Trial Outcomes & Findings for Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs). (NCT NCT02475733)

NCT ID: NCT02475733

Last Updated: 2018-08-09

Results Overview

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. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 35 days after last dose of study treatment \[IV or oral\]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 83 participants
• Primary outcome timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)
• Results posted on: 2018-08-09

Participant Flow

Participant milestones

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Study STARTED	61	22
Overall Study COMPLETED	59	22
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).

Baseline characteristics by cohort

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.	Total n=83 Participants Total of all reporting groups
Age, Continuous	10.4 years STANDARD_DEVIATION 3.64 • n=5 Participants	9.7 years STANDARD_DEVIATION 3.97 • n=7 Participants	10.2 years STANDARD_DEVIATION 3.71 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	9 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	21 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants	16 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

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. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 35 days after last dose of study treatment [IV or oral]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	8.2 percentage of participants	4.5 percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	52.5 percentage of participants	59.1 percentage of participants

PRIMARY outcome

Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of seizures, diarrhea, renal disorder, and liver disorder relevant to the cephalosporin class within the ST and AEs with preferred term in the system organ class of nervous system disorder system organ class based on MedDRA 20.0) were reported in this outcome measure.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs) AEoSI in the ST of Hypersensitivity/Anaphylaxis	4.9 percentage of participants	13.6 percentage of participants
Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs) AE in the ST of Diarrhea	1.6 percentage of participants	0 percentage of participants
Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs) AE in the ST of Liver Disorder	0 percentage of participants	0 percentage of participants
Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs) AE in the ST of Renal Disorder	0 percentage of participants	0 percentage of participants
Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs) AEs with PTs in the Nervous System Disorder SOC	1.6 percentage of participants	4.5 percentage of participants
Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs) AE of seizure	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit Baseline	102.1 beats per minute Standard Deviation 17.07	103.0 beats per minute Standard Deviation 23.31
Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit Change at EOIV	-15.2 beats per minute Standard Deviation 20.45	-15.4 beats per minute Standard Deviation 21.74

PRIMARY outcome

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit SBP: Baseline	109.7 millimeter of mercury (mmHg) Standard Deviation 13.90	111.6 millimeter of mercury (mmHg) Standard Deviation 13.06
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit SBP: Change at EOIV	-4.0 millimeter of mercury (mmHg) Standard Deviation 12.32	-6.0 millimeter of mercury (mmHg) Standard Deviation 13.66
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit DBP: Baseline	63.5 millimeter of mercury (mmHg) Standard Deviation 10.36	63.1 millimeter of mercury (mmHg) Standard Deviation 13.51
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit DBP: Change at EOIV	1.3 millimeter of mercury (mmHg) Standard Deviation 11.99	-2.8 millimeter of mercury (mmHg) Standard Deviation 14.14

PRIMARY outcome

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Change From Baseline in Respiratory Rate at End of Intravenous Therapy (EOIV) Visit Baseline	22.4 breaths per minute Standard Deviation 5.02	22.9 breaths per minute Standard Deviation 5.79
Change From Baseline in Respiratory Rate at End of Intravenous Therapy (EOIV) Visit Change at EOIV	-1.3 breaths per minute Standard Deviation 4.57	-1.3 breaths per minute Standard Deviation 4.44

PRIMARY outcome

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Change From Baseline in Body Weight at End of Intravenous Therapy (EOIV) Visit Baseline	40.58 kilograms Standard Deviation 16.286	38.35 kilograms Standard Deviation 16.685
Change From Baseline in Body Weight at End of Intravenous Therapy (EOIV) Visit Change at EOIV	-0.38 kilograms Standard Deviation 1.442	-1.06 kilograms Standard Deviation 1.490

PRIMARY outcome

Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Change From Baseline in Body Temperature at End of Intravenous Therapy (EOIV) Visit Change at EOIV	-0.78 degree Celsius Standard Deviation 0.987	-0.60 degree Celsius Standard Deviation 0.780
Change From Baseline in Body Temperature at End of Intravenous Therapy (EOIV) Visit Baseline	37.35 degree Celsius Standard Deviation 1.035	37.16 degree Celsius Standard Deviation 0.914

PRIMARY outcome

Timeframe: EOIV visit (anytime from Day 4 up to 16)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Abdomen	6.6 percentage of participants	18.2 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Cardiovascular System	0 percentage of participants	0 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit General Appearance	1.6 percentage of participants	0 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Head and Neck	0 percentage of participants	0 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Musculoskeletal System	0 percentage of participants	0 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Respiratory System	3.3 percentage of participants	0 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Lymph Nodes	0 percentage of participants	0 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Neurological System	0 percentage of participants	0 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Skin	1.6 percentage of participants	0 percentage of participants
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit Thyroid	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

Criteria for potentially clinically significant laboratory abnormalities: Chemistry (calcium: <0.7*lower limit of normal range [LLN] and >30 percent decrease from baseline [DFB]; alanine aminotransferase [ALT]: >3*upper limit of normal range [ULN] and >300 percent IFB; alanine aminotransferase [AST]: >3*ULN and >300 percent IFB) and hematology (platelets: >2*ULN and >100 percent IFB). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters Chemistry: ALT	1.7 percentage of participants	0 percentage of participants
Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters Chemistry: AST	1.8 percentage of participants	0 percentage of participants
Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters Chemistry: Calcium	1.9 percentage of participants	0 percentage of participants
Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters Hematology: Platelets	3.3 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline until the EOIV visit (anytime from Day 4 to 16)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

ECG parameters included maximum QT intervals using Fridericia's correction (QTcF). Maximum QTcF >450 millisecond (ms); maximum QTcF >480 ms; and maximum QTcF >500 ms. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Electrocardiogram (ECG) Parameter QTcF: > 450, >480 and >500 Millisecond (ms) Maximum QTcF Interval : >500 ms	0 percentage of participants	4.5 percentage of participants
Percentage of Participants With Electrocardiogram (ECG) Parameter QTcF: > 450, >480 and >500 Millisecond (ms) Maximum QTcF Interval : >450 ms	1.6 percentage of participants	4.5 percentage of participants
Percentage of Participants With Electrocardiogram (ECG) Parameter QTcF: > 450, >480 and >500 Millisecond (ms) Maximum QTcF Interval : >480 ms	1.6 percentage of participants	4.5 percentage of participants

PRIMARY outcome

Timeframe: Day 7

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Creatinine Clearance (CrCl) at Day 7 CrCl: >=30 to <50mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Day 7 CrCl: >=80mL/min/1.73 m^2	50.8 percentage of participants	59.1 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Day 7 CrCl: <30mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Day 7 CrCl: >=50 to <80mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: EOIV visit (anytime from Day 4 up to 16)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit CrCl: <30mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit CrCl: >=30 to <50mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit CrCl: >=50 to <80mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit CrCl: >=80mL/min/1.73 m^2	82.0 percentage of participants	81.8 percentage of participants

PRIMARY outcome

Timeframe: TOC visit (up to a maximum study duration of 50 days)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).

CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit CrCl: <30mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit CrCl: >=30 to <50mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit CrCl: >=50 to <80mL/min/1.73 m^2	3.3 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit CrCl: >=80mL/min/1.73 m^2	42.6 percentage of participants	59.1 percentage of participants

PRIMARY outcome

Timeframe: LFU visit (up to a maximum study duration of 50 days)

Population: Safety analysis set included all randomized participants who received any amount of IV study medication.

CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit CrCl: <30mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit CrCl: >=30 to <50mL/min/1.73 m^2	0 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit CrCl: >=50 to <80mL/min/1.73 m^2	1.6 percentage of participants	0 percentage of participants
Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit CrCl: >=80mL/min/1.73 m^2	6.6 percentage of participants	9.1 percentage of participants

SECONDARY outcome

Timeframe: 15, 30-90, 300-360 minutes post-dose on Day 3

Population: PK analysis set included all randomized participants who received any amount of study medication and had at least 1 CAZ and/ or AVI plasma measurement available. This outcome measure was not planned to be analyzed for meropenem receiving cohorts, as pre-specified in protocol.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=60 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Plasma Concentrations of Ceftazidime and Avibactam Ceftazidime: 15 minute post-dose on Day 3	63565.5 nanogram per milliliter Standard Deviation 236761.80	—
Plasma Concentrations of Ceftazidime and Avibactam Ceftazidime: 30-90 minute post-dose on Day 3	38048.0 nanogram per milliliter Standard Deviation 19810.95	—
Plasma Concentrations of Ceftazidime and Avibactam Ceftazidime:300-360minute post-dose on Day 3	4603.0 nanogram per milliliter Standard Deviation 10308.96	—
Plasma Concentrations of Ceftazidime and Avibactam Avibactam: 15 minute post-dose on Day 3	12186.2 nanogram per milliliter Standard Deviation 55720.44	—
Plasma Concentrations of Ceftazidime and Avibactam Avibactam: 30-90 minute post-dose on Day 3	6548.6 nanogram per milliliter Standard Deviation 4437.55	—
Plasma Concentrations of Ceftazidime and Avibactam Avibactam: 300-360 minute post-dose on Day 3	821.5 nanogram per milliliter Standard Deviation 1968.21	—

SECONDARY outcome

Timeframe: End of 72 hours study drug treatment on Day 1

Population: ITT analysis population included all participants who had been assigned a randomized treatment.

Favorable CR was defined as resolution of all acute signs and symptoms of complicated intra- abdominal infection (cIAIs), or improvement to such an extent that no further antimicrobial therapy was required, or improvement but not enough to switch to oral therapy and still on IV study drug at end of 72 hours and had met following criterion: absence of new signs and symptoms, improvement in at least 1 symptom/sign (fever, pain, tenderness, elevated White Blood Cells [WBCs], elevated c-reactive protein) from baseline and no worsening symptom/sign.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Favorable Clinical Response (CR) at End of 72 Hours Treatment: Intent-to-treat (ITT) Analysis Population	93.4 percentage of participants Interval 85.2 to 97.7	90.9 percentage of participants Interval 73.9 to 98.1

SECONDARY outcome

Timeframe: EOIV visit (anytime from Day 4 up to 16)

Population: ITT analysis population included all participants who had been assigned a randomized treatment.

Favorable CR was resolution of all acute signs and symptoms of cIAI or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Favorable Clinical Response (CR) at End of Intravenous Therapy (EOIV) Visit: Intent-to-treat (ITT) Analysis Population	96.7 percentage of participants Interval 89.9 to 99.3	100 percentage of participants Interval 89.3 to 100.0

SECONDARY outcome

Timeframe: EOT visit (up to Day 17)

Population: ITT analysis population included all participants who had been assigned a randomized treatment.

Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Favorable Clinical Response (CR) at End of Treatment (EOT) Visit: Intent-to-treat (ITT) Analysis Population	91.8 percentage of participants Interval 83.0 to 96.8	100 percentage of participants Interval 89.3 to 100.0

SECONDARY outcome

Timeframe: TOC visit (up to a maximum study duration of 50 days)

Population: ITT analysis population included all participants who had been assigned a randomized treatment.

Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Favorable Clinical Response (CR) at Test of Cure (TOC) Visit: Intent-to-treat (ITT) Analysis Population	91.8 percentage of participants Interval 83.0 to 96.8	95.5 percentage of participants Interval 80.7 to 99.5

SECONDARY outcome

Timeframe: End of 72 hours study drug treatment on Day 1, EOIV (anytime from Day 4 up to 16), EOT visit (up to Day 17) and TOC visit (up to a maximum study duration of 50 days)

Population: CE analysis population included randomized participants with cIAI who received study medication for \>=48h and clinical failure or clinical failure with treatment limiting AE and participants with \>=72h treatment and favorable clinicial response.

Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=56 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=20 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population EOIV	98.1 percentage of participants Interval 91.7 to 99.8	100 percentage of participants Interval 88.3 to 100.0
Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population TOC	92.9 percentage of participants Interval 83.9 to 97.5	95.0 percentage of participants Interval 78.9 to 99.5
Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population End 72 hours study medication	98.0 percentage of participants Interval 90.9 to 99.8	95.0 percentage of participants Interval 78.9 to 99.5
Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population EOT	94.2 percentage of participants Interval 85.4 to 98.3	100 percentage of participants Interval 88.3 to 100.0

SECONDARY outcome

Timeframe: EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)

Population: Micro-ITT analysis population included all randomized participants who had a baseline pathogen known to cause cIAI.

Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=50 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=19 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population EOIV	96.0 percentage of participants	100 percentage of participants
Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population EOT	90.0 percentage of participants	100 percentage of participants
Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population TOC	90.0 percentage of participants	94.7 percentage of participants
Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population LFU	90.0 percentage of participants	94.7 percentage of participants

SECONDARY outcome

Timeframe: EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)

Population: ME analysis population included randomized participants with cIAI who received study medication for \>=48h and clinical failure or clinical failure with treatment limiting AE and participants with \>=72h treatment and favorable microbiological response.

Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=40 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=15 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population EOIV	97.5 percentage of participants	100 percentage of participants
Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population EOT	91.7 percentage of participants	100 percentage of participants
Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population TOC	90.0 percentage of participants	93.3 percentage of participants
Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population LFU	89.2 percentage of participants	92.9 percentage of participants

SECONDARY outcome

Timeframe: LFU visit (up to a maximum study duration of 50 days)

Population: CE analysis population included randomized participants with cIAI who received study medication for \>=48h and clinical failure or clinical failure with treatment limiting AE and participants with \>=72h treatment and favorable clinicial response. Here, number of participants analyzed=participants who were evaluable for this measure.

A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=48 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=18 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Population	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: LFU visit (up to a maximum study duration of 50 days)

Population: ME analysis population included randomized participants with cIAI who received study medication for \>=48 h and clinical failure or clinical failure with treatment limiting AE and participants with \>=72 h treatment and favorable microbiological response. Here, number of participants analyzed=participants who were evaluable for this measure.

A participant was said to have clinical relapse if me either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=37 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=14 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Population	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 50 days

Population: Micro-ITT analysis population included all randomized participants who had a baseline pathogen known to cause cIAI.

Emergent infections were categorized as super infections and new infections. Superinfection: An intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: An intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Participants with any (super infections or new infections) of the infections were reported.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=50 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=19 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: TOC visit (up to a maximum study duration of 50 days)

Population: ME analysis population included randomized participants with cIAI who received study medication for \>=48 h and clinical failure or clinical failure with treatment limiting AE and participants with \>=72 h treatment and favorable microbiological response.

Emergent Infections was an intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy, new infection was an intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment has finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). Participants with any (super infections or new infections) of the infections were reported.

Outcome measures

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=40 Participants Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=15 Participants Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Percentage of Participants With Emergent Infections at Test of Cure (TOC) Visit: Microbiologically Evaluable Population	0 percentage of participants	0 percentage of participants

Adverse Events

Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Meropenem

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 participants at risk Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 participants at risk Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Gastrointestinal disorders Ileus	1.6% 1/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.5% 1/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Intestinal obstruction	1.6% 1/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Large intestine perforation	1.6% 1/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Postoperative ileus	1.6% 1/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Renal colic	1.6% 1/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Urethral meatus stenosis	1.6% 1/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Measure	Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole n=61 participants at risk Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.	Meropenem n=22 participants at risk Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Gastrointestinal disorders Abdominal pain	0.00% 0/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 2/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Vomiting	14.8% 9/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 2/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Infusion site phlebitis	6.6% 4/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/61 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.1% 2/22 • Baseline until the LFU visit (up to a maximum study duration of 50 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER