Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.

A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 3 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04126031

Acronym

NOOR

Enrollment

Registered

2019-10-14

Start date

2020-01-14

Completion date

2022-12-30

Last updated

2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gram-negative Bacterial Infection

Keywords

Gram-negative, ceftazidime-avibactam, neonate, infant

Brief summary

This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.

Detailed description

This is a 2-part, Phase 2a, non-randomized, open-label multicenter, multinational study of intravenous ceftazidime-avibactam in hospitalized neonates and infants with suspected or confirmed bacterial infection. In Part A of the study, patients already receiving intravenous antibacterial therapy with another antibiotic will receive a single intravenous dose of ceftazidime-avibactam followed by observation for 48 hours and a Late Follow-Up assessment 4-5 weeks later. In Part B of the study, patients with suspected or confirmed Gram-negative bacterial infections requiring intravenous antibacterial therapy will receive multiple doses of intravenous ceftazidime-avibactam for up to 14 days. At the discretion of the investigator, patients may also receive other antibiotics if the infection is suspected to include Gram-positive bacteria, multi-drug resistant Gram-negative bacteria, or anaerobic bacteria. At the discretion of the investigator, patients may be switched to oral therapy or outpatient parenteral antimicrobial therapy with an alternative antibiotic after receiving intravenous ceftazidime-avibactam for at least 48 yhours. Clinical outcomes will be assessed at the End of Intravenous (EOIV) treatment with ceftazidime-avibactam, the End-of-Therapy (EOT), the Test-of-Cure (TOC) at 7-14 days after the last study therapy and at a Late Follow-Up (LFU) visit, 28-55 days after the last dose of ceftazidime-avibactam. Safety assessments will occur throughout the study. Ceftazidime-avibactam blood levels will be assessed during the first 12 hours after the single dose of ceftazidime-avibactam in Part A and during 12 hours after at least 3 consecutive doses of ceftazidime-avibactam in Part B.

Interventions

DRUGPart A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3

Single intravenous infusion of ceftazidime-avibactam over 2 hours

DRUGPart B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3

Multiple intravenous infusions of ceftazidime-avibactam over 2 hours, repeated every 8 hours up to 14 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Non-randomized, 2-part with three age cohorts in each part

Eligibility

Sex/Gender

ALL

Age

0 Days to 88 Days

Healthy volunteers

Inclusion criteria

(All Subjects): 1. Evidence of a personally signed and dated informed consent document indicating that the subject's parent(s), legal guardian, or legally acceptable representative has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Male or female neonates and infants with age at Screening: Cohort 1: Full term infants (gestational age ≥ 37 weeks) with chronological age \>28 days to \<3 months (\<89 days) or pre-term infants with corrected age \>28 days to \<3 months (\<89 days). A maximum of 3 pre-term corrected age infants may be enrolled in each part (A and B) of Cohort 1. Sites will be notified in writing if this limit is reached. Cohort 2: Full term neonates (gestational age ≥ 37 weeks) from birth to ≤ 28 days. Cohort 3: Pre-term neonates (gestational age ≥ 26 to \<37 weeks) from birth to ≤ 28 days. Corrected age = Subtract the number of weeks born before 40 weeks of gestation from the chronological age. Inclusion Criteria for Part A Subjects Only: 1\. Hospitalized and receiving intravenous antibacterial therapy for the treatment of a suspected or confirmed bacterial infection. Inclusion Criteria for Part B Subjects Only: 1. Hospitalized with suspected or confirmed aerobic Gram-negative bacterial infection requiring intravenous antibacterial therapy. 2. Subjects must meet at least 1 clinical and 1 laboratory criterion or meet at least 2 of the clinical criteria: Clinical Criteria: 1. Hypothermia (\<36ºC) OR fever (\>38.5ºC); 2. Bradycardia OR tachycardia OR rhythm instability; 3. Urine output 0.5 to 1 mL/kg/h OR hypotension OR mottled skin OR impaired peripheral perfusion; 4. Petechial rash OR sclerema neonatorum; 5. New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support; 6. Feeding intolerance OR poor suckling OR abdominal distension; 7. Irritability; 8. Lethargy; 9. Hypotonia. Laboratory Criteria: 1. White blood cell count ≤ 4.0 × 10\^9/L OR ≥ 20.0 × 10\^9/L; 2. Immature to total neutrophil ratio \>0.2; 3. Platelet count ≤ 100 × 10\^9/L; 4. C reactive protein (CRP) \>15 mg/L OR procalcitonin ≥ 2 ng/mL; 5. Hyperglycemia OR Hypoglycemia; 6. Metabolic acidosis.

Exclusion criteria

(All Subjects): 1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study. 2. Participation in another clinical study involving investigational drug(s) within 30 days prior to study entry and/or during this study participation or have previously participated in the current study or in another study of CAZ-AVI (in which an active agent was received). 3. Use of potent inhibitors of organic anion transporters OAT1 and/or OAT3 (eg, probenecid, p-aminohippuric acid (PAH), or teriflunomide) are prohibited. This prohibition of OAT1 and/or OAT3 inhibitors also applies to the mothers of any neonates or infants who are breast feeding during the trial. 4. Other acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study. 5. Documented history of any hypersensitivity or allergic reaction to any beta-lactam antibiotic. 6. Refractory septic shock within 24 hours before screening that does not resolve after 60 minutes of vasopressor therapy. 7. Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (ULN) for age OR urine output \<0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis. Deterioration of renal function after enrollment during Part B of the study will be handled on a case-by-case basis in discussion with the Medical Monitor. 8. Evidence of progressively fatal underlying disease, or life expectancy of ≤ 60 days. 9. Documented history of seizure. 10. Active acute viral hepatitis or acute hepatic failure. 11. Known Clostridium difficile associated diarrhea. 12. Requiring or currently taking antiretroviral therapy for human immunodeficiency virus (HIV) or known HIV positive mother. 13. Any condition (eg, cystic fibrosis, urea cycle disorders), antepartum/peripartum factors, or procedures that would, in the opinion of the Investigator, make the subject unsuitable for the study, place a subject at risk, or compromise the quality of data. 14. Treatment with ceftazidime within 12 hours of CAZ-AVI administration.

Design outcomes

Primary

Measure	Time frame	Description
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A	2 hours post dose on Day 1	—
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A	2 hours and 30 minutes post dose on Day 1	—
Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A	7 hours post dose on Day 1	—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B	Day 1 up to maximum of Day 49	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.
Number of Participants Who Died: Part B	Day 1 up to maximum of Day 49	—
Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B	Day 1 up to maximum of Day 49	—
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Day 1 up to maximum of Day 49	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.

Secondary

Measure	Time frame	Description
Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Up to 34 days	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.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A	Day 1 up to maximum of Day 35	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.
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Day 1 up to maximum of Day 35	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.
Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B	Day 1 up to maximum of Day 49	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.
Number of Participants Who Died: Part A	Day 1 up to maximum of Day 35	—
Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A	Day 1 up to maximum of Day 35	—
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B	2 hours, 2 hours 30 mins, and 7 hours post dose on Day 1	—
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, EOT, TOC, LFU	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).
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, EOT, TOC, LFU	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).
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, EOT, TOC, LFU	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).

Countries

Estonia, Greece, Hungary, India, Italy, Slovakia, Taiwan, United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	9
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.	8
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.	8
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).	8
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).	5
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).	8
Total	46

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG004	FG005
Part A	Other	1	0	0	0
Part A	Withdrawal by Subject	0	1	0	0
Part B	Adverse Event	0	0	0	2
Part B	Pre-existing hypertransaminasemia	0	0	1	0

Baseline characteristics

Characteristic	Part A: Cohort 1	Part A: Cohort 2	Part A: Cohort 3	Part B: Cohort 1	Part B: Cohort 2	Part B: Cohort 3	Total
Age, Continuous	59.0 Days STANDARD_DEVIATION 15.73	19.3 Days STANDARD_DEVIATION 9	14.6 Days STANDARD_DEVIATION 7.46	51.1 Days STANDARD_DEVIATION 18.16	15.80 Days STANDARD_DEVIATION 7.63	17.8 Days STANDARD_DEVIATION 8.99	31.13 Days STANDARD_DEVIATION 22.19
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants	7 Participants	7 Participants	8 Participants	5 Participants	8 Participants	42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	00 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	5 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	4 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	6 Participants	5 Participants	7 Participants	5 Participants	5 Participants	8 Participants	36 Participants
Sex: Female, Male Female	5 Participants	4 Participants	6 Participants	3 Participants	1 Participants	6 Participants	25 Participants
Sex: Female, Male Male	4 Participants	4 Participants	2 Participants	5 Participants	4 Participants	2 Participants	21 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 9	0 / 8	0 / 8	0 / 8	0 / 5	1 / 8
other Total, other adverse events	1 / 9	0 / 8	1 / 8	3 / 8	1 / 5	4 / 8
serious Total, serious adverse events	2 / 9	0 / 8	1 / 8	1 / 8	2 / 5	2 / 8

Outcome results

Primary

Number of Participants Who Died: Part B

Time frame: Day 1 up to maximum of Day 49

Population: Safety analysis set for Part B included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part B.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants Who Died: Part B	0 Participants
Part A: Cohort 2	Number of Participants Who Died: Part B	0 Participants
Part A: Cohort 3	Number of Participants Who Died: Part B	1 Participants

Primary

Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B

Time frame: Day 1 up to maximum of Day 49

Population: Safety analysis set for Part B included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part B.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B	Discontinued from study due to AEs	0 Participants
Part A: Cohort 1	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B	Discontinued study drug due to AE and continue study	0 Participants
Part A: Cohort 2	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B	Discontinued from study due to AEs	0 Participants
Part A: Cohort 2	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B	Discontinued study drug due to AE and continue study	0 Participants
Part A: Cohort 3	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B	Discontinued from study due to AEs	2 Participants
Part A: Cohort 3	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B	Discontinued study drug due to AE and continue study	0 Participants

Primary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): 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.

Time frame: Day 1 up to maximum of Day 49

Population: Safety analysis set for Part B included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part B.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B	AEs	4 Participants
Part A: Cohort 1	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B	SAEs	1 Participants
Part A: Cohort 2	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B	AEs	4 Participants
Part A: Cohort 2	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B	SAEs	2 Participants
Part A: Cohort 3	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B	AEs	7 Participants
Part A: Cohort 3	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B	SAEs	2 Participants

Primary

Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: 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.

Time frame: Day 1 up to maximum of Day 49

Population: Safety analysis set for Part B included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part B.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: C Reactive Protein	2 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Blood Ph	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Albumin	1 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Hematocrit	2 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Bilirubin	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Aspartate Aminotransferase	1 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Potassium	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Base Excess	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Leukocytes	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Procalcitonin	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry:Partial Pressure Carbon Dioxide	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Neutrophils/Leukocytes	1 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry:Alanine Aminotransferase	1 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Direct Bilirubin	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Platelets	1 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Hemoglobin	2 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Neutrophils/Leukocytes	2 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry:Alanine Aminotransferase	1 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Hematocrit	0 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Hemoglobin	0 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Leukocytes	2 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Platelets	1 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Albumin	2 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Aspartate Aminotransferase	2 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Base Excess	3 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Bilirubin	1 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Blood Ph	3 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: C Reactive Protein	4 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Direct Bilirubin	1 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry:Partial Pressure Carbon Dioxide	1 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Potassium	2 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Procalcitonin	2 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Blood Ph	3 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Platelets	2 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Procalcitonin	4 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: C Reactive Protein	8 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Neutrophils/Leukocytes	0 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Potassium	1 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Direct Bilirubin	3 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Leukocytes	1 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Aspartate Aminotransferase	1 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Hematocrit	1 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Base Excess	3 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Albumin	2 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry:Partial Pressure Carbon Dioxide	2 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry: Bilirubin	2 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Clinical Chemistry:Alanine Aminotransferase	1 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B	Hematology: Hemoglobin	2 Participants

Primary

Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A

Time frame: 2 hours and 30 minutes post dose on Day 1

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 2	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A	Ceftazidime	32571.4 Nanogram per milliliter	Standard Deviation 10842
Part A: Cohort 2	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A	Avibactam	6251.4 Nanogram per milliliter	Standard Deviation 2363.99
Part A: Cohort 3	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A	Ceftazidime	49012.5 Nanogram per milliliter	Standard Deviation 18832.45
Part A: Cohort 3	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A	Avibactam	9788.8 Nanogram per milliliter	Standard Deviation 2956.39

Primary

Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A

Time frame: 2 hours post dose on Day 1

Population: The Pharmacokinetic (PK) analysis set for Part A was defined as participants who received a single IV dose of CAZ-AVI in Part A.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: Cohort 1	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A	Ceftazidime	104544.4 Nanogram per milliliter	Standard Deviation 113161.34
Part A: Cohort 1	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A	Avibactam	19210.0 Nanogram per milliliter	Standard Deviation 18747.86
Part A: Cohort 2	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A	Ceftazidime	35537.5 Nanogram per milliliter	Standard Deviation 13473.88
Part A: Cohort 2	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A	Avibactam	6910.0 Nanogram per milliliter	Standard Deviation 2553.5
Part A: Cohort 3	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A	Ceftazidime	53212.5 Nanogram per milliliter	Standard Deviation 25972.32
Part A: Cohort 3	Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A	Avibactam	10570.0 Nanogram per milliliter	Standard Deviation 4342.69

Primary

Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A

Time frame: 7 hours post dose on Day 1

Population: PK analysis set for Part A was defined as participants who received a single IV dose of CAZ-AVI in Part A.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: Cohort 1	Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A	Ceftazidime	15635.6 Nanogram per milliliter	Standard Deviation 15243.22
Part A: Cohort 1	Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A	Avibactam	2058.2 Nanogram per milliliter	Standard Deviation 1670.32
Part A: Cohort 2	Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A	Ceftazidime	8305.0 Nanogram per milliliter	Standard Deviation 6728.5
Part A: Cohort 2	Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A	Avibactam	1190.4 Nanogram per milliliter	Standard Deviation 998.69
Part A: Cohort 3	Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A	Ceftazidime	17608.8 Nanogram per milliliter	Standard Deviation 8165.42
Part A: Cohort 3	Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A	Avibactam	3475.6 Nanogram per milliliter	Standard Deviation 1931.1

Secondary

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

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).

Time frame: EOIV, EOT, TOC, LFU

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 3	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
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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	0 Participants
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	0 Participants
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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
Part A: Cohort 3	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	2 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants

Secondary

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

Time frame: EOIV, EOT, TOC, LFU

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 2	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
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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	2 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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
Part A: Cohort 2	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	2 Participants
Part A: Cohort 2	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	4 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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	0 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	3 Participants
Part A: Cohort 3	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	3 Participants
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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	0 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	3 Participants
Part A: Cohort 3	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	1 Participants

Secondary

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

Time frame: EOIV, EOT, TOC, LFU

Population: ITT population set included all participants who had been enrolled in each part of the study, regardless of whether or not treatment was received.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 2	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
Part A: Cohort 2	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
Part A: Cohort 2	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	2 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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	3 Participants
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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	4 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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
Part A: Cohort 2	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	1 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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	3 Participants
Part A: Cohort 2	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
Part A: Cohort 2	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
Part A: Cohort 2	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	2 Participants
Part A: Cohort 2	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
Part A: Cohort 3	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	3 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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	3 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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
Part A: Cohort 3	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	6 Participants
Part A: Cohort 3	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	1 Participants
Part A: Cohort 3	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
Part A: Cohort 3	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
Part A: Cohort 3	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	3 Participants
Part A: Cohort 3	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	3 Participants
Part A: Cohort 3	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	1 Participants

Secondary

Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B

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.

Time frame: Up to 34 days

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex: F: Presumed eradication	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex: U: Persistence	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae:U: Persistence	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex: F: Eradication	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex: U: Presumed persistence	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex Indeterminate	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli: F: Eradication	4 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli: F: Presumed eradication	2 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli: U: Persistence	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli:U:Presumed persistence	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli:Indeterminate	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca:F: Eradication	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca:F:Presumed eradication	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca:U: Persistence	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca:U:Presumed persistence	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca: Indeterminate	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae:F: Eradication	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae:F:Presumed eradication	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae:U:Presumed persistence	0 Participants
Part A: Cohort 1	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae: Indeterminate	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae:U:Presumed persistence	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex: F: Presumed eradication	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca:U:Presumed persistence	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex: U: Persistence	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli:U:Presumed persistence	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca: Indeterminate	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli:Indeterminate	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae:F:Presumed eradication	1 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex: F: Eradication	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca:F: Eradication	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex: U: Presumed persistence	1 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae: Indeterminate	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Enterobacter Cloacae Complex Indeterminate	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca:F:Presumed eradication	1 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli: F: Eradication	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae:F: Eradication	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli: F: Presumed eradication	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Oxytoca:U: Persistence	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	E.coli: U: Persistence	0 Participants
Part A: Cohort 3	Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B	Klebsiella Pneumoniae:U: Persistence	0 Participants

Secondary

Number of Participants Who Died: Part A

Time frame: Day 1 up to maximum of Day 35

Population: Safety analysis set for Part A included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part A.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants Who Died: Part A	0 Participants
Part A: Cohort 2	Number of Participants Who Died: Part A	0 Participants
Part A: Cohort 3	Number of Participants Who Died: Part A	0 Participants

Secondary

Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A

Time frame: Day 1 up to maximum of Day 35

Population: Safety analysis set for Part A included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part A.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A	Discontinued study drug due to AE and continue study	0 Participants
Part A: Cohort 1	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A	Discontinued from study due to AEs	0 Participants
Part A: Cohort 2	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A	Discontinued study drug due to AE and continue study	0 Participants
Part A: Cohort 2	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A	Discontinued from study due to AEs	0 Participants
Part A: Cohort 3	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A	Discontinued from study due to AEs	0 Participants
Part A: Cohort 3	Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A	Discontinued study drug due to AE and continue study	0 Participants

Secondary

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): 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.

Time frame: Day 1 up to maximum of Day 35

Population: Safety analysis set for Part A included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part A.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A	AEs	4 Participants
Part A: Cohort 1	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A	SAEs	2 Participants
Part A: Cohort 2	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A	AEs	2 Participants
Part A: Cohort 2	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A	SAEs	0 Participants
Part A: Cohort 3	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A	AEs	2 Participants
Part A: Cohort 3	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A	SAEs	1 Participants

Secondary

Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: 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.

Time frame: Day 1 up to maximum of Day 35

Population: Safety analysis set for Part A included all participants who received any amount of the investigational drug (CAZ-AVI) in the Part A.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Hematocrit	1 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Blood chemistry	0 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Leukocytes	1 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Hemoglobin	1 Participants
Part A: Cohort 1	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Urinalysis	0 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Leukocytes	2 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Urinalysis	0 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Hemoglobin	1 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Hematocrit	1 Participants
Part A: Cohort 2	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Blood chemistry	0 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Urinalysis	0 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Hemoglobin	2 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Leukocytes	3 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Hematology: Hematocrit	2 Participants
Part A: Cohort 3	Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A	Blood chemistry	0 Participants

Secondary

Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B

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.

Time frame: Day 1 up to maximum of Day 49

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: Cohort 1	Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B	Superinfection	0 Participants
Part A: Cohort 1	Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B	New infection	0 Participants
Part A: Cohort 2	Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B	Superinfection	0 Participants
Part A: Cohort 2	Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B	New infection	0 Participants
Part A: Cohort 3	Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B	Superinfection	0 Participants
Part A: Cohort 3	Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B	New infection	0 Participants

Secondary

Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B

Time frame: 2 hours, 2 hours 30 mins, and 7 hours post dose on Day 1

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 1	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
Part A: Cohort 2	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	3787.5 Nanograms per milliliter	Standard Deviation 2533.46
Part A: Cohort 2	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	48625.0 Nanograms per milliliter	Standard Deviation 17010.46
Part A: Cohort 2	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	11330.0 Nanograms per milliliter	Standard Deviation 2012.53
Part A: Cohort 2	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	9380.0 Nanograms per milliliter	Standard Deviation 2317.14
Part A: Cohort 2	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	39000.0 Nanograms per milliliter	Standard Deviation 4415.88
Part A: Cohort 2	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	16735.0 Nanograms per milliliter	Standard Deviation 9070.87
Part A: Cohort 3	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	42465.0 Nanograms per milliliter	Standard Deviation 26800.19
Part A: Cohort 3	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	18658.4 Nanograms per milliliter	Standard Deviation 18268.92
Part A: Cohort 3	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	3890.5 Nanograms per milliliter	Standard Deviation 3867.47
Part A: Cohort 3	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	9410.1 Nanograms per milliliter	Standard Deviation 5551
Part A: Cohort 3	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	43711.3 Nanograms per milliliter	Standard Deviation 22229.93
Part A: Cohort 3	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	9064.0 Nanograms per milliliter	Standard Deviation 5694.05

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026

Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.

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Primary

Secondary

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Outcome results

Number of Participants Who Died: Part B

Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B

Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B

Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A

Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A

Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A

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

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

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

Number of Participants According to Microbiological Response at TOC Visit in Micro-ITT Population: Part B

Number of Participants Who Died: Part A

Number of Participants Who Discontinued Treatment and Study Due to AEs: Part A

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs): Part A

Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part A

Number of Participants With Emergent Infections in Micro-ITT Analysis Population: Part B

Plasma Concentrations of Ceftazidime and Avibactam 2 Hours, 2 Hours and 30 Minutes, 7 Hours Post Doses on Day 1: Part B