Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection

Complicated Intra-abdominal Infection Clinical Trial

Official title:

A PHASE 3, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (PF-06947386) PLUS METRONIDAZOLE IN JAPANESE ADULT PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTION REQUIRING HOSPITALIZATION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927312
• Other study ID #: C3591036
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study C3591036 is a Phase 3 study to assess the efficacy and safety of PF-06947386 in Japanese adult patients with complicated intra-abdominal infection requiring hospitalization. This is a multicenter, open-label, single-arm study. All eligible participants will receive intravenous infusion of PF-06947386 followed by intravenous infusion of metronidazole.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Participant who is capable of giving signed, dated and timed informed consent (or by their legally acceptable representative)

• Participant aged 20 years or older

• Participant who is willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

• Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections

• Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis

Exclusion Criteria:

• Participant will undergo surgery for traumatic bowel perforation within 12 hours or perforation of gastroduodenal ulcers within 24 hours. Other intra-abdominal processes that are not infectious.

• Participant has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation

• Participant whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization.

• Participant has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for >24 hours

• Participant has suspected intra-abdominal infections due to fungus, parasites (eg, amebic liver abscess), virus, or tuberculosis

• Participant is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness

• Participant is pregnant or breastfeeding.

• Participant has received systemic antibacterial agents within the 72-hour period prior to study entry except for cases specified in the protocol such that participant is considered to have failed the previous treatment regimen, or participant has received systemic antibiotic agents no more than 24 hours (no more than one daily dose) within the 72-hour period prior to study entry, etc.

• Estimated CrCL =50 mL/min calculated by Cockcroft-Gault method.

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Intra-abdominal Infection
• Infections
• Intraabdominal Infections

Intervention

Drug:
• PF-06947386
Ceftazidime-Avibactam powder for concentrate for solution for infusion 2.0 g/ 0.5 g. Dosage will be adjusted based on renal function after enrollment.
• Metronidazole
Metronidazole 0.5 g solution for injection.

Locations

Country	Name	City	State
Japan	National Hospital Organization Chiba Medical Center	Chiba
Japan	Fukuoka Wajiro Hospital	Fukuoka
Japan	Rinku General Medical Center	Izumisano	Osaka
Japan	National Hospital Organization Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	Fukuoka Tokushukai Hospital	Kasuga	Fukuoka
Japan	National Hospital Organization Osaka Minami Medical Center	Kawachinagano	Osaka
Japan	Kawasaki Saiwai Hospital	Kawasaki-shi	Kanagawa
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	St.Mary's Hospital	Kurume	Fukuoka
Japan	National Hospital Organization Kyoto Medical Center	Kyoto
Japan	Gunma Saiseikai Maebashi Hospital	Maebashi	Gunma
Japan	Saiseikai Maebashi Hospital	Maebashi	Gunma
Japan	Nagaoka Chuo General Hospital	Nagaoka	Niigata
Japan	Nagoya Ekisaikai Hospital	Nagoya	Aichi
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	Naha City Hospital	Naha	Okinawa
Japan	Okayama City General Medical Center Okayama City Hospital	Okayama
Japan	National Hospital Organization Nagasaki Medical Center	Omura	Nagasaki
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka
Japan	Sagamihara Kyodo Hospital	Sagamihara	Kanagawa
Japan	Teine Keijinkai Hospital	Sapporo	Hokkaido
Japan	Suwa Red Cross Hospital	Suwa	Nagano
Japan	Toyama University Hospital	Toyama
Japan	National Hospital Organization Toyohashi Medical Center	Toyohashi	Aichi
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura	Ibaraki
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura-shi	Ibaraki
Japan	Yamagata City Hospital Saiseikan	Yamagata
Japan	National Hospital Organization Yokohama Medical Center	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Clinical Response at TOC Visit: MITT Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	TOC: Any day from Day 28 to Day 35
Other	Number of Participants With Clinical Response at TOC Visit: mMITT Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	TOC: Any day from Day 28 to Day 35
Other	Number of Participants With Clinical Response at TOC: ME Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	TOC: Any day from Day 28 to Day 35
Other	Number of Participants With Clinical Response at TOC: eME Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	TOC: Any day from Day 28 to Day 35
Other	Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset	Clinical response of cure was defined as complete resolution or significant improvement of signs & symptoms of index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from day of 1st IV infusion, allowed visit window was 28¬-35 calendar days after day of 1st IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptom of intra-abdominal infection; Indeterminate:Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU:after 42 calendar days from day of 1st IV infusion, allowed visit window was 42-49 calendar days from 1st IV infusion. TOC:after 28 calendar days from 1st IV infusion, allowed visit window was 28-35 calendar days after 1st IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Other	Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset	Clinical response of cure was defined as complete resolution or significant improvement of signs & symptoms of index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from day of 1st IV infusion, allowed visit window was 28¬-35 calendar days after day of 1st IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptom of intra-abdominal infection; Indeterminate:Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU:after 42 calendar days from day of 1st IV infusion, allowed visit window was 42-49 calendar days from 1st IV infusion. TOC:after 28 calendar days from 1st IV infusion, allowed visit window was 28-35 calendar days after 1st IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Other	Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Other	Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Other	Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Other	Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Other	Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Other	Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Other	Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Participants Subset	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.	Up to Day 49
Other	Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Evaluable Participants Subset	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.	Up to Day 49
Primary	Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	TOC: Any day from Day 28 to Day 35
Secondary	Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.	EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Secondary	Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.	EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Secondary	Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.	EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.	EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set	Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.	EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Secondary	Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set	Microbiological response: Favorable microbiological response assessments include "eradication", "presumed eradication" and "colonization". Unfavorable microbiological response assessments include "persistence", "persistence with increasing MIC", and "presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. "Indeterminate" were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.	EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.	Up to Day 49
Secondary	All-cause Mortality	Number of participants with death is presented.	Up to Day 49
Secondary	Number of Participants Who Discontinued Treatment and Study Due to Adverse Events	Number of participants who discontinued treatment and study due to adverse events is presented.	Up to Day 49
Secondary	Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	A semiautomated recording device was used to measure SBP and DBP with participant in a supine position after at least 5 minutes of rest.	Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate	Pulse rate was measured for in a supine position preceded by at least 5 minutes of rest for the participant.	Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight	Body weight was measured using a balance scale.	Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature	Temperature was measured in a supine position, after the participant had rest for at least 5 minutes.	Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate	Respiratory rate was measured in a supine position, after the participant had rest for at least 5 minutes.	Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Secondary	Number of Participants With Laboratory Test Abnormalities	Criteria for abnormal laboratory values for chemistry parameters: Bilirubin >1.5*upper limit of normal (ULN), direct Bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, total protein and albumin <0.8*lower limit of normal (LLN), urea nitrogen and creatinine >1.3*ULN, sodium >0.95*LLN, potassium >0.9*LLN and >1.1*ULN, calcium >0.9*LLN, glucose > 1.5*LLN; hematology parameters: Hemoglobin, hematocrit, erythrocytes <0.8*LLN, platelets <0.5*LLN and > 1.75*ULN, leukocytes <0.6*LLN and <0.6*LLN, lymphocytes <0.8* LLN, lymphocytes/leukocytes <0.8* LLN and >1.2*ULN, neutrophils >1.2*ULN, neutrophils/leukocytes <0.8*LLN and >1.2* ULN, basophils/leukocytes >1.2*ULN, eosinophils >1.2*ULN, eosinophils/leukocytes >1.2*ULN, monocytes and monocytes/leukocytes >1.2*ULN; Criteria for abnormal laboratory values for urinalysis parameters: urine glucose, >=1, urine protein >=1, urine Hemoglobin>=1.	Up to Day 49
Secondary	Plasma Concentration of Avibactam	Plasma concentrations of avibactam was measured by nominal sampling window.	Day 3, Day 4, and Combination of Day 3 and 4: 15 minutes before or after infusion, 30-90 minutes after infusion, 300-360 minutes after infusion
Secondary	Plasma Concentration of Ceftazidime	Plasma concentrations of ceftazidime was measured by nominal sampling window.	Day 3, Day 4, and Combination of Day 3 and 4: 15 minutes before or after infusion, 30-90 minutes after infusion, 300-360 minutes after infusion

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