Trial Outcomes & Findings for Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants. (NCT NCT04126031)
NCT ID: NCT04126031
Last Updated: 2024-03-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
2 hours post dose on Day 1
Results posted on
2024-03-26
Participant Flow
A total of 52 participants were screened, out of which 4 participants were screen failures and 48 were enrolled to the study. 27 participants in Part A and 21 participants in Part B.
Participant milestones
| Measure |
Part A: Cohort 1
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part B: Cohort 1
On Day 1 participants aged 28days to \<3 months old received a single IV infusion of CAZ-AVI 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 2
On Day 1 participants aged \>= 37weeks and \<= 28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 3
On Day 1 participants aged \>=26weeks to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
|---|---|---|---|---|---|---|
|
Part A
STARTED
|
10
|
8
|
9
|
0
|
0
|
0
|
|
Part A
Treated
|
9
|
8
|
8
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
9
|
8
|
8
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
8
|
5
|
8
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
8
|
4
|
6
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Part A: Cohort 1
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part B: Cohort 1
On Day 1 participants aged 28days to \<3 months old received a single IV infusion of CAZ-AVI 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 2
On Day 1 participants aged \>= 37weeks and \<= 28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 3
On Day 1 participants aged \>=26weeks to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
|---|---|---|---|---|---|---|
|
Part A
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part A
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part B
Pre-existing hypertransaminasemia
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
Baseline characteristics by cohort
| Measure |
Part A: Cohort 1
n=9 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part B: Cohort 1
n=8 Participants
On Day 1 participants aged 28days to \<3 months old received a single IV infusion of CAZ-AVI 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 2
n=5 Participants
On Day 1 participants aged \>= 37weeks and \<= 28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26weeks to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.0 Days
STANDARD_DEVIATION 15.73 • n=5 Participants
|
19.3 Days
STANDARD_DEVIATION 9.00 • n=7 Participants
|
14.6 Days
STANDARD_DEVIATION 7.46 • n=5 Participants
|
51.1 Days
STANDARD_DEVIATION 18.16 • n=4 Participants
|
15.80 Days
STANDARD_DEVIATION 7.63 • n=21 Participants
|
17.8 Days
STANDARD_DEVIATION 8.99 • n=10 Participants
|
31.13 Days
STANDARD_DEVIATION 22.19 • n=115 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
00 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
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 2 hours post dose on Day 1Population: The Pharmacokinetic (PK) analysis set for Part A was defined as participants who received a single IV dose of CAZ-AVI in Part A.
Outcome measures
| Measure |
Part A: Cohort 1
n=9 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A
Ceftazidime
|
104544.4 Nanogram per milliliter
Standard Deviation 113161.34 • Interval 113161.34 to
|
35537.5 Nanogram per milliliter
Standard Deviation 13473.88 • Interval 13473.88 to
|
53212.5 Nanogram per milliliter
Standard Deviation 25972.32 • Interval 25972.32 to
|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A
Avibactam
|
19210.0 Nanogram per milliliter
Standard Deviation 18747.86 • Interval 18747.86 to
|
6910.0 Nanogram per milliliter
Standard Deviation 2553.50 • Interval 2553.5 to
|
10570.0 Nanogram per milliliter
Standard Deviation 4342.69 • Interval 4342.69 to
|
PRIMARY outcome
Timeframe: 2 hours and 30 minutes post dose on Day 1Population: PK analysis set for Part A was defined as participants who received a single IV dose of CAZ-AVI in Part A. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Part A: Cohort 1
n=9 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=7 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A
Ceftazidime
|
76822.2 Nanogram per milliliter
Standard Deviation 106423.76 • Interval 106423.76 to
|
32571.4 Nanogram per milliliter
Standard Deviation 10842.00 • Interval 10842.0 to
|
49012.5 Nanogram per milliliter
Standard Deviation 18832.45 • Interval 18832.45 to
|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A
Avibactam
|
13250.0 Nanogram per milliliter
Standard Deviation 16906.67 • Interval 16906.67 to
|
6251.4 Nanogram per milliliter
Standard Deviation 2363.99 • Interval 2363.99 to
|
9788.8 Nanogram per milliliter
Standard Deviation 2956.39 • Interval 2956.39 to
|
PRIMARY outcome
Timeframe: 7 hours post dose on Day 1Population: PK analysis set for Part A was defined as participants who received a single IV dose of CAZ-AVI in Part A.
Outcome measures
| Measure |
Part A: Cohort 1
n=9 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A
Ceftazidime
|
15635.6 Nanogram per milliliter
Standard Deviation 15243.22 • Interval 15243.22 to
|
8305.0 Nanogram per milliliter
Standard Deviation 6728.50 • Interval 6728.5 to
|
17608.8 Nanogram per milliliter
Standard Deviation 8165.42 • Interval 8165.42 to
|
|
Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A
Avibactam
|
2058.2 Nanogram per milliliter
Standard Deviation 1670.32 • Interval 1670.32 to
|
1190.4 Nanogram per milliliter
Standard Deviation 998.69 • Interval 998.69 to
|
3475.6 Nanogram per milliliter
Standard Deviation 1931.10 • Interval 1931.1 to
|
PRIMARY outcome
Timeframe: Day 1 up to maximum of Day 49Population: Safety analysis set for Part B included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part B.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying) ; persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Part A: Cohort 1
n=8 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=5 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B
AEs
|
4 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B
SAEs
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to maximum of Day 49Population: Safety analysis set for Part B included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part B.
Outcome measures
| Measure |
Part A: Cohort 1
n=8 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=5 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants Who Died: Part B
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to maximum of Day 49Population: Safety analysis set for Part B included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part B.
Outcome measures
| Measure |
Part A: Cohort 1
n=8 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=5 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B
Discontinued from study due to AEs
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B
Discontinued study drug due to AE and continue study
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to maximum of Day 49Population: Safety analysis set for Part B included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part B.
Number of participants in Part B with clinically significant abnormal laboratory parameters that occurred in more than 2 participants from Day 1 up to 35 days after the last dose of CAZ-AVI were reported in this outcome measure. Clinically significant labs were abnormal laboratory results which the investigator reported as being clinically significant. Only parameters with non-zero values are reported.
Outcome measures
| Measure |
Part A: Cohort 1
n=8 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=5 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: Blood Ph
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Hematology: Hematocrit
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Hematology: Hemoglobin
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Hematology: Leukocytes
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Hematology: Neutrophils/Leukocytes
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Hematology: Platelets
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry:Alanine Aminotransferase
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: Albumin
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: Aspartate Aminotransferase
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: Base Excess
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: Bilirubin
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: C Reactive Protein
|
2 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: Direct Bilirubin
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry:Partial Pressure Carbon Dioxide
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: Potassium
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
Clinical Chemistry: Procalcitonin
|
0 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of Day 35Population: Safety analysis set for Part A included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part A.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Part A: Cohort 1
n=9 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A
AEs
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A
SAEs
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of Day 35Population: Safety analysis set for Part A included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part A.
Outcome measures
| Measure |
Part A: Cohort 1
n=9 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants Who Died: Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of Day 35Population: Safety analysis set for Part A included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part A.
Outcome measures
| Measure |
Part A: Cohort 1
n=9 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A
Discontinued from study due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A
Discontinued study drug due to AE and continue study
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hours, 2 hours 30 mins, and 7 hours post dose on Day 1Population: PK analysis set for Part B was defined as participants who received at least 3 consecutive doses of CAZ-AVI in Part B. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Part A: Cohort 1
n=8 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=4 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B
Avibactam: 2 hours
|
10340.0 Nanograms per milliliter
Standard Deviation 3262.63 • Interval 3262.63 to
|
11330.0 Nanograms per milliliter
Standard Deviation 2012.53 • Interval 2012.53 to
|
9410.1 Nanograms per milliliter
Standard Deviation 5551.00 • Interval 5551.0 to
|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B
Ceftazidime: 2 hours
|
52950.0 Nanograms per milliliter
Standard Deviation 17565.47 • Interval 17565.47 to
|
48625.0 Nanograms per milliliter
Standard Deviation 17010.46 • Interval 17010.46 to
|
43711.3 Nanograms per milliliter
Standard Deviation 22229.93 • Interval 22229.93 to
|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B
Ceftazidime: 2 hours 30 mins
|
43037.5 Nanograms per milliliter
Standard Deviation 17433.21 • Interval 17433.21 to
|
39000.0 Nanograms per milliliter
Standard Deviation 4415.88 • Interval 4415.88 to
|
42465.0 Nanograms per milliliter
Standard Deviation 26800.19 • Interval 26800.19 to
|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B
Ceftazidime: 7 hours
|
8323.8 Nanograms per milliliter
Standard Deviation 4805.65 • Interval 4805.65 to
|
16735.0 Nanograms per milliliter
Standard Deviation 9070.87 • Interval 9070.87 to
|
18658.4 Nanograms per milliliter
Standard Deviation 18268.92 • Interval 18268.92 to
|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B
Avibactam: 2 hours 30 mins
|
6825.0 Nanograms per milliliter
Standard Deviation 2386.26 • Interval 2386.26 to
|
9380.0 Nanograms per milliliter
Standard Deviation 2317.14 • Interval 2317.14 to
|
9064.0 Nanograms per milliliter
Standard Deviation 5694.05 • Interval 5694.05 to
|
|
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B
Avibactam: 7 hours
|
1025.3 Nanograms per milliliter
Standard Deviation 592.83 • Interval 592.83 to
|
3787.5 Nanograms per milliliter
Standard Deviation 2533.46 • Interval 2533.46 to
|
3890.5 Nanograms per milliliter
Standard Deviation 3867.47 • Interval 3867.47 to
|
SECONDARY outcome
Timeframe: EOIV, EOT, TOC, LFUPopulation: ITT population set included all participants who had been enrolled in each part of the study, regardless of whether or not treatment was received.
Clinical outcome assessed based on clinical cure, improvement, failure, indeterminate. Clinical cure=resolution of acute signs, symptoms.Clinical improvement=participants switched to oral therapy;met following criteria at EOIV:afebrile for 24 hours(H);improvement in at least 1 symptom,sign.Clinical failure=received \>48H of therapy, met any of these:therapy discontinuation due to insufficient effect, AE, death. Indeterminate=data not available for evaluation(death;lost to follow up;diagnosis of CNS infection, osteomyelitis, endocarditis or necrotizing enterocolitis after enrollment). EOIV (Up to 14 days), EOT (Up to 27 days), TOC (Up to 34 days), LFU (Up to 49 days).
Outcome measures
| Measure |
Part A: Cohort 1
n=8 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=5 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOIV: Clinical cure
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOIV: Clinical improvement
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOIV: Clinical failure
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOIV: Indeterminate
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOIV: Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOT: Clinical cure
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOT: Clinical improvement
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOT: Clinical failure
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOT: Indeterminate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
EOT: Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
LFU: Clinical cure
|
8 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
LFU: Clinical improvement
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
LFU: Clinical failure
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
LFU: Indeterminate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
LFU: Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
TOC: Clinical cure
|
7 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
TOC: Clinical improvement
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
TOC: Clinical failure
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
TOC: Indeterminate
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU): Intent to Treat (ITT) Analysis Population: Part B
TOC: Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: EOIV, EOT, TOC, LFUPopulation: Micro ITT population included all participants who had at least 1 gram-negative pathogen in an adequate initial/prestudy culture. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Clinical outcome assessed based on clinical cure, improvement, failure, indeterminate. Clinical cure=resolution of acute signs, symptoms.Clinical improvement=participants switched to oral therapy;met following criteria at EOIV:afebrile for 24 hours(H);improvement in at least 1 symptom,sign.Clinical failure=received \>48H of therapy, met any of these:therapy discontinuation due to insufficient effect, AE, death. Indeterminate=data not available for evaluation(death;lost to follow up;diagnosis of CNS infection, osteomyelitis, endocarditis or necrotizing enterocolitis after enrollment). EOIV (Up to 14 days), EOT (Up to 27 days), TOC (Up to 34 days), LFU (Up to 49 days).
Outcome measures
| Measure |
Part A: Cohort 1
n=7 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=3 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOIV: Clinical cure
|
2 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOIV: Clinical improvement
|
5 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOIV: Clinical failure
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOIV: Indeterminate
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOIV: Missing
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOT: Clinical cure
|
6 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOT: Clinical improvement
|
1 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOT: Clinical failure
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOT: Indeterminate
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
EOT: Missing
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
LFU: Clinical cure
|
7 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
LFU: Clinical improvement
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
LFU: Clinical failure
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
LFU: Indeterminate
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
LFU: Missing
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
TOC: Clinical cure
|
6 Participants
|
—
|
2 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
TOC: Clinical improvement
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
TOC: Clinical failure
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
TOC: Indeterminate
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Micro-ITT Analysis Population: Part B
TOC: Missing
|
0 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: EOIV, EOT, TOC, LFUPopulation: Modified Intent-to-Treat (MITT) population included all participants who received any amount of CAZ-AVI and met minimal disease criteria of infection (defined as the presence of at least 1 clinical criterion and 1 laboratory criterion or met at least 2 clinical criteria in the presence of, or as a result of suspected or proven bacterial infection which required IV antibiotic therapy). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Clinical outcome assessed based on clinical cure, improvement, failure, indeterminate. Clinical cure=resolution of acute signs, symptoms.Clinical improvement=participants switched to oral therapy;met following criteria at EOIV:afebrile for 24 hours(H);improvement in at least 1 symptom,sign.Clinical failure=received \>48H of therapy, met any of these:therapy discontinuation due to insufficient effect, AE, death. Indeterminate=data not available for evaluation(death;lost to follow up;diagnosis of CNS infection, osteomyelitis, endocarditis or necrotizing enterocolitis after enrollment). EOIV (Up to 14 days), EOT (Up to 27 days), TOC (Up to 34 days), LFU (Up to 49 days).
Outcome measures
| Measure |
Part A: Cohort 1
n=8 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=3 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=5 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOIV: Clinical cure
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOIV: Clinical improvement
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOIV: Clinical failure
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOIV: Indeterminate
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOIV: Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOT: Clinical cure
|
6 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOT: Clinical improvement
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOT: Clinical failure
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOT: Indeterminate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
EOT: Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
LFU: Clinical cure
|
8 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
LFU: Clinical improvement
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
LFU: Clinical failure
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
LFU: Indeterminate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
LFU: Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
TOC: Clinical cure
|
7 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
TOC: Clinical improvement
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
TOC: Clinical failure
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
TOC: Indeterminate
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Clinical Outcome At End of IV Treatment(EOIV), End of Treatment(EOT), Test of Cure(TOC) and Late Follow-Up(LFU) in Modified-ITT Analysis Population: Part B
TOC: Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 34 daysPopulation: Micro ITT population included all participants who had at least 1 gram-negative pathogen in an adequate initial/prestudy culture. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Microbiological response was assessed based on eradication, presumed eradication, persistence, presumed persistence, indeterminate. Eradication: source specimen demonstrated absence of the original baseline pathogen. Presumed eradication: source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: source specimen demonstrated continued presence of the original baseline pathogen. Presumed persistence: source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: source specimen was not available to culture and the participant's clinical outcome was assessed as indeterminate.
Outcome measures
| Measure |
Part A: Cohort 1
n=7 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=3 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Enterobacter Cloacae Complex: F: Eradication
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Enterobacter Cloacae Complex: F: Presumed eradication
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Enterobacter Cloacae Complex: U: Persistence
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Enterobacter Cloacae Complex: U: Presumed persistence
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Enterobacter Cloacae Complex Indeterminate
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
E.coli: F: Eradication
|
4 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
E.coli: F: Presumed eradication
|
2 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
E.coli: U: Persistence
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
E.coli:U:Presumed persistence
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
E.coli:Indeterminate
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Oxytoca:F: Eradication
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Oxytoca:F:Presumed eradication
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Oxytoca:U: Persistence
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Oxytoca:U:Presumed persistence
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Oxytoca: Indeterminate
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Pneumoniae:F: Eradication
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Pneumoniae:F:Presumed eradication
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Pneumoniae:U: Persistence
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Pneumoniae:U:Presumed persistence
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B
Klebsiella Pneumoniae: Indeterminate
|
0 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of Day 49Population: Micro ITT population included all participants who had at least 1 gram-negative pathogen in an adequate initial/prestudy culture. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Emergent infections included superinfection and new infection. Superinfection: a culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy requiring alternative antimicrobial therapy. New infection: a culture identified pathogen other than a baseline pathogen at any time after study treatment has finished requiring alternative antimicrobial therapy.
Outcome measures
| Measure |
Part A: Cohort 1
n=7 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=3 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B
Superinfection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B
New infection
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of Day 35Population: Safety analysis set for Part A included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part A.
Number of participants in Part A with clinically significant abnormal laboratory parameters that occurred in more than 2 participants from Day 1 up to 35 days after the last dose of CAZ-AVI were reported in this outcome measure. Clinically significant labs were abnormal laboratory results which the investigator reported as being clinically significant.
Outcome measures
| Measure |
Part A: Cohort 1
n=9 Participants
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 Participants
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 Participants
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A
Hematology: Hematocrit
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A
Hematology: Hemoglobin
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A
Hematology: Leukocytes
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A
Blood chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A
Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part A: Cohort 1
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: Cohort 2
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Cohort 3
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A: Cohort 1
n=9 participants at risk
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 participants at risk
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 participants at risk
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part B: Cohort 1
n=8 participants at risk
On Day 1 participants aged 28days to \<3 months old received a single IV infusion of CAZ-AVI 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 2
n=5 participants at risk
On Day 1 participants aged \>= 37weeks and \<= 28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 3
n=8 participants at risk
On Day 1 participants aged \>=26weeks to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
20.0%
1/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Gastrointestinal disorders
Necrotising colitis
|
11.1%
1/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
20.0%
1/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
20.0%
1/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Infections and infestations
Septic shock
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Investigations
Hepatic enzyme increased
|
11.1%
1/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
20.0%
1/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
20.0%
1/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
Other adverse events
| Measure |
Part A: Cohort 1
n=9 participants at risk
On Day 1 participants aged 28days to less than (\<) 3 months old received a single intravenous (IV) infusion of ceftazidime-avibactam (CAZ-AVI) 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 2
n=8 participants at risk
On Day 1 participants aged greater than or equal to(\>=) 37weeks and less than or equal to (\<=) 28 days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part A: Cohort 3
n=8 participants at risk
On Day 1 participants aged \>=26 week to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period.
|
Part B: Cohort 1
n=8 participants at risk
On Day 1 participants aged 28days to \<3 months old received a single IV infusion of CAZ-AVI 30 milligrams per kilogram (mg/kg) CAZ and 7.5 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 2
n=5 participants at risk
On Day 1 participants aged \>= 37weeks and \<= 28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over 2-hour (+10 min) period every 8 hours (+1 hour).
|
Part B: Cohort 3
n=8 participants at risk
On Day 1 participants aged \>=26weeks to \<37weeks and \<=28days old received a single IV infusion of CAZ-AVI 20 mg/kg CAZ and 5.0 mg/kg AVI over a 2-hour (+10 min) period every 8 hours (+1 hour).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
20.0%
1/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
25.0%
2/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
20.0%
1/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
25.0%
2/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
12.5%
1/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Investigations
Transaminases increased
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
25.0%
2/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/9 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
0.00%
0/5 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
25.0%
2/8 • Part A: Day 1 up to maximum of Day 35; Part B: Day 1 up to maximum of Day 49
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety Analysis Sets for Part A and Part B included participants who received any amount of the investigational drug (CAZ-AVI) in the respective part. The death reported in Part B: cohort 1 occurred after participant completed the study (including safety follow-up).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER