.9)
OG0010.0± 0.0(0.0 to 41.0)
OG0020.0± 0.0(0.0 to 36.9)
OG0030.0± 0.0(0.0 to 30.8)
OG0040.0± 0.0(0.0 to 41.0)
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0016
OG0027
OG00310
OG0047
Title
Denominators
Categories
1 hr post start of infusion
Title
Measurements
OG00093.0± 18.9(18.9 to )
OG00170.3± 28.6(28.6 to )
OG00267.6± 46.9(46.9 to )
OG00354.3± 203(203 to )
OG00478.5± 19.0(19.0 to )
4-5 hrs post start of infusion
Title
Measurements
OG00018.8± 20.1(20.1 to )
OG00113.4± 55.6(55.6 to )
OG00210.5± 52.4(52.4 to )
OG003
7-8 hrs post start of infusion
Title
Measurements
OG0006.61± 27.2(27.2 to )
OG0014.53± 53.1(53.1 to )
OG0022.79± 59.9(59.9 to )
OG003
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG000260± 18.4(18.4 to )
OG001230± 27.2(27.2 to )
OG002202± 22.5(22.5 to )
OG003282± 42.8(42.8 to )
OG004360± 29.7(29.7 to )
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG000116± 17.8(17.8 to )
OG001121± 22.7(22.7 to )
OG002107± 15.9(15.9 to )
OG003113± 18.9(18.9 to )
OG004107± 16.0(16.0 to )
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG0001.87± 8.60(8.60 to )
OG0011.56± 16.2(16.2 to )
OG0021.33± 15.7(15.7 to )
OG0031.79± 39.2(39.2 to )
OG0042.60± 24.6(24.6 to )
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG0007.68± 18.4(18.4 to )
OG0014.95± 53.3(53.3 to )
OG0022.54± 36.1(36.1 to )
OG0030.919± 62.1(62.1 to )
OG0040.378± 57.5(57.5 to )
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG00016.2± 18.8(18.8 to )
OG0018.35± 50.0(50.0 to )
OG0023.97± 17.0(17.0 to )
OG0032.13± 36.3(36.3 to )
OG0041.36± 34.8(34.8 to )
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0016
OG0027
OG00310
OG0047
Title
Denominators
Categories
1 hr post start of infusion
Title
Measurements
OG00018.6± 22.4
OG00115.5± 43.0
OG00215.0± 66.6
OG00310.2± 747
OG00422.2± 35.5
4-5 hrs post start of infusion
Title
Measurements
OG0000.876± 38.3
OG0010.788± 157
OG0020.404± 122
OG003
7-8 hrs post start of infusion
Title
Measurements
OG0000.152± 68.4
OG0010.181± 183
OG002NA± NANA= Plasma concentration was not calculated because \>50% of samples were BLOQ.
OG003
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG00046.7± 25.5(25.5 to )
OG00150.1± 42.7(42.7 to )
OG00242.7± 33.8(33.8 to )
OG00358.3± 50.5(50.5 to )
OG00472.5± 35.0(35.0 to )
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG00036.7± 29.6(29.6 to )
OG00139.4± 34.1(34.1 to )
OG00234.2± 24.5(24.5 to )
OG00338.1± 29.1(29.1 to )
OG00437.9± 14.5(14.5 to )
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG0001.07± 6.59(6.59 to )
OG0010.932± 27.8(27.8 to )
OG0020.748± 22.9(22.9 to )
OG0030.930± 38.9(38.9 to )
OG0041.23± 31.6(31.6 to )
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.
Units
Counts
Participants
OG0008
OG0017
OG0027
OG00310
OG0047
Title
Denominators
Categories
Title
Measurements
OG00021.4± 25.5(25.5 to )
OG00111.4± 67.6(67.6 to )
OG0026.00± 45.9(45.9 to )
OG0032.22± 68.5(68.5 to )
OG0040.938± 58.2(58.2 to )
Participants 2 to <7 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG003
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to <2 years of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and tazobactam 20 mg/kg every 8 hours for 8-14 days.
OG004
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to <3 months of age with nosocomial pneumonia received IV ceftolozane 40 mg/kg and 20 mg/kg tazobactam every 8 hours for 8-14 days.