Page last updated: 2024-10-31

metronidazole and Intra-Abdominal Infections

metronidazole has been researched along with Intra-Abdominal Infections in 48 studies

Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.
metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death.

Research Excerpts

Excerpt	Relevance	Reference
"Metronidazole is frequently used off-label in infants with complicated intra-abdominal infections (cIAI) to provide coverage against anaerobic organisms, but its safety and efficacy in this indication are unknown."	9.34	Safety of Metronidazole in Late Pre-term and Term Infants with Complicated Intra-abdominal Infections. ( Benjamin, D; Bumpass, TG; Cohen-Wolkowiez, M; Commander, SJ; Courtney, SE; Debski, J; Delmore, P; Erinjeri, J; Gao, J; Heresi, G; Hornik, CP; Lavery, AP; Moya, F; Sharma, G; Smith, PB; Sokol, GM; Tracy, ET; Zinkhan, EK, 2020)
" The characteristics and outcomes of patients infected with ESBL-ENT were examined in a pooled analysis of Phase 3 clinical trials of ceftolozane/tazobactam in patients with complicated urinary tract infections (ASPECT-cUTI) and complicated intra-abdominal infections (ASPECT-cIAI)."	9.24	Efficacy of ceftolozane/tazobactam against urinary tract and intra-abdominal infections caused by ESBL-producing Escherichia coli and Klebsiella pneumoniae: a pooled analysis of Phase 3 clinical trials. ( Bliss, CA; Cloutier, D; Hershberger, E; Huntington, JA; Kaye, KS; Miller, B; Paterson, DL; Popejoy, MW; Steenbergen, JN; Umeh, O, 2017)
"Ceftolozane-tazobactam is active against Gram-negative pathogens, including multidrug-resistant Pseudomonas aeruginosa In a subgroup analysis of patients with complicated intra-abdominal infections (cIAIs) involving P."	9.22	Characteristics and Outcomes of Complicated Intra-abdominal Infections Involving Pseudomonas aeruginosa from a Randomized, Double-Blind, Phase 3 Ceftolozane-Tazobactam Study. ( Alverdy, J; Hershberger, E; Miller, B; Popejoy, MW; Steenbergen, JN, 2016)
"ASPECT-cIAI (Assessment of the Safety Profile and Efficacy of Ceftolozane/Tazobactam in Complicated Intra-abdominal Infections) was a prospective, randomized, double-blind trial."	9.20	Ceftolozane/Tazobactam Plus Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results From a Randomized, Double-Blind, Phase 3 Trial (ASPECT-cIAI). ( Barie, PS; Collins, S; Eckmann, C; Friedland, I; Hershberger, E; Miller, B; Popejoy, M; Solomkin, J; Steenbergen, J; Yoon, M; Yuan, G, 2015)
"Ceftolozane-tazobactam (TOL-TAZ) is a novel antibacterial with activity against Pseudomonas aeruginosa and other common Gram-negative pathogens, including extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, that are associated with complicated intra-abdominal infections (cIAIs)."	9.19	Multicenter, double-blind, randomized, phase II trial to assess the safety and efficacy of ceftolozane-tazobactam plus metronidazole compared with meropenem in adult patients with complicated intra-abdominal infections. ( Friedland, I; Hershberger, E; Lucasti, C; Miller, B; Solomkin, J; Steenbergen, J; Yankelev, S, 2014)
"Avibactam, a novel non-β-lactam β-lactamase inhibitor, restores the in vitro activity of ceftazidime against class A, C and some class D β-lactamase-producing pathogens, including those commonly associated with complicated intra-abdominal infections (cIAIs)."	9.17	Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, Phase II trial. ( Lipka, J; Lucasti, C; Popescu, I; Ramesh, MK; Sable, C, 2013)
"This randomized, open-label, multi-center trial compared tigecycline (TGC), a broad-spectrum glycylcycline, with ceftriaxone-metronidazole (CTX/MET) for the treatment of complicated intra-abdominal infections (cIAI)."	9.16	Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. ( Babinchak, T; Leister-Tebbe, H; McGovern, PC; Pedersen, R; Qvist, N; Warren, B; Zito, ET, 2012)
"With the increase in drug resistance rates of pathogens isolated from complicated intra-abdominal infections (cIAIs), ceftazidime/avibactam (CAZ-AVI) is increasingly used clinically."	8.31	Cost-effectiveness of ceftazidime/avibactam plus metronidazole versus meropenem as first-line empiric therapy for the treatment of complicated intra-abdominal infections: A study based on the in-vitro surveillance data in China. ( Fu, J; Li, X; Lv, Q; Shi, X; Wan, X; Xu, Q, 2023)
" Secondary endpoints included clinical and microbiologic responses at the TOC and end-of-treatment (≤24 hours after last dose) visits and adverse event rates."	7.11	A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections. ( Bensaci, M; Bruno, CJ; Chen, G; Chen, X; Du, X; Fan, J; Huntington, JA; Johnson, MG; Sun, F; Sun, Y; Wang, H; Wang, Y, 2022)
"gov Identifier: NCT02739997) to investigate the efficacy and safety of tazobactam/ceftolozane used in combination with metronidazole in Japanese patients with cIAI was conducted."	6.90	The efficacy and safety of tazobactam/ceftolozane in combination with metronidazole in Japanese patients with complicated intra-abdominal infections. ( Fujimoto, G; Fukuhara, T; Horiuchi, T; Mikamo, H; Miyasaka, Y; Monden, K; Rhee, EG; Shizuya, T; Yoshinari, T, 2019)
" Adverse events were similar between the study groups."	6.84	A randomised, double-blind, phase 3 study comparing the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem for complicated intra-abdominal infections in hospitalised adults in Asia. ( Chen, Q; Chow, JW; Kim, MJ; Laud, PJ; Nguyen, DA; Qin, X; Song, J; Stone, GG; Tran, BG; Wang, L, 2017)
"Ceftolozane/tazobactam, a cephalosporin-β-lactamase inhibitor combination, is approved for the treatment of complicated urinary tract infections and complicated intra-abdominal infections (cIAI)."	5.69	Safety and Efficacy of Ceftolozane/Tazobactam Plus Metronidazole Versus Meropenem From a Phase 2, Randomized Clinical Trial in Pediatric Participants With Complicated Intra-abdominal Infection. ( Bensaci, M; Bruno, CJ; De Anda, C; Dementieva, N; Huntington, JA; Jackson, CA; Johnson, MG; Lonchar, J; Newland, J; Popejoy, MW; Rhee, EG; Su, FH, 2023)
"Metronidazole is frequently used off-label in infants with complicated intra-abdominal infections (cIAI) to provide coverage against anaerobic organisms, but its safety and efficacy in this indication are unknown."	5.34	Safety of Metronidazole in Late Pre-term and Term Infants with Complicated Intra-abdominal Infections. ( Benjamin, D; Bumpass, TG; Cohen-Wolkowiez, M; Commander, SJ; Courtney, SE; Debski, J; Delmore, P; Erinjeri, J; Gao, J; Heresi, G; Hornik, CP; Lavery, AP; Moya, F; Sharma, G; Smith, PB; Sokol, GM; Tracy, ET; Zinkhan, EK, 2020)
" Ceftolozane/tazobactam is an antibacterial with potent activity against Gram-negative pathogens and is approved for the treatment of cIAI (with metronidazole) and cUTI (including pyelonephritis)."	5.24	Analysis of patients with diabetes and complicated intra-abdominal infection or complicated urinary tract infection in phase 3 trials of ceftolozane/tazobactam. ( Huntington, JA; Long, J; Popejoy, MW, 2017)
" The characteristics and outcomes of patients infected with ESBL-ENT were examined in a pooled analysis of Phase 3 clinical trials of ceftolozane/tazobactam in patients with complicated urinary tract infections (ASPECT-cUTI) and complicated intra-abdominal infections (ASPECT-cIAI)."	5.24	Efficacy of ceftolozane/tazobactam against urinary tract and intra-abdominal infections caused by ESBL-producing Escherichia coli and Klebsiella pneumoniae: a pooled analysis of Phase 3 clinical trials. ( Bliss, CA; Cloutier, D; Hershberger, E; Huntington, JA; Kaye, KS; Miller, B; Paterson, DL; Popejoy, MW; Steenbergen, JN; Umeh, O, 2017)
"The in vitro activities of ceftolozane-tazobactam, meropenem, and metronidazole were determined against anaerobic organisms isolated from patients with complicated intraabdominal infections (cIAI) in global phase III studies."	5.22	In Vitro Activity of Ceftolozane-Tazobactam against Anaerobic Organisms Identified during the ASPECT-cIAI Study. ( Armstrong, ES; Farrell, DJ; Palchak, M; Steenbergen, JN, 2016)
" Efficacy and safety of ceftazidime-avibactam plus metronidazole were compared with meropenem in 1066 men and women with complicated intra-abdominal infections from 2 identical, randomized, double-blind phase 3 studies (NCT01499290 and NCT01500239)."	5.22	Efficacy and Safety of Ceftazidime-Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infection: Results From a Randomized, Controlled, Double-Blind, Phase 3 Program. ( Armstrong, J; Broadhurst, H; Gasink, LB; Llorens, L; Mazuski, JE; Newell, P; Pachl, J; Rank, D; Stone, GG, 2016)
"Ceftolozane-tazobactam is active against Gram-negative pathogens, including multidrug-resistant Pseudomonas aeruginosa In a subgroup analysis of patients with complicated intra-abdominal infections (cIAIs) involving P."	5.22	Characteristics and Outcomes of Complicated Intra-abdominal Infections Involving Pseudomonas aeruginosa from a Randomized, Double-Blind, Phase 3 Ceftolozane-Tazobactam Study. ( Alverdy, J; Hershberger, E; Miller, B; Popejoy, MW; Steenbergen, JN, 2016)
"ASPECT-cIAI (Assessment of the Safety Profile and Efficacy of Ceftolozane/Tazobactam in Complicated Intra-abdominal Infections) was a prospective, randomized, double-blind trial."	5.20	Ceftolozane/Tazobactam Plus Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results From a Randomized, Double-Blind, Phase 3 Trial (ASPECT-cIAI). ( Barie, PS; Collins, S; Eckmann, C; Friedland, I; Hershberger, E; Miller, B; Popejoy, M; Solomkin, J; Steenbergen, J; Yoon, M; Yuan, G, 2015)
"Ceftolozane-tazobactam (TOL-TAZ) is a novel antibacterial with activity against Pseudomonas aeruginosa and other common Gram-negative pathogens, including extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, that are associated with complicated intra-abdominal infections (cIAIs)."	5.19	Multicenter, double-blind, randomized, phase II trial to assess the safety and efficacy of ceftolozane-tazobactam plus metronidazole compared with meropenem in adult patients with complicated intra-abdominal infections. ( Friedland, I; Hershberger, E; Lucasti, C; Miller, B; Solomkin, J; Steenbergen, J; Yankelev, S, 2014)
"Avibactam, a novel non-β-lactam β-lactamase inhibitor, restores the in vitro activity of ceftazidime against class A, C and some class D β-lactamase-producing pathogens, including those commonly associated with complicated intra-abdominal infections (cIAIs)."	5.17	Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, Phase II trial. ( Lipka, J; Lucasti, C; Popescu, I; Ramesh, MK; Sable, C, 2013)
"This randomized, open-label, multi-center trial compared tigecycline (TGC), a broad-spectrum glycylcycline, with ceftriaxone-metronidazole (CTX/MET) for the treatment of complicated intra-abdominal infections (cIAI)."	5.16	Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. ( Babinchak, T; Leister-Tebbe, H; McGovern, PC; Pedersen, R; Qvist, N; Warren, B; Zito, ET, 2012)
"Metronidazole is commonly prescribed for intra-abdominal infections."	4.02	Improving metronidazole prescription practices in surgical patients: a full cycle audit. ( Sgrò, A; Wu, DA; Yalamarthi, S, 2021)
"Safety data from seven multicentre, randomised, active-comparator studies were pooled by study group at the patient level for descriptive analyses, comprising patients with complicated urinary tract infection (cUTI), including pyelonephritis, complicated intra-abdominal infection (cIAI), or nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP), treated with ceftazidime-avibactam ± metronidazole or comparator."	3.96	Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. ( Broadhurst, H; Cheng, K; Chow, JW; Newell, P; Wardman, A; Wilson, D; Yates, K, 2020)
" Secondary endpoints included clinical and microbiologic responses at the TOC and end-of-treatment (≤24 hours after last dose) visits and adverse event rates."	3.11	A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections. ( Bensaci, M; Bruno, CJ; Chen, G; Chen, X; Du, X; Fan, J; Huntington, JA; Johnson, MG; Sun, F; Sun, Y; Wang, H; Wang, Y, 2022)
" Statistically significant trends were observed favoring cefotaxime plus metronidazole, which exhibited fewer discontinuations because of adverse events (AEs) when compared with eravacycline, meropenem and ceftolozane/tazobactam plus metronidazole (OR = 0."	3.01	Efficacy, safety, and tolerability of antimicrobial agents for complicated intra-abdominal infection: a systematic review and network meta-analysis. ( Deng, T; Kong, W; Li, S; Shu, Y; Wu, Y, 2023)
"gov Identifier: NCT02739997) to investigate the efficacy and safety of tazobactam/ceftolozane used in combination with metronidazole in Japanese patients with cIAI was conducted."	2.90	The efficacy and safety of tazobactam/ceftolozane in combination with metronidazole in Japanese patients with complicated intra-abdominal infections. ( Fujimoto, G; Fukuhara, T; Horiuchi, T; Mikamo, H; Miyasaka, Y; Monden, K; Rhee, EG; Shizuya, T; Yoshinari, T, 2019)
" A blinded observer determined adverse event (AE) causality, and clinical outcomes up to the late follow-up visit."	2.90	Safety and Efficacy of Ceftazidime-Avibactam Plus Metronidazole in the Treatment of Children ≥3 Months to <18 Years With Complicated Intra-Abdominal Infection: Results From a Phase 2, Randomized, Controlled Trial. ( Bradley, JS; Broadhurst, H; Cheng, K; Gardner, A; Mendez, M; Newell, P; Prchlik, M; Stone, GG; Talley, AK; Tawadrous, M; Wajsbrot, D; Yates, K; Zuzova, A, 2019)
"This observational study demonstrated that TAZ/CTLZ in combination with metronidazole has a favorable effect without major drug-related adverse events for intraabdominal infection in the hepato-biliary-pancreatic field in clinical practice although the efficacy of TAZ/CTLZ may decrease in compromised patients."	1.91	Efficacy and safety of tazobactam/ceftolozane in combination with metronidazole for intraabdominal infection in a hepato-biliary-pancreatic field in clinical practice. ( Ishizawa, T; Kimura, K; Kinoshita, M; Kubo, S; Nishio, K; Ohira, G; Okada, T; Shinkawa, H; Shirai, D; Tanaka, S; Tani, N; Tauchi, J, 2023)
"Hence the diagnosis of pseudomembranous colitis became apparent."	1.40	Emphysematous cystitis due to recurrent Clostridium difficile infection. ( Dees, A; Jonkman, JG; van Genderen, ME; van Rijn, M, 2014)
"Metronidazole was used only for resistant cases of trichomoniasis, with a cure rate of over 80% when both partners were treated simultaneously."	1.24	CLINICAL TRIALS WITH AGENTS CURRENTLY USED IN THE MANAGEMENT OF VAGINITIS. ( O'BRIEN, JR, 1964)

Research

Studies (48)

Timeframe	Studies, this research(%)	All Research%
pre-1990	17 (35.42)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	22 (45.83)	24.3611
2020's	9 (18.75)	2.80

Authors

Authors	Studies
Rodgers, P	1
Kamat, S	1
Adhav, C	1
Sun, Y	1
Fan, J	1
Chen, G	1
Chen, X	1
Du, X	1
Wang, Y	1
Wang, H	1
Sun, F	1
Johnson, MG	2
Bensaci, M	2
Huntington, JA	4
Bruno, CJ	2
Shi, X	1
Fu, J	1
Li, X	1
Lv, Q	1
Wan, X	1
Xu, Q	1
Jackson, CA	1
Newland, J	1
Dementieva, N	1
Lonchar, J	1
Su, FH	1
Popejoy, MW	4
De Anda, C	1
Rhee, EG	2
Kong, W	1
Deng, T	1
Li, S	1
Shu, Y	1
Wu, Y	1
Kubo, S	1
Shinkawa, H	1
Tanaka, S	1
Kimura, K	1
Ohira, G	1
Nishio, K	1
Kinoshita, M	1
Tauchi, J	1
Shirai, D	1
Okada, T	1
Tani, N	1
Ishizawa, T	1
Silva-Nunes, J	1
Cardoso, T	1
Commander, SJ	1
Gao, J	1
Zinkhan, EK	1
Heresi, G	1
Courtney, SE	1
Lavery, AP	1
Delmore, P	1
Sokol, GM	1
Moya, F	1
Benjamin, D	1
Bumpass, TG	1
Debski, J	1
Erinjeri, J	1
Sharma, G	1
Tracy, ET	1
Smith, PB	2
Cohen-Wolkowiez, M	2
Hornik, CP	1
Cheng, K	2
Newell, P	3
Chow, JW	2
Broadhurst, H	3
Wilson, D	1
Yates, K	2
Wardman, A	1
Sgrò, A	1
Wu, DA	1
Yalamarthi, S	1
Qin, X	1
Tran, BG	1
Kim, MJ	1
Wang, L	1
Nguyen, DA	1
Chen, Q	1
Song, J	1
Laud, PJ	1
Stone, GG	3
Long, J	1
Prabhu, V	1
Foo, J	1
Ahir, H	1
Sarpong, E	1
Merchant, S	1
van Zwetselaar, M	1
Nyombi, B	1
Sonda, T	1
Kumburu, H	1
Chamba, N	1
Dekker, MCJ	1
Kilonzo, KG	1
Urasa, SJ	1
Mmbaga, BT	1
Mikamo, H	1
Monden, K	1
Miyasaka, Y	1
Horiuchi, T	1
Fujimoto, G	1
Fukuhara, T	1
Yoshinari, T	1
Shizuya, T	1
Bradley, JS	1
Mendez, M	1
Prchlik, M	1
Talley, AK	1
Tawadrous, M	1
Wajsbrot, D	1
Zuzova, A	1
Gardner, A	1
Lucasti, C	2
Hershberger, E	5
Miller, B	4
Yankelev, S	1
Steenbergen, J	2
Friedland, I	2
Solomkin, J	2
Sampson, MR	1
Bloom, BT	1
Arrieta, A	1
Capparelli, E	1
Benjamin, DK	1
Kearns, GL	1
van den Anker, J	1
van Genderen, ME	1
Jonkman, JG	1
van Rijn, M	1
Dees, A	1
Popejoy, M	1
Yoon, M	1
Collins, S	1
Yuan, G	1
Barie, PS	1
Eckmann, C	2
Spellberg, B	1
Brass, EP	1
Solomkin, JS	1
Armstrong, ES	1
Farrell, DJ	1
Palchak, M	1
Steenbergen, JN	3
Mazuski, JE	2
Gasink, LB	1
Armstrong, J	1
Rank, D	1
Llorens, L	1
Pachl, J	1
Alverdy, J	1
Gergely Szabo, B	1
Kadar, B	1
Szidonia Lenart, K	1
Dezsenyi, B	1
Kunovszki, P	1
Fried, K	1
Kamotsay, K	1
Nikolova, R	1
Prinz, G	1
Paterson, DL	1
Cloutier, D	1
Bliss, CA	1
Umeh, O	1
Kaye, KS	1
Buckman, SA	1
Krekel, T	1
Muller, AE	1
Tan, TY	1
Ng, LS	1
Kwang, LL	1
Rao, S	1
Eng, LC	1
Qvist, N	1
Warren, B	1
Leister-Tebbe, H	1
Zito, ET	1
Pedersen, R	1
McGovern, PC	1
Babinchak, T	1
Popescu, I	1
Ramesh, MK	1
Lipka, J	1
Sable, C	1
DUREL, P	1
COUTURE, J	1
COLLART, P	1
GIROT, C	1
WATT, L	2
JENNISON, RF	2
GRAY, MS	1
STREETER, RT	1
WEST, WT	1
TEOKHAROV, BA	1
ANIKIN, AF	1
KLINYSHKOVA, VM	1
WALL, JA	1
JAKOBOVITS, A	1
SZELL, I	1
O'BRIEN, JR	1
BARENTS, JW	1
MOFFETT, M	1
MCGILL, MI	1
JAMESON, WJ	1
KUNZ, L	1
HAUSER, GA	1
LUNDSTROM, P	1
RINDI, V	1
MASCIADRI GASBARRO, O	1

Clinical Trials (14)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 3, Multicenter, Double-blind, Randomized, Active-controlled Clinical Study to Evaluate the Efficacy and Safety of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Chinese Participants With Complicated Intra-abdominal Infect[NCT03830333]	Phase 3	268 participants (Actual)	Interventional	2019-03-20	Completed
A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects With Complicated Intra-Abdominal [NCT03217136]	Phase 2	94 participants (Actual)	Interventional	2018-04-03	Completed
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Thera[NCT01595438]	Phase 3	598 participants (Actual)	Interventional	2012-10-31	Completed
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens[NCT01644643]	Phase 3	345 participants (Actual)	Interventional	2013-01-31	Completed
A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-A[NCT01808092]	Phase 3	969 participants (Actual)	Interventional	2013-04-30	Completed
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Thera[NCT01599806]	Phase 3	641 participants (Actual)	Interventional	2012-10-31	Completed
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdo[NCT01499290]	Phase 3	493 participants (Actual)	Interventional	2012-03-31	Completed
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdo[NCT01726023]	Phase 3	486 participants (Actual)	Interventional	2013-01-31	Completed
A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Efficacy and Safety of Intravenous CXA-201 With That of Meropenem in Complicated Intraabdominal Infections[NCT01445678]	Phase 3	494 participants (Actual)	Interventional	2011-12-23	Completed
A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis[NCT01345929]	Phase 3	558 participants (Actual)	Interventional	2011-06-20	Completed
A Multicenter, Open-label, Noncomparative, Japanese Phase III Study to Assess the Efficacy and Safety of Ceftolozane/Tazobactam (MK-7625A) Used in Combination With Metronidazole in Japanese Patients With Complicated Intra-abdominal Infection.[NCT02739997]	Phase 3	100 participants (Actual)	Interventional	2016-04-08	Completed
A Single Blind, Randomised, Multi-centre, Active Controlled, Trial To Evaluate Safety, Tolerability, Pharmacokinetics And Efficacy Of Ceftazidime And Avibactam When Given In Combination With Metronidazole, Compared With Meropenem, In Children From 3 Month[NCT02475733]	Phase 2	83 participants (Actual)	Interventional	2015-08-01	Completed
A Multicenter, Double-Blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA 101/ Tazobactam and Metronidazole With That of Meropenem in Complicated Intraabdominal Infections[NCT01147640]	Phase 2	122 participants (Actual)	Interventional	2010-06-25	Completed
A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection[NCT00230971]	Phase 4	473 participants (Actual)	Interventional	2005-10-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percentage of Participants That Discontinued Study Treatment Due to an AE

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The percentage of participants who had study drug discontinued during the study due to an AE was summarized. (NCT03830333)
Timeframe: Up to Day 14

Intervention	Percentage of Participants (Number)
Ceftolozane/Tazobactam + Metronidazole	2.2
Meropenem + Placebo	2.2

Percentage of Participants Who Experienced 1 or More Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The percentage of participants who experienced 1 or more AEs were summarized. (NCT03830333)
Timeframe: Up to approximately Day 30

Intervention	Percentage of Participants (Number)
Ceftolozane/Tazobactam + Metronidazole	50.0
Meropenem + Placebo	50.7

Percentage of Participants With Favorable Per-Participant Microbiological Response of Eradication or Presumed Eradication at TOC Visit: Expanded Microbiologically Evaluable (EME) Population

An overall microbiological response was determined by the Sponsor for each participant based on individual microbiological responses for each baseline bacterial pathogen. A favorable individual microbiological response was eradication (absence of the baseline bacterial pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a participant who is assessed as a clinical cure). In order for the participant to have a favorable overall microbiological response, each individual baseline bacterial pathogen must have had a favorable microbiological outcome. The percentage of participants with a favorable per-participant microbiological response of eradication or presumed eradication was reported for the TOC visit. (NCT03830333)
Timeframe: Up to approximately Day 30

Intervention	Percentage of Participants (Number)
Ceftolozane/Tazobactam + Metronidazole	94.4
Meropenem + Placebo	93.2

Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at End of Therapy (EOT) Visit: CE Population

"Clinical response was classified as cure or failure. Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. The percentage of participants with clinical response of clinical cure or clinical failure at EOT was summarized." (NCT03830333)
Timeframe: Up to approximately Day 15

Intervention	Percentage of Participants (Number)
	Clinical Cure (favorable)	Clinical Failure (unfavorable)
Ceftolozane/Tazobactam + Metronidazole	98.1	1.9
Meropenem + Placebo	96.6	3.4

Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population

"Clinical response was classified as cure or failure. Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. The percentage of participants with clinical response of clinical cure or clinical failure at TOC was summarized." (NCT03830333)
Timeframe: Up to approximately Day 30

Intervention	Percentage of Participants (Number)
	Clinical Cure (favorable)	Clinical Failure (unfavorable)
Ceftolozane/Tazobactam + Metronidazole	95.2	4.8
Meropenem + Placebo	93.1	6.9

Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at EOT Visit: ITT Population

"Clinical response was classified as cure, failure, or indeterminate. Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate (unfavorable) was defined as participants for whom study data are not available for evaluation of efficacy for any reason. The percentage of participants with clinical response of clinical cure, clinical failure, or indeterminate at EOT was summarized." (NCT03830333)
Timeframe: Up to approximately Day 15

Intervention	Percentage of Participants (Number)
	Clinical Cure (favorable)	Clinical Failure (unfavorable)	Indeterminate (unfavorable)
Ceftolozane/Tazobactam + Metronidazole	92.5	7.5	0.0
Meropenem + Placebo	94.0	4.5	1.5

Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population

"Clinical response was classified as cure, failure, or indeterminate. Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate (unfavorable) was defined as participants for whom study data were not available for evaluation of efficacy for any reason. The percentage of participants with clinical response of clinical cure, clinical failure, or indeterminate at TOC was summarized." (NCT03830333)
Timeframe: Up to approximately Day 30

Intervention	Percentage of Participants (Number)
	Clinical Cure (favorable)	Clinical Failure (unfavorable)	Indeterminate (unfavorable)
Ceftolozane/Tazobactam + Metronidazole	85.1	14.2	0.7
Meropenem + Placebo	89.6	9.7	0.7

Percentage of Participants With Favorable Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the TOC Visit: EME Population

A microbiological response was determined for each bacterial pathogen isolated at baseline by the Sponsor. Favorable microbiological responses included eradication (absence of the baseline bacterial pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a participant who is assessed as a clinical cure). The percentage of participants with a favorable microbiological response of eradication or presumed eradication was reported per pathogen for the TOC visit. (NCT03830333)
Timeframe: Up to approximately Day 30

Intervention	Percentage of Participants (Number)
	Gram-negative aerobes	All Enterobacteriaceae	Other Enterobacter spp.	Escherichia coli	Klebsiella oxytoca	Klebsiella pneumoniae	Morganella morganii	Pseudomonas aeruginosa	Gram-positive aerobes	Gram-negative anaerobes	Gram-positive anaerobes
Meropenem + Placebo	95.0	95.0	100.0	95.7	100.0	90.9	100.0	100.0	88.2	100.0	100.0

Percentage of Participants With Favorable Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the TOC Visit: EME Population

Intervention	Percentage of Participants (Number)
	Gram-negative aerobes	All Enterobacteriaceae	Citrobacter freundii complex	Citrobacter koseri	Enterobacter aerogenes	Enterobacter cloacae complex	Escherichia coli	Klebsiella pneumoniae	Proteus mirabilis	Aeromonas hydrophila	Pseudomonas aeruginosa	Gram-positive aerobes	Gram-positive anaerobes
Ceftolozane/Tazobactam + Metronidazole	94.0	93.8	100.0	100.0	100.0	100.0	93.8	100.0	50.0	100.0	75.0	80.0	100.0

"Percentage of Participants With a Clinical Response of Cure at the End of Treatment (EOT) Visit"

"The percentage of participants who had a clinical outcome of cure at the time of the EOT visit is presented. The cure clinical outcome was defined as complete resolution or marked improvement in signs and symptoms of the complicated intra-abdominal infection (cIAI) or return to pre-infection signs and symptoms such that no further antibiotic therapy (intravenous or oral) or surgical or drainage procedure is required for treatment of the cIAI. Participants who were missing clinical response data were considered treatment failures." (NCT03217136)
Timeframe: Up to approximately 27 days

Intervention	Percentage of participants (Number)
Ceftolozane/Tazobactam + Metronidazole	80.0
Meropenem	95.2

"Percentage of Participants With a Clinical Response of Cure at the Test of Cure (TOC) Visit"

"The percentage of participants who had a clinical outcome of cure at the time of the TOC visit is presented. The cure clinical outcome was defined as complete resolution or marked improvement in signs and symptoms of the complicated intra-abdominal infection (cIAI) or return to pre-infection signs and symptoms such that no further antibiotic therapy (intravenous or oral) or surgical or drainage procedure is required for treatment of the cIAI. Participants who were missing clinical response data were considered treatment failures." (NCT03217136)
Timeframe: Up to approximately 39 days

Intervention	Percentage of participants (Number)
Ceftolozane/Tazobactam + Metronidazole	80.0
Meropenem	100.0

Number of Participants Experiencing ≥1 Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented. (NCT03217136)
Timeframe: Up to approximately 75 days

Intervention	Participants (Count of Participants)
Ceftolozane/Tazobactam + Metronidazole	56
Meropenem	13

Number of Participants Who Discontinued Study Therapy Due to AE(s)

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented. (NCT03217136)
Timeframe: Up to approximately 18 days

Intervention	Participants (Count of Participants)
Ceftolozane/Tazobactam + Metronidazole	2
Meropenem	0

Percentage of Participants With Microbiological Eradication at the EOT Visit

The percentage of participants who achieved either eradication or presumed eradication of each baseline infecting pathogen by the time of the EOT visit is presented. Eradication was defined as absence of the baseline pathogen(s) in a postbaseline specimen appropriately obtained from the original site of infection. Presumed eradication was defined as absence of material to culture in a participant who is assessed as having partial improvement, or clinical cure. In the event of multiple baseline pathogens, the least favorable microbiological response from all possible baseline pathogens was used. (NCT03217136)
Timeframe: Up to approximately 27 days

Intervention	Percentage of participants (Number)
Ceftolozane/Tazobactam + Metronidazole	84.1
Meropenem	94.7

Percentage of Participants With Microbiological Eradication at the TOC Visit

The percentage of participants who achieved either eradication or presumed eradication of each baseline infecting pathogen by the time of the TOC visit is presented. Eradication was defined as absence of the baseline pathogen(s) in a postbaseline specimen appropriately obtained from the original site of infection. Presumed eradication was defined as absence of material to culture in a participant who is assessed as having partial improvement, or clinical cure. In the event of multiple baseline pathogens, the least favorable microbiological response from all possible baseline pathogens was used. (NCT03217136)
Timeframe: Up to approximately 39 days

Intervention	Percentage of participants (Number)
Ceftolozane/Tazobactam + Metronidazole	84.1
Meropenem	100

Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 30 to 90 minutes after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	6587.2

Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 300 to 360 minutes after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	1883.2

Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: within 15 minutes before/after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	9307.3

Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 30 to 90 minutes after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	47575.1

Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 300 to 360 minutes after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	16959.6

Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: within 15 minutes before/after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	65481.2

Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	280	81	32
Doripenem	269	109	39

Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	346	4
Doripenem	387	4

Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	327	4	5
Doripenem	368	2	1

Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	318	4	3
Doripenem	358	2	1

Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	378	5	10
Doripenem	407	5	5

Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	235	19
Doripenem	254	33

Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	232	15	4
Doripenem	246	24	2

Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	226	15	4
Doripenem	236	24	2

Investigator Determined Clinical Response at LFU (mMITT Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	335	23	35
Doripenem	350	39	28

Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	289	8
Doripenem	309	21

Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	283	4	5
Doripenem	298	13	0

Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	277	4	5
Doripenem	285	13	0

Investigator Determined Clinical Response at TOC (mMITT Analysis Set)

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	355	11	27
Doripenem	377	24	16

Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	All patients - Clinical cure (n=51, 63)	Escherichia coli patients - Clin cure (n=23, 27)	Klebsiella pneumoniae patients-Clin cure(n=15, 23)	Pseudomonas aeruginosa patients-Clin cure(n=3,6)	Enterobacter cloacae patients-Clin cure(n=5,5)	Proteus mirabilis patients - Clin cure (n=0, 2)
CAZ-AVI	50	22	15	3	5	0
Doripenem	61	25	23	6	5	2

Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	All patients - Clinical cure (n=48, 57)	Escherichia coli patients-Clin cure (n=23,27)	Klebsiella pneumoniae patients-Clin cure(n=14, 22)	Pseudomonas aeruginosa patients-Clin cure(n=1, 2)	Enterobacter cloacae patients-Clin cure(n=5,5)	Proteus mirabilis patients - Clin cure (n=0, 2)
CAZ-AVI	47	22	14	1	5	0
Doripenem	55	25	22	2	5	2

Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	All patients - Clinical cure (n=75, 84)	Escherichia coli patients - Clin cure (n=36, 37)	Klebsiella pneumoniae patients-Clin cure(n=18,30)	Pseudomonas aeruginosa patients- Clin cure(n=7,6)	Enterobacter cloacae patients-Clin cure(n=7,6)	Proteus mirabilis patients - Clin cure (n=2, 5)
CAZ-AVI	67	33	17	5	5	2
Doripenem	75	31	28	6	5	5

Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01595438)
Timeframe: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.

Intervention	Participants (Number)
	Symptomatic resolution	Symptom persistence	Indeterminate
CAZ-AVI	276	103	14
Doripenem	276	124	17

Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=250, 274)	Klebsiella pneumoniae - Favorable (n=34, 49)	Proteus mirabilis - Favorable (n=13, 11)	Enterobacter cloacae - Favorable (n= 9, 12)	Pseudomonas aeruginosa - Favorable (n=18, 18)
CAZ-AVI	250	34	13	9	17
Doripenem	274	48	11	12	17

Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=249, 270)	Klebsiella pneumoniae - Favorable (n=33, 48)	Proteus mirabilis - Favorable (n=13,11)	Enterobacter cloacae - Favorable (n= 9, 12)	Pseudomonas aeruginosa - Favorable (n=10, 15)
CAZ-AVI	249	33	13	9	9
Doripenem	270	47	11	12	14

Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=292, 306)	Klebsiella pneumoniae - Favorable (n=44, 56)	Proteus mirabilis - Favorable (n=17, 13)	Enterobacter cloacae - Favorable (n= 11,13)	Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI	280	41	16	9	17
Doripenem	293	51	11	13	18

Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=26, 24)	Klebsiella pneumoniae - Favorable (n=2, 1)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	26	1	1	1
Doripenem	24	1	0	2

Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=26, 24)	Klebsiella pneumoniae - Favorable (n=2, 1)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	26	1	1	1
Doripenem	24	1	0	2

Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=32, 28)	Klebsiella pneumoniae - Favorable (n=4, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	31	2	1	1
Doripenem	28	2	0	2

Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=179, 198)	Klebsiella pneumoniae - Favorable (n=31, 36)	Proteus mirabilis - Favorable (n=11,5)	Enterobacter cloacae - Favorable (n= 7, 11)	Pseudomonas aeruginosa - Favorable (n=12, 16)
CAZ-AVI	129	24	11	5	7
Doripenem	131	19	1	8	9

Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=179, 194)	Klebsiella pneumoniae - Favorable (n=30, 35)	Proteus mirabilis - Favorable (n=11,5)	Enterobacter cloacae - Favorable (n= 7, 11)	Pseudomonas aeruginosa - Favorable (n=8, 13)
CAZ-AVI	129	23	11	5	6
Doripenem	127	18	1	8	8

Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=292, 306)	Klebsiella pneumoniae - Favorable (n=44, 56)	Proteus mirabilis - Favorable (n=17, 13)	Enterobacter cloacae - Favorable (n= 11,13)	Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI	198	32	16	6	9
Doripenem	189	30	6	9	13

Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=19, 18)	Klebsiella pneumoniae - Favorable (n=2, 1)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI	19	2	1	0
Doripenem	17	1	0	1

Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=19, 18)	Klebsiella pneumoniae - Favorable (n=2, 1)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI	19	2	1	0
Doripenem	17	1	0	1

Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=32, 28)	Klebsiella pneumoniae - Favorable (n=4, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	29	3	1	1
Doripenem	27	2	0	2

Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=4,4)	E. coli (MIC: 0.015) - Favorable (n=5, 6)	E. coli (MIC: 0.03) - Favorable (n=18, 21)	E. coli (MIC: 0.06) - Favorable (n=95, 111)	E. coli (MIC: 0.12) - Favorable (n=68, 54)	E. coli (MIC: 0.25) - Favorable (n=19, 18)	E. coli (MIC: 0.5) - Favorable (n=2, 5)	E. coli (MIC: 1) - Favorable (n=2, 0)	E. coli (MIC: 2) - Favorable (n=1, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: 32) - Favorable (n=0, 0)	E. coli (MIC: >32) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)	Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)	Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)	Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)	Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)	Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)	Entero. cloacae (MIC: 1)- Favorable (n= 1,4)	Entero. cloacae (MIC: 2)- Favorable (n= 1,0)	Entero. cloacae (MIC: 4)- Favorable (n= 2,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: 32)- Favorable (n= 0,0)	Entero. cloacae (MIC: >32)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)	P.aeruginosa (MIC: 1) - Favorable (n=1,4)	P.aeruginosa (MIC: 2) - Favorable (n=4,5)	P.aeruginosa (MIC: 4) - Favorable (n=5,6)	P.aeruginosa (MIC: 8) - Favorable (n=2,2)	P.aeruginosa (MIC: 16) - Favorable (n=0,1)	P.aeruginosa (MIC: 32) - Favorable (n=0,0)	P.aeruginosa (MIC: >32) - Favorable (n=1,0)
CAZ-AVI	2	5	17	83	56	13	2	1	1	0	0	0	0	0	0	1	1	4	7	1	4	6	2	0	0	0	0	0	0	1	9	4	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	1	1	0	0	0	0	0	0	0	0	0	0	0	1	4	1	1	0	0	1
Doripenem	4	5	17	94	40	8	2	0	0	0	0	0	0	0	0	0	2	7	6	2	8	3	0	0	0	0	0	1	0	0	0	4	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	1	4	0	0	0	0	0	0	0	0	0	0	0	0	0	2	5	4	1	1	0	0

Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=4,4)	E. coli (MIC: 0.015) - Favorable (n=5, 6)	E. coli (MIC: 0.03) - Favorable (n=18, 21)	E. coli (MIC: 0.06) - Favorable (n=95, 111)	E. coli (MIC: 0.12) - Favorable (n=68, 54)	E. coli (MIC: 0.25) - Favorable (n=19, 18)	E. coli (MIC: 0.5) - Favorable (n=2, 5)	E. coli (MIC: 1) - Favorable (n=2, 0)	E. coli (MIC: 2) - Favorable (n=1, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: 32) - Favorable (n=0, 0)	E. coli (MIC: >32) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)	Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)	Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)	Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)	Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)	Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)	Entero. cloacae (MIC: 1)- Favorable (n= 1,4)	Entero. cloacae (MIC: 2)- Favorable (n= 1,0)	Entero. cloacae (MIC: 4)- Favorable (n= 2,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: 32)- Favorable (n= 0,0)	Entero. cloacae (MIC: >32)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)	P.aeruginosa (MIC: 1) - Favorable (n=1,4)	P.aeruginosa (MIC: 2) - Favorable (n=4,4)	P.aeruginosa (MIC: 4) - Favorable (n=3,4)	P.aeruginosa (MIC: 8) - Favorable (n=1,1)	P.aeruginosa (MIC: 16) - Favorable (n=0,0)	P.aeruginosa (MIC: 32) - Favorable (n=0,0)	P.aeruginosa (MIC: >32) - Favorable (n=0,0)
CAZ-AVI	2	5	17	83	56	13	2	1	1	0	0	0	0	0	0	1	1	4	7	1	4	5	2	0	0	0	0	0	0	1	9	4	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	1	1	0	0	0	0	0	0	0	0	0	0	0	1	4	1	1	0	0	0
Doripenem	4	5	17	94	40	8	2	0	0	0	0	0	0	0	0	0	2	7	6	2	8	3	0	0	0	0	0	0	0	0	0	4	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	1	4	0	0	0	0	0	0	0	0	0	0	0	0	0	2	4	3	0	0	0	0

Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=5, 6)	E. coli (MIC: 0.015) - Favorable (n=8, 7)	E. coli (MIC: 0.03) - Favorable (n=28, 35)	E. coli (MIC: 0.06) - Favorable (n=123, 139)	E. coli (MIC: 0.12) - Favorable (n=90, 81)	E. coli (MIC: 0.25) - Favorable (n=28, 25)	E. coli (MIC: 0.5) - Favorable (n=5, 6)	E. coli (MIC: 1) - Favorable (n=3, 0)	E. coli (MIC: 2) - Favorable (n=1, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: 32) - Favorable (n=0, 0)	E. coli (MIC: >32) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16)	Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1)	Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5)	Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6)	Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)	Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2)	Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4)	Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)	Entero. cloacae (MIC: 1)- Favorable (n= 2,5)	Entero. cloacae (MIC: 2)- Favorable (n= 1,0)	Entero. cloacae (MIC: 4)- Favorable (n= 2,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: 32)- Favorable (n= 0,0)	Entero. cloacae (MIC: >32)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.5) - Favorable (n=0,2)	P.aeruginosa (MIC: 1) - Favorable (n=1,4)	P.aeruginosa (MIC: 2) - Favorable (n=5,5)	P.aeruginosa (MIC: 4) - Favorable (n=7,6)	P.aeruginosa (MIC: 8) - Favorable (n=2,2)	P.aeruginosa (MIC: 16) - Favorable (n=1,1)	P.aeruginosa (MIC: 32) - Favorable (n=0,0)	P.aeruginosa (MIC: >32) - Favorable (n=2,0)
CAZ-AVI	3	8	24	103	67	18	4	1	1	0	0	0	0	0	0	1	1	7	9	1	6	6	2	0	0	0	0	0	0	1	10	5	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2	0	0	1	1	1	0	0	0	0	0	0	0	0	0	0	0	1	5	3	1	0	0	2
Doripenem	5	6	23	111	54	13	2	0	0	0	0	0	0	0	0	0	2	8	7	3	11	3	0	0	0	0	0	1	0	0	3	5	0	0	1	0	0	0	0	0	0	0	0	0	0	1	2	1	1	4	0	0	0	0	0	0	0	0	0	0	0	0	2	2	5	4	1	1	0	0

Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=1,1)	E. coli (MIC: 0.015) - Favorable (n=122, 119)	E. coli (MIC: 0.03) - Favorable (n=79, 89)	E. coli (MIC: 0.06) - Favorable (n=10, 8)	E. coli (MIC: 0.12) - Favorable (n=1, 2)	E. coli (MIC: 0.25) - Favorable (n=1, 0)	E. coli (MIC: 0.5) - Favorable (n=0, 0)	E. coli (MIC: 1) - Favorable (n=0, 0)	E. coli (MIC: 2) - Favorable (n=0, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: >16) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0)	Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)	Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)	Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)	Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)	Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)	Entero. cloacae (MIC: 1)- Favorable (n= 0,1)	Entero. cloacae (MIC: 2)- Favorable (n= 0,0)	Entero. cloacae (MIC: 4)- Favorable (n= 0,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: >16)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)	P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)	P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)	P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)	P.aeruginosa (MIC: 1) - Favorable (n=1,3)	P.aeruginosa (MIC: 2) - Favorable (n=1,0)	P.aeruginosa (MIC: 4) - Favorable (n=0,2)	P.aeruginosa (MIC: 8) - Favorable (n=1,1)	P.aeruginosa (MIC: 16) - Favorable (n=2,1)	P.aeruginosa (MIC: >16) - Favorable (n=1,1)
CAZ-AVI	1	106	64	7	1	1	0	0	0	0	0	0	0	0	1	12	7	2	1	1	1	0	0	0	0	1	0	0	1	2	4	6	1	0	0	0	0	0	0	0	1	1	1	0	0	2	0	0	0	0	0	0	0	0	0	2	0	2	2	0	1	0	0	0	1
Doripenem	1	95	70	3	1	0	0	0	0	0	0	0	0	0	1	18	6	2	1	0	0	0	0	1	0	0	0	0	0	1	2	1	0	0	0	0	0	0	0	0	1	1	1	4	0	0	1	0	0	0	0	0	0	0	0	3	2	1	1	2	0	1	1	1	1

Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=1,1)	E. coli (MIC: 0.015) - Favorable (n=122, 119)	E. coli (MIC: 0.03) - Favorable (n=79, 89)	E. coli (MIC: 0.06) - Favorable (n=10, 8)	E. coli (MIC: 0.12) - Favorable (n=1,2)	E. coli (MIC: 0.25) - Favorable (n=1,0)	E. coli (MIC: 0.5) - Favorable (n=0,0)	E. coli (MIC: 1) - Favorable (n=0, 0)	E. coli (MIC: 2) - Favorable (n=0, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: >16) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0)	Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)	Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)	Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)	Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)	Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)	Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)	Entero. cloacae (MIC: 1)- Favorable (n= 0,1)	Entero. cloacae (MIC: 2)- Favorable (n= 0,0)	Entero. cloacae (MIC: 4)- Favorable (n= 0,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: >16)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)	P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)	P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)	P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)	P.aeruginosa (MIC: 1) - Favorable (n=1,3)	P.aeruginosa (MIC: 2) - Favorable (n=1,0)	P.aeruginosa (MIC: 4) - Favorable (n=0,0)	P.aeruginosa (MIC: 8) - Favorable (n=0,0)	P.aeruginosa (MIC: 16) - Favorable (n=0,0)	P.aeruginosa (MIC: >16) - Favorable (n=0,0)
CAZ-AVI	1	106	64	7	1	1	0	0	0	0	0	0	0	0	1	12	7	2	1	1	1	0	0	0	0	0	0	0	1	2	4	6	1	0	0	0	0	0	0	0	1	1	1	0	0	2	0	0	0	0	0	0	0	0	0	2	0	2	2	0	1	0	0	0	0
Doripenem	1	95	70	3	1	0	0	0	0	0	0	0	0	0	1	18	6	2	1	0	0	0	0	0	0	0	0	0	0	1	2	1	0	0	0	0	0	0	0	0	1	1	1	4	0	0	1	0	0	0	0	0	0	0	0	3	2	1	1	2	0	0	0	0	0

Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=1, 3)	E. coli (MIC: 0.015) - Favorable (n=160, 160)	E. coli (MIC: 0.03) - Favorable (n=112, 123)	E. coli (MIC: 0.06) - Favorable (n=14, 10)	E. coli (MIC: 0.12) - Favorable (n=3, 3)	E. coli (MIC: 0.25) - Favorable (n=1, 0)	E. coli (MIC: 0.5) - Favorable (n=0,0)	E. coli (MIC: 1) - Favorable (n=0, 0)	E. coli (MIC: 2) - Favorable (n=0, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: >16) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3)	Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27)	Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1)	Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1)	Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)	Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)	Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5)	Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4)	Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5)	Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1)	Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0)	Entero. cloacae (MIC: 1)- Favorable (n= 0,1)	Entero. cloacae (MIC: 2)- Favorable (n= 0,0)	Entero. cloacae (MIC: 4)- Favorable (n= 0,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: >16)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)	P.aeruginosa (MIC: 0.12) - Favorable (n=2,2)	P.aeruginosa (MIC: 0.25) - Favorable (n=2,5)	P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)	P.aeruginosa (MIC: 1) - Favorable (n=1,4)	P.aeruginosa (MIC: 2) - Favorable (n=1,0)	P.aeruginosa (MIC: 4) - Favorable (n=2,2)	P.aeruginosa (MIC: 8) - Favorable (n=2,1)	P.aeruginosa (MIC: 16) - Favorable (n=2,1)	P.aeruginosa (MIC: >16) - Favorable (n=2,1)
CAZ-AVI	1	127	89	10	1	1	0	0	0	0	0	0	0	0	1	16	10	2	1	1	1	0	0	0	0	1	0	0	1	2	5	6	2	0	0	0	0	0	0	0	2	1	1	0	0	2	0	0	0	0	0	0	0	0	0	2	1	2	2	0	1	1	1	0	2
Doripenem	3	119	86	4	2	0	0	0	0	0	0	0	0	0	2	21	7	2	2	0	0	0	0	1	0	0	0	0	0	1	4	2	2	0	0	0	0	0	0	0	1	2	1	4	0	0	1	0	0	0	0	0	0	0	0	3	2	2	1	3	0	1	1	1	1

Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=214, 226)	Klebsiella pneumoniae - Favorable (n=32, 42)	Proteus mirabilis - Favorable (n=14, 7)	Enterobacter cloacae - Favorable (n= 7, 11)	Pseudomonas aeruginosa - Favorable (n=13, 18)
CAZ-AVI	180	26	14	5	8
Doripenem	176	29	4	8	13

Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=214, 221)	Klebsiella pneumoniae - Favorable (n=31, 41)	Proteus mirabilis - Favorable (n=14, 7)	Enterobacter cloacae - Favorable (n= 7, 11)	Pseudomonas aeruginosa - Favorable (n=9, 13)
CAZ-AVI	180	25	14	5	7
Doripenem	171	28	4	8	9

Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=292, 306)	Klebsiella pneumoniae - Favorable (n=44, 56)	Proteus mirabilis - Favorable (n=17, 13)	Enterobacter cloacae - Favorable (n= 11,13)	Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI	229	33	16	6	12
Doripenem	220	35	9	9	15

Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=22, 20)	Klebsiella pneumoniae - Favorable (n=2, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI	22	2	1	0
Doripenem	20	2	0	1

Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=22, 20)	Klebsiella pneumoniae - Favorable (n=2, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI	22	2	1	0
Doripenem	20	2	0	1

Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=32, 28)	Klebsiella pneumoniae - Favorable (n=4, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	31	3	1	1
Doripenem	28	2	0	2

Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	335	1
Doripenem	369	2

Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	324	1
Doripenem	359	2

Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	374	1	18
Doripenem	395	3	19

Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	184	67
Doripenem	173	99

Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	182	63
Doripenem	166	96

Per-patient Microbiological Response at LFU (mMITT Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	268	83	42
Doripenem	254	125	38

Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)

Number of patients with a favorable per patient microbiological response at TOC (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	243	49
Doripenem	236	75

Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)

Number of patients with a favorable per patient microbiological response at TOC (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	241	45
Doripenem	225	73

Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	304	58	31
Doripenem	296	83	38

Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	37	14
Doripenem	41	22

Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	35	13
Doripenem	37	20

Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	47	19	9
Doripenem	51	27	6

Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

Intervention	Participants (Number)
	Number of patients with fever (>38°C) at baseline	Number afebrile at the time of the last obs	Number censored at the time of the last obs
CAZ-AVI	123	122	1
Doripenem	118	113	5

Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

Intervention	Participants (Number)
	Number of patients with fever (>38°C) at baseline	Number afebrile at the time of the last obs	Number censored at the time of the last obs
CAZ-AVI	124	124	0
Doripenem	111	108	3

Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

Intervention	Participants (Number)
	Number of patients with fever (>38°C) at baseline	Number afebrile at the time of the last obs	Number censored at the time of the last obs
CAZ-AVI	124	124	0
Doripenem	108	105	3

Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)

Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

Intervention	Participants (Number)
	Number of patients with fever (>38°C) at baseline	Number afebrile at the time of the last obs	Number censored at the time of the last obs
CAZ-AVI	157	155	2
Doripenem	150	143	7

Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set

Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration. (NCT01644643)
Timeframe: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug

Intervention	NG/ML (Geometric Mean)
CAZ (1)	23880.3
AVI (1)	3061.3
CAZ (2)	39465.3
AVI (2)	6304.1
CAZ (3)	14904.8
AVI (3)	1769.3

Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set

Intervention	NG/ML (Geometric Mean)
CAZ (1)	74260.2
AVI (1)	10103.8
CAZ (2)	56905.9
AVI (2)	8141.2
CAZ (3)	21442.0
AVI (3)	2425.0

Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set

Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Antibiotics - Clin. cure (n=0,1,0,0)	Carbapenems - Clin. cure (n=0,0,1,1)	Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0)	Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2)	Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0)	First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0)	Fluoroquinolones - Clin. cure (n=0,2,5,1)	Imidazole Derivatives - Clin. cure (n=1,3,0,0)	Other Aminoglycosides-Clin. cure (n=0,0,1,1)	Other Antibacterials-Clin. cure (n=0,1,1,0)	Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0)	Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0)	Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2)
cIAI:Best Available Therapy	0	0	0	1	0	0	0	1	0	0	0	0	2
cIAI:CAZ-AVI + Metronidazole	1	0	0	3	0	0	2	3	0	1	0	1	4
cUTI:Best Available Therapy	0	1	2	0	1	2	5	0	1	1	1	0	2
cUTI:CAZ-AVI	0	1	0	2	0	0	1	0	1	0	0	0	2

Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set

Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization

,,,

Intervention	Participant (Number)
	Antibiotics - Clin. cure (n=0,1,0,0)	Carbapenems - Clin. cure (n=0,0,1,1)	Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,1,0)	Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2)	Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0)	First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0)	Fluoroquinolones - Clin. cure (n=0,2,5,1)	Imidazole Derivatives - Clin. cure (n=1,3,0,0)	Other Aminoglycosides-Clin. cure (n=0,0,0,1)	Other Antibacterials-Clin. cure (n=0,1,1,0)	Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0)	Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0)	Third-Gen.Cephalosporins -Clin. cure(n=2,4,1,2)
cIAI:Best Available Therapy	0	0	0	1	0	0	0	1	0	0	0	0	2
cIAI:CAZ-AVI + Metronidazole	1	0	0	3	0	0	2	3	0	1	0	1	4
cUTI:Best Available Therapy	0	1	1	0	0	2	4	0	0	1	1	0	0
cUTI:CAZ-AVI	0	1	0	2	0	0	1	0	1	0	0	0	2

Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set

Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary. (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization

Intervention	Participant (Number)
	Carbapenems - Clin. cure (n=1,0)	Comb of Sulf/Trime inc Deriv-Clin. cure(n=1,0)	Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=0,2)	Cortico,Po. Comb W/Antibio.-Clin. cure(n=1,0)	First-Gen. Cephalosporins-Clin. cure (n=2,0)	Fluoroquinolones - Clin. cure (n=5,0)	Other Aminoglycosides-Clin. cure (n=0,1)	Other Antibacterials-Clin. cure (n=1,0)	Other Antibio. F. Topic. Use-Clin. cure(n=1,0)	Third-Gen.Cephalosporins -Clin. cure(n=1,1)
cUTI:Best Available Therapy	0	0	0	0	2	4	0	0	1	0
cUTI:CAZ-AVI	0	0	2	0	0	0	1	0	0	1

Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set

Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	E. coli - Clinical cure (n=2, 3, 48, 52)	K. pneumoniae - Clinical cure (n=2, 3, 59, 53)	P. aeruginosa - Clinical cure (n=1, 1, 5, 12)
cIAI:Best Available Therapy	2	2	1
cIAI:CAZ-AVI + Metronidazole	3	3	1
cUTI:Best Available Therapy	47	59	5
cUTI:CAZ-AVI	51	53	12

Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set

Proportion of patients with clinical cure at TOC visit by baseline pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	E. coli - Clinical cure (n=6, 4, 57, 59)	K. pneumoniae - Clinical cure (n=3, 5, 65, 55)	P. aeruginosa - clinical cure (n=1, 1, 5, 14)
cIAI:Best Available Therapy	2	2	1
cIAI:CAZ-AVI + Metronidazole	3	3	1
cUTI:Best Available Therapy	54	61	5
cUTI:CAZ-AVI	53	54	12

Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set

Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Antibiotics - Clin. cure (n=0,1,0,0)	Carbapenems - Clin. cure (n=0,0,1,1)	Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0)	Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2)	Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0)	First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0)	Fluoroquinolones - Clin. cure (n=0,2,5,1)	Imidazole Derivatives - Clin. cure (n=1,3,0,0)	Other Aminoglycosides-Clin. cure (n=0,0,0,1)	Other Antibacterials-Clin. cure (n=0,1,1,0)	Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0)	Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0)	Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2)
cIAI:Best Available Therapy	0	0	0	1	0	0	0	1	0	0	0	0	2
cIAI:CAZ-AVI + Metronidazole	1	0	0	3	0	0	2	3	0	1	0	1	4
cUTI:Best Available Therapy	0	1	2	0	1	2	5	0	0	1	1	0	2
cUTI:CAZ-AVI	0	1	0	2	0	0	1	0	1	0	0	0	2

Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set

Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	At least 1 failed - Clin. cure (n=4,7,12,7)	Antibiotics - Clin. cure (n=0,1,0,0)	Carbapenems - Clin. cure (n=1,0,1,2)	Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0)	Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2)	Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0)	First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0)	Fluoroquinolones - Clin. cure (n=1,2,7,1)	Glycopeptide Antibacterials-Clin. cure (n=1,0,0,0)	Imidazole Derivatives - Clin. cure (n=2,3,0,0)	Other Aminoglycosides-Clin. cure (n=0,0,1,1)	Other Antibacterials-Clin. cure (n=0,1,1,0)	Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0)	Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0)	Third-Gen.Cephalosporins -Clin. cure(n=2,4,3,2)
cIAI:Best Available Therapy	3	0	0	0	1	0	0	0	0	1	0	0	0	0	2
cIAI:CAZ-AVI + Metronidazole	7	1	0	0	3	0	0	2	0	3	0	1	0	1	4
cUTI:Best Available Therapy	12	0	1	2	0	1	2	7	0	0	1	1	1	0	3
cUTI:CAZ-AVI	6	0	1	0	2	0	0	1	0	0	1	0	0	0	2

Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.

Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Clinical cure	Clinical failure	Indeterminate
cIAI:Best Available Therapy	6	0	5
cIAI:CAZ-AVI + Metronidazole	9	0	1
cUTI:Best Available Therapy	136	0	1
cUTI:CAZ-AVI	142	0	2

Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.

Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Clinical cure	Clinical failure
cIAI:Best Available Therapy	5	0
cIAI:CAZ-AVI + Metronidazole	9	0
cUTI:Best Available Therapy	127	0
cUTI:CAZ-AVI	134	0

Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set

Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization

,,,

Intervention	Participant (Number)
	Clinical cure	Clinical failure	Indeterminate
cIAI:Best Available Therapy	6	0	5
cIAI:CAZ-AVI + Metronidazole	8	0	2
cUTI:Best Available Therapy	121	8	8
cUTI:CAZ-AVI	127	5	12

Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set

Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization

Intervention	Participant (Number)
	Clinical cure	Clinical failure	Indeterminate
cUTI:Best Available Therapy	118	13	6
cUTI:CAZ-AVI	123	11	10

Clinical Response at FU1 in EME at FU1 Analysis Set.

Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization

,,,

Intervention	Participant (Number)
	Clinical cure	Clinical failure
cIAI:Best Available Therapy	5	0
cIAI:CAZ-AVI + Metronidazole	7	0
cUTI:Best Available Therapy	110	8
cUTI:CAZ-AVI	120	4

Clinical Response at FU2 in EME at FU2 Analysis Set

Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary. (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization

Intervention	Participant (Number)
	Clinical cure	Clinical failure
cUTI:Best Available Therapy	102	12
cUTI:CAZ-AVI	106	10

Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set

Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Clinical cure	Clinical failure	Indeterminate
cIAI:Best Available Therapy	6	0	5
cIAI:CAZ-AVI + Metronidazole	8	0	2
cUTI:Best Available Therapy	129	2	6
cUTI:CAZ-AVI	132	2	10

Clinical Response at TOC in EME at TOC Analysis Set.

Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Clinical cure	Clinical failure
cIAI:Best Available Therapy	5	0
cIAI:CAZ-AVI + Metronidazole	8	0
cUTI:Best Available Therapy	120	2
cUTI:CAZ-AVI	126	2

Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=2, 3, 51, 55)	Escherichia coli - Unfavorable (n=2, 3, 51, 55)	Kleb. pneumoniae - Favorable (n=2, 4, 60, 52)	Kleb. pneumoniae - Unfavorable (n=2, 4, 60, 52)	Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14)	Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14)
cIAI:Best Available Therapy	2	0	2	0	1	0
cIAI:CAZ-AVI + Metronidazole	3	0	4	0	1	0
cUTI:Best Available Therapy	51	0	60	0	5	0
cUTI:CAZ-AVI	55	0	52	0	14	0

Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=6, 4, 57, 59)	Escherichia coli - Unfavorable (n=6, 4, 57, 59)	Escherichia coli - Indeterminate (n=6, 4, 57, 59)	Kleb. pneumoniae - Favorable (n=3, 5, 65, 55)	Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55)	Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55)	Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14)	Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14)	Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14)
cIAI:Best Available Therapy	2	0	4	2	0	1	1	0	0
cIAI:CAZ-AVI + Metronidazole	3	0	1	4	0	1	1	0	0
cUTI:Best Available Therapy	53	0	4	61	1	3	5	0	0
cUTI:CAZ-AVI	57	0	2	52	0	3	14	0	0

Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization

,,,

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=2, 3, 46, 54)	Escherichia coli - Unfavorable (n=2, 3, 46, 54)	Kleb. pneumoniae - Favorable (n=2, 2, 59, 50)	Kleb. pneumoniae - Unfavorable (n=2, 2, 59, 50)	Pseudo. aeruginosa - Favorable (n=1, 1, 5, 10)	Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 10)
cIAI:Best Available Therapy	2	0	2	0	1	0
cIAI:CAZ-AVI + Metronidazole	3	0	2	0	1	0
cUTI:Best Available Therapy	30	16	38	21	3	2
cUTI:CAZ-AVI	43	11	40	10	8	2

Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization

,,,

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=6, 4, 57, 59)	Escherichia coli - Unfavorable (n=6, 4, 57, 59)	Escherichia coli - Indeterminate (n=6, 4, 57, 59)	Kleb. pneumoniae - Favorable (n=3, 5, 65, 55)	Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55)	Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55)	Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14)	Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14)	Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14)
cIAI:Best Available Therapy	2	0	4	2	0	1	1	0	0
cIAI:CAZ-AVI + Metronidazole	3	0	1	3	0	2	1	0	0
cUTI:Best Available Therapy	33	18	6	39	23	3	3	2	0
cUTI:CAZ-AVI	45	12	2	42	10	3	8	2	4

Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=44, 50)	Escherichia coli - Unfavorable (n=44, 50)	Kleb. pneumoniae - Favorable (n= 56, 46)	Kleb. pneumoniae - Unfavorable (n=56, 46)	Pseudo. aeruginosa - Favorable (n=4, 11)	Pseudo. aeruginosa - Unfavorable (n=4, 11)
cUTI:Best Available Therapy	28	16	33	23	2	2
cUTI:CAZ-AVI	39	11	32	14	9	2

Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=0, 0, 57, 59)	Escherichia coli - Unfavorable (n=0, 0, 57, 59)	Escherichia coli - Indeterminate (n=0, 0, 57, 59)	Kleb. pneumoniae - Favorable (n=0, 0, 65, 55)	Kleb. pneumoniae - Unfavorable (n=0, 0, 65, 55)	Kleb. pneumoniae - Indeterminate (n=0, 0, 65, 55)	Pseudo. aeruginosa - Favorable (n=0, 0, 5, 14)	Pseudo. aeruginosa - Unfavorable (n=0, 0, 5, 14)	Pseudo. aeruginosa - Indeterminate (n=0, 0, 5, 14)
cUTI:Best Available Therapy	32	19	6	35	26	4	2	3	0
cUTI:CAZ-AVI	43	14	2	39	14	2	10	2	2

Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32. (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1)	E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2)	E. coli (MIC: 0.06) - Favorable (n=0, 0, 3, 1)	E. coli (MIC: 0.12) - Favorable (n=2, 1, 18, 18)	E. coli (MIC: 0.25) - Favorable (n=0, 0, 13, 15)	E. coli (MIC: 0.5) - Favorable (n=0, 1, 6, 9)	E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2)	E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1)	E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4)	K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,1,0)	K. pneumoniae (MIC: 0.12) - Favorable (n=0,0,8,5)	K. pneumoniae (MIC: 0.25) - Favorable (n=0,2,11,6)	K. pneumoniae (MIC: 0.5) - Favorable (n=1,0,23,21)	K. pneumoniae (MIC: 1) - Favorable (n=0,0,15,17)	K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2)	K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1)	K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1)	P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1)	P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2)	P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2)	P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1)	P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3)	P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,4)
cIAI:Best Available Therapy	0	0	0	2	0	0	0	0	0	0	0	0	1	0	1	0	0	1	0	0	0	0	0
cIAI:CAZ-AVI + Metronidazole	0	0	0	1	0	1	0	0	0	0	0	2	0	0	1	0	0	0	0	0	1	0	0
cUTI:Best Available Therapy	1	0	3	10	9	4	1	2	2	0	6	7	16	11	1	1	0	0	1	0	0	1	1
cUTI:CAZ-AVI	1	1	1	16	15	9	2	1	4	0	4	5	19	15	2	0	0	1	1	2	0	3	4

Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32. (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1)	E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2)	E. coli (MIC: 0.06) - Favorable (n=1, 0, 3, 2)	E. coli (MIC: 0.12) - Favorable (n=4, 2, 20, 20)	E. coli (MIC: 0.25) - Favorable (n=0, 0, 15, 16)	E. coli (MIC: 0.5) - Favorable (n=0, 1, 8, 11)	E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2)	E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1)	E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4)	K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,2,0)	K. pneumoniae (MIC: 0.12) - Favorable (n=0,1,8,5)	K. pneumoniae (MIC: 0.25) - Favorable (n=0,3,12,6)	K. pneumoniae (MIC: 0.5) - Favorable (n=2,0,24,22)	K. pneumoniae (MIC: 1) - Favorable (n=0,0,16,18)	K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2)	K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1)	K. pneumoniae (MIC: 32) - Favorable (n=0, 0, 1, 0)	K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1)	P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1)	P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2)	P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2)	P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1)	P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3)	P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,5)
cIAI:Best Available Therapy	0	0	0	2	0	0	0	0	0	0	0	0	1	0	1	0	0	0	1	0	0	0	0	0
cIAI:CAZ-AVI + Metronidazole	0	0	0	1	0	1	0	0	0	0	0	2	0	0	1	0	0	0	0	0	0	1	0	0
cUTI:Best Available Therapy	1	0	3	12	10	5	1	2	2	1	6	7	16	11	1	1	0	0	0	1	0	0	1	1
cUTI:CAZ-AVI	1	1	2	16	15	10	2	1	4	0	4	5	19	16	1	0	0	0	1	1	2	0	3	4

Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=2, 3, 49, 53)	Escherichia coli - Unfavorable (n=2, 3, 49, 53)	Kleb. pneumoniae - Favorable (n=2, 3, 60, 53)	Kleb. pneumoniae - Unfavorable (n=2, 3, 60, 53)	Pseudo. aeruginosa - Favorable (n=1, 1, 5, 13)	Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 13)
cIAI:Best Available Therapy	2	0	2	0	1	0
cIAI:CAZ-AVI + Metronidazole	3	0	3	0	1	0
cUTI:Best Available Therapy	34	15	42	18	3	2
cUTI:CAZ-AVI	50	3	45	8	11	2

Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set

Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=6, 4, 57, 59)	Escherichia coli - Unfavorable (n=6, 4, 57, 59)	Escherichia coli - Indeterminate (n=6, 4, 57, 59)	Kleb. pneumoniae - Favorable (n=3, 5, 65, 55)	Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55)	Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55)	Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14)	Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14)	Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14)
cIAI:Best Available Therapy	2	0	4	2	0	1	1	0	0
cIAI:CAZ-AVI + Metronidazole	3	0	1	3	0	2	1	0	0
cUTI:Best Available Therapy	38	16	3	43	19	3	3	2	0
cUTI:CAZ-AVI	52	3	4	46	8	1	11	2	1

Per-patient Microbiological Response at EOT in EME at EOT Analysis Set

"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Favorable	Unfavorable
cIAI:Best Available Therapy	5	0
cIAI:CAZ-AVI + Metronidazole	9	0
cUTI:Best Available Therapy	127	0
cUTI:CAZ-AVI	133	1

Per-patient Microbiological Response at EOT in mMITT Analysis Set

,,,

Intervention	Participant (Number)
	Favorable	Unfavorable	Indeterminate
cIAI:Best Available Therapy	6	0	5
cIAI:CAZ-AVI + Metronidazole	9	0	1
cUTI:Best Available Therapy	130	1	6
cUTI:CAZ-AVI	136	1	7

Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set

"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization

,,,

Intervention	Participant (Number)
	Favorable	Unfavorable
cIAI:Best Available Therapy	5	0
cIAI:CAZ-AVI + Metronidazole	7	0
cUTI:Best Available Therapy	75	45
cUTI:CAZ-AVI	98	28

Per-patient Microbiological Response at FU1 in mMITT Analysis Set

"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization

,,,

Intervention	Participant (Number)
	Favorable	Unfavorable	Indeterminate
cIAI:Best Available Therapy	6	0	5
cIAI:CAZ-AVI + Metronidazole	8	0	2
cUTI:Best Available Therapy	78	50	9
cUTI:CAZ-AVI	103	29	12

Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set

"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization

Intervention	Participant (Number)
	Favorable	Unfavorable
cUTI:Best Available Therapy	68	47
cUTI:CAZ-AVI	85	32

Per-patient Microbiological Response at FU2 in mMITT Analysis Set

"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization

Intervention	Participant (Number)
	Favorable	Unfavorable	Indeterminate
cUTI:Best Available Therapy	73	54	10
cUTI:CAZ-AVI	99	35	10

Per-patient Microbiological Response at TOC in EME at TOC Analysis Set

"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Favorable	Unfavorable
cIAI:Best Available Therapy	5	0
cIAI:CAZ-AVI + Metronidazole	8	0
cUTI:Best Available Therapy	84	40
cUTI:CAZ-AVI	114	17

Per-patient Microbiological Response at TOC in mMITT Analysis Set

"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Favorable	Unfavorable	Indeterminate
cIAI:Best Available Therapy	6	0	5
cIAI:CAZ-AVI + Metronidazole	8	0	2
cUTI:Best Available Therapy	88	42	7
cUTI:CAZ-AVI	118	17	9

The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set

Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair. (NCT01644643)
Timeframe: From first infusion to Day 28

,,,

Intervention	Participant (Number)
	All cause mortality	Deaths due to disease progression	Number of patients with any AE withoutcome=death
cIAI:Best Available Therapy	0	0	0
cIAI:CAZ-AVI + Metronidazole	0	0	0
cUTI:Best Available Therapy	1	0	1
cUTI:CAZ-AVI	1	0	1

The 28 Days All Cause Mortality Rate in mMITT Analysis Set

Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair. (NCT01644643)
Timeframe: From first infusion to Day 28

,,,

Intervention	Participant (Number)
	All cause mortality	Deaths due to disease progression	Number of patients with any AE with outcome=death
cIAI:Best Available Therapy	1	0	1
cIAI:CAZ-AVI + Metronidazole	0	0	0
cUTI:Best Available Therapy	3	0	3
cUTI:CAZ-AVI	3	0	3

The Reason for Treatment Change/Discontinuation in mMITT Analysis Set

Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl) (NCT01644643)
Timeframe: From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.

,,,

Intervention	Participant (Number)
	Treatment Change	Treatment Change - Crcl change	Treatment Change - Other	Treatment discontinuation	Treatment discontinuation - AE	Treatment discontinuation - Other	Treatment interrupted	Treatment interrupted - Change of infusion site
cIAI:Best Available Therapy	1	1	0	4	1	3	0	0
cIAI:CAZ-AVI + Metronidazole	0	0	0	0	0	0	0	0
cUTI:Best Available Therapy	8	5	3	3	1	2	0	0
cUTI:CAZ-AVI	11	10	1	1	1	0	1	1

Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set

"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.

Intervention	participants (Number)
	Favorable	Unfavorable
CAZ-AVI	31	9
Meropenem	36	13

Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable
CAZ-AVI	26	7
Meropenem	29	11

Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit

Intervention	participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	35	10	1
Meropenem	39	13	2

Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable
CAZ-AVI	23	14
Meropenem	21	20

Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable
CAZ-AVI	21	9
Meropenem	18	14

Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit

Intervention	participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	27	16	3
Meropenem	27	23	4

The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set

The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=6, 7)	Enterobacter cloacae (n=22, 17)	Escherichia coli (n=14, 18)	Klebsiella pneumoniae (n=46, 57)	Proteus mirabilis (n=9, 8)	Serratia marcescens (n=13, 10)	Haemophilus influenzae (n=14, 16)	Pseudomonas aeruginosa (n=50, 41)	Staphylococcus aureus (n=18, 26)
CAZ-AVI	4	22	13	39	8	12	14	30	16
Meropenem	5	17	17	53	6	8	16	24	25

The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=6, 7)	Enterobacter cloacae (n=22, 17)	Escherichia coli (n=13, 18)	Klebsiella pneumoniae (n=45, 55)	Proteus mirabilis (n=9, 8)	Serratia marcescens (n=13, 10)	Haemophilus influenzae (n=12, 15)	Pseudomonas aeruginosa (n=38, 34)	Staphylococcus aureus (n=16, 23)
CAZ-AVI	4	22	13	38	8	12	12	22	14
Meropenem	5	17	17	51	6	8	15	19	22

The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=8, 8)	Enterobacter cloacae (n=26, 22)	Escherichia coli (n=17, 20)	Klebsiella pneumoniae (n=59, 71)	Proteus mirabilis (n=14, 12)	Serratia marcescens (n=15, 13)	Haemophilus influenzae (n=16, 25)	Pseudomonas aeruginosa (n=58, 47)	Staphylococcus aureus (n=24, 34)
CAZ-AVI	6	25	15	49	12	12	15	33	21
Meropenem	5	20	18	65	10	11	25	27	32

The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=6, 5)	Enterobacter cloacae (n=21, 11)	Escherichia coli (n=11, 18)	Klebsiella pneumoniae (n=37, 49)	Proteus mirabilis (n=11, 8)	Serratia marcescens (n=12, 8)	Haemophilus influenzae (n=11, 13)	Pseudomonas aeruginosa (n=42, 35)	Staphylococcus aureus (n=14, 22)
CAZ-AVI	5	18	10	29	9	9	11	18	5
Meropenem	3	7	16	39	6	5	12	14	17

The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=6, 5)	Enterobacter cloacae (n=21, 11)	Escherichia coli (n=10, 18)	Klebsiella pneumoniae (n=37, 47)	Proteus mirabilis (n=11, 8)	Serratia marcescens (n=12, 8)	Haemophilus influenzae (n=9, 12)	Pseudomonas aeruginosa (n=31, 28)	Staphylococcus aureus (n=13, 19)
CAZ-AVI	5	18	10	29	9	9	9	13	4
Meropenem	3	7	16	38	6	5	11	12	15

The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=8, 8)	Enterobacter cloacae (n=26, 22)	Escherichia coli (n=17, 20)	Klebsiella pneumoniae (n=59, 71)	Proteus mirabilis (n=14, 12)	Serratia marcescens (n=15, 13)	Haemophilus influenzae (n=16, 25)	Pseudomonas aeruginosa (n=58, 47)	Staphylococcus aureus (n=24, 34)
CAZ-AVI	5	21	13	37	11	10	14	22	11
Meropenem	5	13	16	53	8	8	23	18	25

The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=4, 2)	Enterobacter cloacae (n=6, 5)	Escherichia coli (n=6, 4)	Klebsiella pneumoniae (n=16, 28)	Pseudomonas aeruginosa (n=10, 13)
CAZ-AVI	3	6	5	14	8
Meropenem	2	5	4	25	6

The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=4, 2)	Enterobacter cloacae (n=6, 5)	Escherichia coli (n=5, 4)	Klebsiella pneumoniae (n=16, 26)	Pseudomonas aeruginosa (n=4, 6)
CAZ-AVI	3	6	5	14	3
Meropenem	2	5	4	23	1

The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=4, 2)	Enterobacter cloacae (n=6, 6)	Escherichia coli (n=6, 5)	Klebsiella pneumoniae (n=20, 30)	Pseudomonas aeruginosa (n=11, 15)
CAZ-AVI	3	6	5	18	8
Meropenem	2	6	4	26	7

The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants with favorable responses (Number)
	Enterobacter cloacae (n=5, 5)	Escherichia coli (n=5, 4)	Klebsiella pneumoniae (n=14, 22)	Pseudomonas aeruginosa (n=9, 13)
CAZ-AVI	4	4	11	3
Meropenem	4	4	14	3

The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants with favorable responses (Number)
	Enterobacter cloacae (n=5, 5)	Escherichia coli (n=4, 4)	Klebsiella pneumoniae (n=14, 20)	Pseudomonas aeruginosa (n=3, 6)
CAZ-AVI	4	4	11	1
Meropenem	4	4	13	1

The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit

Intervention	participants with favorable responses (Number)
	Enterobacter aerogenes (n=4, 2)	Enterobacter cloacae (n=6, 6)	Escherichia coli (n=6, 5)	Klebsiella pneumoniae (n=20, 30)	Pseudomonas aeruginosa (n=11, 15)
CAZ-AVI	3	5	4	15	4
Meropenem	2	5	4	18	4

The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set

The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set. (NCT01808092)
Timeframe: up to 25 days from randomization

Intervention	participants (Number)
	Number of patients with admission date	Number of patients with at least one discharge	1 discharge	2 discharges	>2 discharges
CAZ-AVI	170	71	71	0	0
Meropenem	182	75	74	1	0

The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set

The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set. (NCT01808092)
Timeframe: up to 25 days from randomization

Intervention	participants (Number)
	Number of patients with admission date	Number of patients with at least one discharge	1 discharge	2 discharges	>2 discharges
CAZ-AVI	256	148	144	4	0
Meropenem	266	155	151	3	1

The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set

The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set. (NCT01808092)
Timeframe: up to 25 days from randomization

Intervention	participants (Number)
	Number of patients with admission date	Number of patients with at least one discharge	1 discharge	2 discharges	>2 discharges
CAZ-AVI	355	206	201	5	0
Meropenem	366	206	200	4	2

The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable
CAZ-AVI	112	31
Meropenem	123	28

The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable
CAZ-AVI	96	26
Meropenem	112	26

The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	128	38	5
Meropenem	148	31	5

The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable
CAZ-AVI	80	45
Meropenem	89	42

The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable
CAZ-AVI	70	37
Meropenem	83	35

The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set

Intervention	participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	95	64	12
Meropenem	118	54	12

The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set

The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.

Intervention	participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	253	38
Meropenem	268	38

The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set

Intervention	participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	292	50	14
Meropenem	309	45	16

The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set

Intervention	participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	125	18
Meropenem	135	16

The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set

Intervention	participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	110	12
Meropenem	126	12

The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set

Intervention	participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	143	23	5
Meropenem	161	18	5

The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)

The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)

Intervention	participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	199	58
Meropenem	211	59

The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)

Intervention	participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	245	79	32
Meropenem	270	70	30

The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set

Intervention	participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	96	29
Meropenem	103	28

The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set

Intervention	participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	85	22
Meropenem	94	24

The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set

Intervention	participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	120	37	14
Meropenem	138	34	12

The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set

Intervention	participants (Number)
	All (n=39, 49)	Enterobacteriaceae (n=29, 37)	Enterobacter aerogenes (n=4, 2)	Enterobacter cloacae (n=6, 5)	Escherichia coli (n=6, 4)	Klebsiella pneumoniae (n=16, 28)	Gram- pathogens not Enterobacteriaceae (n=10,14)	Pseudomonas aeruginosa (n=10, 13)
CAZ-AVI	35	27	3	6	5	16	8	8
Meropenem	42	31	2	3	3	25	13	12

The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit

Intervention	participants (Number)
	All (n=45, 54)	Enterobacteriaceae (n=34, 41)	Enterobacter aerogenes (n=4, 2)	Enterobacter cloacae (n=6, 6)	Escherichia coli (n=6, 5)	Klebsiella pneumoniae (n=20, 30)	Gram- pathogens not Enterobacteriaceae (n=11,16)	Pseudomonas aeruginosa (n=11, 15)
CAZ-AVI	40	32	3	6	5	20	8	8
Meropenem	45	33	2	4	3	26	14	13

The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set

Intervention	participants (Number)
	All (n=32, 40)	Enterobacteriaceae (n=28, 35)	Enterobacter aerogenes (n=4, 2)	Enterobacter cloacae (n=6, 5)	Escherichia coli (n=5, 4)	Klebsiella pneumoniae (n=16, 26)	Gram- pathogens not Enterobacteriaceae (n=4,7)	Pseudomonas aeruginosa (n=4, 6)
CAZ-AVI	31	27	3	6	5	16	4	4
Meropenem	36	31	2	3	3	25	7	6

The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set

Intervention	participants (Number)
	All (n=36, 41)	Enterobacteriaceae (n=27, 30)	Enterobacter cloacae (n=5, 5)	Escherichia coli (n=5, 4)	Klebsiella pneumoniae (n=14, 22)	Gram- pathogens not Enterobacteriaceae (n=9,13)	Pseudomonas aeruginosa (n=9, 13)
CAZ-AVI	29	23	5	4	12	6	6
Meropenem	32	22	3	3	17	12	12

The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit

Intervention	participants (Number)
	All (n=45, 54)	Enterobacteriaceae (n=34, 41)	Enterobacter aerogenes (n=4, 2)	Enterobacter cloacae (n=6, 6)	Escherichia coli (n=6, 5)	Klebsiella pneumoniae (n=20, 30)	Gram- pathogens not Enterobacteriaceae (n=11,16)	Pseudomonas aeruginosa (n=11, 15)
CAZ-AVI	35	28	3	6	4	16	7	7
Meropenem	40	29	2	4	3	22	13	13

The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set

Intervention	participants (Number)
	All (n=29, 32)	Enterobacteriaceae (n=26, 28)	Enterobacter cloacae (n=5, 5)	Escherichia coli (n=4, 4)	Klebsiella pneumoniae (n=14, 20)	Gram- pathogens not Enterobacteriaceae (n=3,6)	Pseudomonas aeruginosa (n=3, 6)
CAZ-AVI	25	23	5	4	12	2	2
Meropenem	26	22	3	3	17	6	6

The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit

The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)

Intervention	participants (Number)
	Number of patients who died (all cause mortality)	Deaths due to disease progression	Number of patients with any AE with outcome=death	Number of patients alive	Number of patients with unknown survival status
CAZ-AVI	29	10	19	316	11
Meropenem	25	6	19	341	4

The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit

The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)

Intervention	participants (Number)
	Number of patients who died (all cause mortality)	Deaths due to disease progression	Number of patients with any AE with outcome=death	Number of patients alive	Number of patients with unknown survival status
CAZ-AVI	16	6	10	153	2
Meropenem	14	5	9	170	0

The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set

The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)

Intervention	participants (Number)
	Number of patients who died (all cause mortality)	Deaths due to disease progression	Number of patients with any AE with outcome=death	Number of patients alive	Number of patients with unknown survival status
CAZ-AVI	11	5	6	245	1
Meropenem	8	4	4	262	0

The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28

The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28. (NCT01808092)
Timeframe: at Day 28 from randomization

Intervention	participants (Number)
	Number of patients who died (all cause mortality)	Deaths due to disease progression	Number of patients with any AE with outcome=death	Number of patients alive	Number of patients with unknown survival status
CAZ-AVI	30	10	20	315	11
Meropenem	27	6	21	339	4

The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28

The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28. (NCT01808092)
Timeframe: at Day 28 from randomization

Intervention	participants (Number)
	Number of patients who died (all cause mortality)	Deaths due to disease progression	Number of patients with any AE with outcome=death	Number of patients alive	Number of patients with unknown survival status
CAZ-AVI	17	6	11	152	2
Meropenem	16	5	11	168	0

The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28

The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28. (NCT01808092)
Timeframe: at Day 28 from randomization

Intervention	participants (Number)
	Number of patients who died (all cause mortality)	Deaths due to disease progression	Number of patients with any AE with outcome=death	Number of patients alive	Number of patients with unknown survival status
CAZ-AVI	12	5	7	244	1
Meropenem	9	4	5	261	0

Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 30 to 90 minutes after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	6587.2

Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 300 to 360 minutes after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	1883.2

Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: within 15 minutes before/after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	9307.3

Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 30 to 90 minutes after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	47575.1

Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 300 to 360 minutes after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	16959.6

Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: within 15 minutes before/after dose

Intervention	NG/ML (Geometric Mean)
CAZ-AVI	65481.2

Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	280	81	32
Doripenem	269	109	39

Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	346	4
Doripenem	387	4

Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	327	4	5
Doripenem	368	2	1

Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	318	4	3
Doripenem	358	2	1

Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	378	5	10
Doripenem	407	5	5

Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	235	19
Doripenem	254	33

Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	232	15	4
Doripenem	246	24	2

Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	226	15	4
Doripenem	236	24	2

Investigator Determined Clinical Response at LFU (mMITT Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	335	23	35
Doripenem	350	39	28

Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI	289	8
Doripenem	309	21

Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	283	4	5
Doripenem	298	13	0

Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	277	4	5
Doripenem	285	13	0

Investigator Determined Clinical Response at TOC (mMITT Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI	355	11	27
Doripenem	377	24	16

Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	All patients - Clinical cure (n=51, 63)	Escherichia coli patients - Clin cure (n=23, 27)	Klebsiella pneumoniae patients-Clin cure(n=15, 23)	Pseudomonas aeruginosa patients-Clin cure(n=3,6)	Enterobacter cloacae patients-Clin cure(n=5,5)	Proteus mirabilis patients - Clin cure (n=0, 2)
CAZ-AVI	50	22	15	3	5	0
Doripenem	61	25	23	6	5	2

Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	All patients - Clinical cure (n=48, 57)	Escherichia coli patients-Clin cure (n=23,27)	Klebsiella pneumoniae patients-Clin cure(n=14, 22)	Pseudomonas aeruginosa patients-Clin cure(n=1, 2)	Enterobacter cloacae patients-Clin cure(n=5,5)	Proteus mirabilis patients - Clin cure (n=0, 2)
CAZ-AVI	47	22	14	1	5	0
Doripenem	55	25	22	2	5	2

Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	All patients - Clinical cure (n=75, 84)	Escherichia coli patients - Clin cure (n=36, 37)	Klebsiella pneumoniae patients-Clin cure(n=18,30)	Pseudomonas aeruginosa patients- Clin cure(n=7,6)	Enterobacter cloacae patients-Clin cure(n=7,6)	Proteus mirabilis patients - Clin cure (n=2, 5)
CAZ-AVI	67	33	17	5	5	2
Doripenem	75	31	28	6	5	5

Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01599806)
Timeframe: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.

Intervention	Participants (Number)
	Symptomatic resolution	Symptom persistence	Indeterminate
CAZ-AVI	276	103	14
Doripenem	276	124	17

Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=250, 274)	Klebsiella pneumoniae - Favorable (n=34, 49)	Proteus mirabilis - Favorable (n=13, 11)	Enterobacter cloacae - Favorable (n= 9, 12)	Pseudomonas aeruginosa - Favorable (n=18, 18)
CAZ-AVI	250	34	13	9	17
Doripenem	274	48	11	12	17

Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=249, 270)	Klebsiella pneumoniae - Favorable (n=33, 48)	Proteus mirabilis - Favorable (n=13,11)	Enterobacter cloacae - Favorable (n= 9, 12)	Pseudomonas aeruginosa - Favorable (n=10, 15)
CAZ-AVI	249	33	13	9	9
Doripenem	270	47	11	12	14

Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=292, 306)	Klebsiella pneumoniae - Favorable (n=44, 56)	Proteus mirabilis - Favorable (n=17, 13)	Enterobacter cloacae - Favorable (n= 11,13)	Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI	280	41	16	9	17
Doripenem	293	51	11	13	18

Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=26, 24)	Klebsiella pneumoniae - Favorable (n=2, 1)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	26	1	1	1
Doripenem	24	1	0	2

Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=26, 24)	Klebsiella pneumoniae - Favorable (n=2, 1)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	26	1	1	1
Doripenem	24	1	0	2

Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=32, 28)	Klebsiella pneumoniae - Favorable (n=4, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	31	2	1	1
Doripenem	28	2	0	2

Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=179, 198)	Klebsiella pneumoniae - Favorable (n=31, 36)	Proteus mirabilis - Favorable (n=11,5)	Enterobacter cloacae - Favorable (n= 7, 11)	Pseudomonas aeruginosa - Favorable (n=12, 16)
CAZ-AVI	129	24	11	5	7
Doripenem	131	19	1	8	9

Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=179, 194)	Klebsiella pneumoniae - Favorable (n=30, 35)	Proteus mirabilis - Favorable (n=11,5)	Enterobacter cloacae - Favorable (n= 7, 11)	Pseudomonas aeruginosa - Favorable (n=8, 13)
CAZ-AVI	129	23	11	5	6
Doripenem	127	18	1	8	8

Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=292, 306)	Klebsiella pneumoniae - Favorable (n=44, 56)	Proteus mirabilis - Favorable (n=17, 13)	Enterobacter cloacae - Favorable (n= 11,13)	Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI	198	32	16	6	9
Doripenem	189	30	6	9	13

Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=19, 18)	Klebsiella pneumoniae - Favorable (n=2, 1)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI	19	2	1	0
Doripenem	17	1	0	1

Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=19, 18)	Klebsiella pneumoniae - Favorable (n=2, 1)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI	19	2	1	0
Doripenem	17	1	0	1

Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=32, 28)	Klebsiella pneumoniae - Favorable (n=4, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	29	3	1	1
Doripenem	27	2	0	2

Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=4,4)	E. coli (MIC: 0.015) - Favorable (n=5, 6)	E. coli (MIC: 0.03) - Favorable (n=18, 21)	E. coli (MIC: 0.06) - Favorable (n=95, 111)	E. coli (MIC: 0.12) - Favorable (n=68, 54)	E. coli (MIC: 0.25) - Favorable (n=19, 18)	E. coli (MIC: 0.5) - Favorable (n=2, 5)	E. coli (MIC: 1) - Favorable (n=2, 0)	E. coli (MIC: 2) - Favorable (n=1, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: 32) - Favorable (n=0, 0)	E. coli (MIC: >32) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)	Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)	Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)	Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)	Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)	Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)	Entero. cloacae (MIC: 1)- Favorable (n= 1,4)	Entero. cloacae (MIC: 2)- Favorable (n= 1,0)	Entero. cloacae (MIC: 4)- Favorable (n= 2,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: 32)- Favorable (n= 0,0)	Entero. cloacae (MIC: >32)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)	P.aeruginosa (MIC: 1) - Favorable (n=1,4)	P.aeruginosa (MIC: 2) - Favorable (n=4,5)	P.aeruginosa (MIC: 4) - Favorable (n=5,6)	P.aeruginosa (MIC: 8) - Favorable (n=2,2)	P.aeruginosa (MIC: 16) - Favorable (n=0,1)	P.aeruginosa (MIC: 32) - Favorable (n=0,0)	P.aeruginosa (MIC: >32) - Favorable (n=1,0)
CAZ-AVI	2	5	17	83	56	13	2	1	1	0	0	0	0	0	0	1	1	4	7	1	4	6	2	0	0	0	0	0	0	1	9	4	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	1	1	0	0	0	0	0	0	0	0	0	0	0	1	4	1	1	0	0	1
Doripenem	4	5	17	94	40	8	2	0	0	0	0	0	0	0	0	0	2	7	6	2	8	3	0	0	0	0	0	1	0	0	0	4	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	1	4	0	0	0	0	0	0	0	0	0	0	0	0	0	2	5	4	1	1	0	0

Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=4,4)	E. coli (MIC: 0.015) - Favorable (n=5, 6)	E. coli (MIC: 0.03) - Favorable (n=18, 21)	E. coli (MIC: 0.06) - Favorable (n=95, 111)	E. coli (MIC: 0.12) - Favorable (n=68, 54)	E. coli (MIC: 0.25) - Favorable (n=19, 18)	E. coli (MIC: 0.5) - Favorable (n=2, 5)	E. coli (MIC: 1) - Favorable (n=2, 0)	E. coli (MIC: 2) - Favorable (n=1, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: 32) - Favorable (n=0, 0)	E. coli (MIC: >32) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)	Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)	Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)	Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)	Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)	Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)	Entero. cloacae (MIC: 1)- Favorable (n= 1,4)	Entero. cloacae (MIC: 2)- Favorable (n= 1,0)	Entero. cloacae (MIC: 4)- Favorable (n= 2,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: 32)- Favorable (n= 0,0)	Entero. cloacae (MIC: >32)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)	P.aeruginosa (MIC: 1) - Favorable (n=1,4)	P.aeruginosa (MIC: 2) - Favorable (n=4,4)	P.aeruginosa (MIC: 4) - Favorable (n=3,4)	P.aeruginosa (MIC: 8) - Favorable (n=1,1)	P.aeruginosa (MIC: 16) - Favorable (n=0,0)	P.aeruginosa (MIC: 32) - Favorable (n=0,0)	P.aeruginosa (MIC: >32) - Favorable (n=0,0)
CAZ-AVI	2	5	17	83	56	13	2	1	1	0	0	0	0	0	0	1	1	4	7	1	4	5	2	0	0	0	0	0	0	1	9	4	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	1	1	0	0	0	0	0	0	0	0	0	0	0	1	4	1	1	0	0	0
Doripenem	4	5	17	94	40	8	2	0	0	0	0	0	0	0	0	0	2	7	6	2	8	3	0	0	0	0	0	0	0	0	0	4	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	1	4	0	0	0	0	0	0	0	0	0	0	0	0	0	2	4	3	0	0	0	0

Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=5, 6)	E. coli (MIC: 0.015) - Favorable (n=8, 7)	E. coli (MIC: 0.03) - Favorable (n=28, 35)	E. coli (MIC: 0.06) - Favorable (n=123, 139)	E. coli (MIC: 0.12) - Favorable (n=90, 81)	E. coli (MIC: 0.25) - Favorable (n=28, 25)	E. coli (MIC: 0.5) - Favorable (n=5, 6)	E. coli (MIC: 1) - Favorable (n=3, 0)	E. coli (MIC: 2) - Favorable (n=1, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: 32) - Favorable (n=0, 0)	E. coli (MIC: >32) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16)	Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1)	Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5)	Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6)	Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)	Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2)	Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4)	Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)	Entero. cloacae (MIC: 1)- Favorable (n= 2,5)	Entero. cloacae (MIC: 2)- Favorable (n= 1,0)	Entero. cloacae (MIC: 4)- Favorable (n= 2,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: 32)- Favorable (n= 0,0)	Entero. cloacae (MIC: >32)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.5) - Favorable (n=0,2)	P.aeruginosa (MIC: 1) - Favorable (n=1,4)	P.aeruginosa (MIC: 2) - Favorable (n=5,5)	P.aeruginosa (MIC: 4) - Favorable (n=7,6)	P.aeruginosa (MIC: 8) - Favorable (n=2,2)	P.aeruginosa (MIC: 16) - Favorable (n=1,1)	P.aeruginosa (MIC: 32) - Favorable (n=0,0)	P.aeruginosa (MIC: >32) - Favorable (n=2,0)
CAZ-AVI	3	8	24	103	67	18	4	1	1	0	0	0	0	0	0	1	1	7	9	1	6	6	2	0	0	0	0	0	0	1	10	5	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2	0	0	1	1	1	0	0	0	0	0	0	0	0	0	0	0	1	5	3	1	0	0	2
Doripenem	5	6	23	111	54	13	2	0	0	0	0	0	0	0	0	0	2	8	7	3	11	3	0	0	0	0	0	1	0	0	3	5	0	0	1	0	0	0	0	0	0	0	0	0	0	1	2	1	1	4	0	0	0	0	0	0	0	0	0	0	0	0	2	2	5	4	1	1	0	0

Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=1,1)	E. coli (MIC: 0.015) - Favorable (n=122, 119)	E. coli (MIC: 0.03) - Favorable (n=79, 89)	E. coli (MIC: 0.06) - Favorable (n=10, 8)	E. coli (MIC: 0.12) - Favorable (n=1, 2)	E. coli (MIC: 0.25) - Favorable (n=1, 0)	E. coli (MIC: 0.5) - Favorable (n=0, 0)	E. coli (MIC: 1) - Favorable (n=0, 0)	E. coli (MIC: 2) - Favorable (n=0, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: >16) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0)	Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)	Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)	Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)	Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)	Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)	Entero. cloacae (MIC: 1)- Favorable (n= 0,1)	Entero. cloacae (MIC: 2)- Favorable (n= 0,0)	Entero. cloacae (MIC: 4)- Favorable (n= 0,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: >16)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)	P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)	P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)	P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)	P.aeruginosa (MIC: 1) - Favorable (n=1,3)	P.aeruginosa (MIC: 2) - Favorable (n=1,0)	P.aeruginosa (MIC: 4) - Favorable (n=0,2)	P.aeruginosa (MIC: 8) - Favorable (n=1,1)	P.aeruginosa (MIC: 16) - Favorable (n=2,1)	P.aeruginosa (MIC: >16) - Favorable (n=1,1)
CAZ-AVI	1	106	64	7	1	1	0	0	0	0	0	0	0	0	1	12	7	2	1	1	1	0	0	0	0	1	0	0	1	2	4	6	1	0	0	0	0	0	0	0	1	1	1	0	0	2	0	0	0	0	0	0	0	0	0	2	0	2	2	0	1	0	0	0	1
Doripenem	1	95	70	3	1	0	0	0	0	0	0	0	0	0	1	18	6	2	1	0	0	0	0	1	0	0	0	0	0	1	2	1	0	0	0	0	0	0	0	0	1	1	1	4	0	0	1	0	0	0	0	0	0	0	0	3	2	1	1	2	0	1	1	1	1

Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=1,1)	E. coli (MIC: 0.015) - Favorable (n=122, 119)	E. coli (MIC: 0.03) - Favorable (n=79, 89)	E. coli (MIC: 0.06) - Favorable (n=10, 8)	E. coli (MIC: 0.12) - Favorable (n=1,2)	E. coli (MIC: 0.25) - Favorable (n=1,0)	E. coli (MIC: 0.5) - Favorable (n=0,0)	E. coli (MIC: 1) - Favorable (n=0, 0)	E. coli (MIC: 2) - Favorable (n=0, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: >16) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)	Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)	Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0)	Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)	Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)	Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)	Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)	Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)	Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)	Entero. cloacae (MIC: 1)- Favorable (n= 0,1)	Entero. cloacae (MIC: 2)- Favorable (n= 0,0)	Entero. cloacae (MIC: 4)- Favorable (n= 0,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: >16)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)	P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)	P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)	P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)	P.aeruginosa (MIC: 1) - Favorable (n=1,3)	P.aeruginosa (MIC: 2) - Favorable (n=1,0)	P.aeruginosa (MIC: 4) - Favorable (n=0,0)	P.aeruginosa (MIC: 8) - Favorable (n=0,0)	P.aeruginosa (MIC: 16) - Favorable (n=0,0)	P.aeruginosa (MIC: >16) - Favorable (n=0,0)
CAZ-AVI	1	106	64	7	1	1	0	0	0	0	0	0	0	0	1	12	7	2	1	1	1	0	0	0	0	0	0	0	1	2	4	6	1	0	0	0	0	0	0	0	1	1	1	0	0	2	0	0	0	0	0	0	0	0	0	2	0	2	2	0	1	0	0	0	0
Doripenem	1	95	70	3	1	0	0	0	0	0	0	0	0	0	1	18	6	2	1	0	0	0	0	0	0	0	0	0	0	1	2	1	0	0	0	0	0	0	0	0	1	1	1	4	0	0	1	0	0	0	0	0	0	0	0	3	2	1	1	2	0	0	0	0	0

Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	E. coli (MIC: <=0.008) - Favorable (n=1, 3)	E. coli (MIC: 0.015) - Favorable (n=160, 160)	E. coli (MIC: 0.03) - Favorable (n=112, 123)	E. coli (MIC: 0.06) - Favorable (n=14, 10)	E. coli (MIC: 0.12) - Favorable (n=3, 3)	E. coli (MIC: 0.25) - Favorable (n=1, 0)	E. coli (MIC: 0.5) - Favorable (n=0,0)	E. coli (MIC: 1) - Favorable (n=0, 0)	E. coli (MIC: 2) - Favorable (n=0, 0)	E. coli (MIC: 4) - Favorable (n=0, 0)	E. coli (MIC: 8) - Favorable (n=0, 0)	E. coli (MIC: 16) - Favorable (n=0, 0)	E. coli (MIC: >16) - Favorable (n=0, 0)	Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)	Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3)	Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27)	Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16)	Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4)	Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3)	Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1)	Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)	Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0)	Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)	Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)	Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1)	Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)	Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)	Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)	Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)	Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5)	Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4)	Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2)	Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)	Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)	Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)	Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)	Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1)	Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5)	Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1)	Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4)	Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1)	Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0)	Entero. cloacae (MIC: 1)- Favorable (n= 0,1)	Entero. cloacae (MIC: 2)- Favorable (n= 0,0)	Entero. cloacae (MIC: 4)- Favorable (n= 0,0)	Entero. cloacae (MIC: 8)- Favorable (n= 0,0)	Entero. cloacae (MIC: 16)- Favorable (n= 0,0)	Entero. cloacae (MIC: >16)- Favorable (n= 0,0)	P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)	P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)	P.aeruginosa (MIC: 0.12) - Favorable (n=2,2)	P.aeruginosa (MIC: 0.25) - Favorable (n=2,5)	P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)	P.aeruginosa (MIC: 1) - Favorable (n=1,4)	P.aeruginosa (MIC: 2) - Favorable (n=1,0)	P.aeruginosa (MIC: 4) - Favorable (n=2,2)	P.aeruginosa (MIC: 8) - Favorable (n=2,1)	P.aeruginosa (MIC: 16) - Favorable (n=2,1)	P.aeruginosa (MIC: >16) - Favorable (n=2,1)
CAZ-AVI	1	127	89	10	1	1	0	0	0	0	0	0	0	0	1	16	10	2	1	1	1	0	0	0	0	1	0	0	1	2	5	6	2	0	0	0	0	0	0	0	2	1	1	0	0	2	0	0	0	0	0	0	0	0	0	2	1	2	2	0	1	1	1	0	2
Doripenem	3	119	86	4	2	0	0	0	0	0	0	0	0	0	2	21	7	2	2	0	0	0	0	1	0	0	0	0	0	1	4	2	2	0	0	0	0	0	0	0	1	2	1	4	0	0	1	0	0	0	0	0	0	0	0	3	2	2	1	3	0	1	1	1	1

Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=214, 226)	Klebsiella pneumoniae - Favorable (n=32, 42)	Proteus mirabilis - Favorable (n=14, 7)	Enterobacter cloacae - Favorable (n= 7, 11)	Pseudomonas aeruginosa - Favorable (n=13, 18)
CAZ-AVI	180	26	14	5	8
Doripenem	176	29	4	8	13

Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=214, 221)	Klebsiella pneumoniae - Favorable (n=31, 41)	Proteus mirabilis - Favorable (n=14, 7)	Enterobacter cloacae - Favorable (n= 7, 11)	Pseudomonas aeruginosa - Favorable (n=9, 13)
CAZ-AVI	180	25	14	5	7
Doripenem	171	28	4	8	9

Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=292, 306)	Klebsiella pneumoniae - Favorable (n=44, 56)	Proteus mirabilis - Favorable (n=17, 13)	Enterobacter cloacae - Favorable (n= 11,13)	Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI	229	33	16	6	12
Doripenem	220	35	9	9	15

Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=22, 20)	Klebsiella pneumoniae - Favorable (n=2, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI	22	2	1	0
Doripenem	20	2	0	1

Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=22, 20)	Klebsiella pneumoniae - Favorable (n=2, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI	22	2	1	0
Doripenem	20	2	0	1

Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

Intervention	Participant (Number)
	Escherichia coli - Favorable (n=32, 28)	Klebsiella pneumoniae - Favorable (n=4, 2)	Proteus mirabilis - Favorable (n=1, 0)	Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI	31	3	1	1
Doripenem	28	2	0	2

Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	335	1
Doripenem	369	2

Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	324	1
Doripenem	359	2

Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	374	1	18
Doripenem	395	3	19

Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	184	67
Doripenem	173	99

Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	182	63
Doripenem	166	96

Per-patient Microbiological Response at LFU (mMITT Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	268	83	42
Doripenem	254	125	38

Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)

Number of patients with a favorable per patient microbiological response at TOC (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	243	49
Doripenem	236	75

Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)

Number of patients with a favorable per patient microbiological response at TOC (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	241	45
Doripenem	225	73

Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	304	58	31
Doripenem	296	83	38

Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	37	14
Doripenem	41	22

Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable
CAZ-AVI	35	13
Doripenem	37	20

Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

Intervention	Participants (Number)
	Favorable	Unfavorable	Indeterminate
CAZ-AVI	47	19	9
Doripenem	51	27	6

Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

Intervention	Participants (Number)
	Number of patients with fever (>38°C) at baseline	Number afebrile at the time of the last obs	Number censored at the time of the last obs
CAZ-AVI	123	122	1
Doripenem	118	113	5

Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

Intervention	Participants (Number)
	Number of patients with fever (>38°C) at baseline	Number afebrile at the time of the last obs	Number censored at the time of the last obs
CAZ-AVI	124	124	0
Doripenem	111	108	3

Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

Intervention	Participants (Number)
	Number of patients with fever (>38°C) at baseline	Number afebrile at the time of the last obs	Number censored at the time of the last obs
CAZ-AVI	124	124	0
Doripenem	108	105	3

Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)

Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

Intervention	Participants (Number)
	Number of patients with fever (>38°C) at baseline	Number afebrile at the time of the last obs	Number censored at the time of the last obs
CAZ-AVI	157	155	2
Doripenem	150	143	7

Number of Patients Afebrile at Last Observation in the Clinically Evaluable Analysis Set for Patients Who Have Fever at Study Entry

Intervention	Participants (Number)
CAZ-AVI + Metronidazole	84
Meropenem	72

Plasma Concentrations for Ceftazidime and Avibactam

Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations (NCT01499290)
Timeframe: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug

Intervention	(NG/ML) (Geometric Mean)
CAZ (1)	50823.0
AVI (1)	9229.4
CAZ (2)	40053.1
AVI (2)	7163.9
CAZ (3)	10967.6
AVI (3)	1690.7

Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI + Metronidazole	248	22
Meropenem	278	16

Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI + Metronidazole	244	21
Meropenem	272	15

Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).

The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA. (NCT01499290)
Timeframe: TOC: 28 to 35 days after start of study drug

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI + Metronidazole	337	37	39
Meropenem	349	30	31

Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]).

Intervention	Participants (Number)
	Clinical cure	Clinical failure
CAZ-AVI + Metronidazole	376	34
Meropenem	385	31

Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).

The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. (NCT01499290)
Timeframe: TOC: 28 to 35 days after start of study drug

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI + Metronidazole	429	47	44
Meropenem	444	39	40

Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set

,,,

Intervention	Participants (Number)
	All	Citrobacter freundii complex	Enterobacter aerogenes	Enterobacter cloacae	Escherichia coli	Klebsiella pneumoniae	Morganella morganii	Proteus mirabilis	Serratia marcescens	Alcaligenes faecalis	Comamonas testosteroni	Pseudomonas aeruginosa
CAZ-AVI + Metronidazole	39	1	0	2	19	10	1	2	1	1	1	2
CAZ-AVI + Metronidazole (Denominator)	47	1	0	3	24	13	2	2	1	1	1	2
Meropenem	55	2	1	7	31	9	1	3	0	2	0	4
Meropenem (Denominator)	64	2	1	7	37	13	1	3	0	2	0	4

Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT)

Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. (NCT01499290)
Timeframe: EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU: 42 to 49 days after start of study drug

,,,,,

Intervention	Participants (Number)
	Clinical cure	Clinical failure	Indeterminate
CAZ-AVI + Metronidazole (EOT)	361	30	22
CAZ-AVI + Metronidazole (LFU)	340	38	35
CAZ-AVI + Metronidazole (TOC)	337	37	39
Meropenem (EOT)	379	19	12
Meropenem (LFU)	347	31	32
Meropenem (TOC)	349	30	31

Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set

The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01499290)
Timeframe: TOC: 28 to 35 days after start of study drug

,,,

Intervention	Participants (Number)
	Citrobacter freundii complex	Enterobacter aerogenes	Enterobacter cloacae	Escherichia coli	Klebsiella pneumoniae	Morganella morganii	Proteus mirabilis	Serratia marcescens	Alcaligenes faecalis	Comamonas testosteroni	Pseudomonas aeruginosa
CAZ-AVI + Metronidazole	1	0	2	19	10	1	2	1	1	1	2
CAZ-AVI + Metronidazole (Denominator)	2	0	3	24	13	2	2	1	1	1	2
Meropenem	2	1	7	31	9	1	3	0	2	0	4
Meropenem (Denominator)	2	1	7	37	13	1	3	0	2	0	4

Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.

,,,

Intervention	Participants (Number)
	Citrobacter freundii complex	Enterobacter aerogenes	Enterobacter cloacae	Escherichia coli	Klebsiella oxytoca	Klebsiella pneumoniae	Proteus mirabilis	Pseudomonas aeruginosa	Enterococcus avium	Enterococcus faecalis	Enterococcus faecium	Staphylococcus aureus	Streptococcus anginosus group	Streptococcus bovis group	Streptococcus mitis group	Bacteroides fragilis	Bacteroides ovatus	Bacteroides stercoris	Bacteroides thetaiotaomicron	Bacteroides uniformis	Bacteroides vulgatus	Clostridium perfringens	Eggerthella lenta	Parabacteroides distasonis	Parvimonas micra
CAZ-AVI + Metronidazole	14	4	11	218	14	40	5	30	8	22	13	17	59	2	10	45	17	9	18	4	6	7	5	13	7
CAZ-AVI + Metronidazole (Denominator)	18	5	13	271	18	51	8	35	8	31	16	18	72	3	15	52	22	10	22	7	8	10	5	16	7
Meropenem	9	5	16	249	12	37	7	34	10	23	18	14	50	6	9	38	17	1	21	6	6	4	7	12	8
Meropenem (Denominator)	12	5	19	285	15	49	9	36	15	28	22	14	61	7	11	47	20	1	25	7	9	4	8	13	10

Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set

"Microbiological responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01499290)
Timeframe: Test of Cure: 28 to 35 days after start of study drug

Intervention	Participants (Number)
	Favourable	Unfavourable	indeterminate
CAZ-AVI + Metronidazole	39	7	2
Meropenem	55	1	8

Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set

"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to a surgical review panel (SRP) assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01499290)
Timeframe: EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU 42 to 49 days after start of study drug

,,,,,

Intervention	Participants (Number)
	Favourable response	Unfavourable response	Indeterminate
CAZ-AVI + Metronidazole (EOT)	362	30	21
CAZ-AVI + Metronidazole (LFU)	340	38	35
CAZ-AVI + Metronidazole (TOC)	337	37	39
Meropenem (EOT)	379	19	12
Meropenem (LFU)	347	32	31
Meropenem (TOC)	349	31	30

Plasma Concentrations for Ceftazidime and Avibactam

Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations (NCT01726023)
Timeframe: At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.

Intervention	ng/mL (Geometric Mean)
Ceftazidime(1)	60300.4
Avibactam(1)	10126.9
Ceftazidime(2)	46473.9
Avibactam(2)	7289.3
Ceftazidime(3)	9555.0
Avibactam(3)	1207.2

The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.

Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever. (NCT01726023)
Timeframe: while on study therapy (from Day 1 to Day 14)

Intervention	Days (Median)
Ceftazidime-Avibactam Plus Metronidazole	1
Meropenem	1.5

The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.

Intervention	Days (Median)
Ceftazidime-Avibactam Plus Metronidazole	1
Meropenem	2

Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.

Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42). (NCT01726023)
Timeframe: study duration (from screening to Day 49 LFU visit)

Intervention	Number of patients (Number)
	Any AE	Any SAE	Any AE leading to discontinuation of IP	Any AE of severe intensity	Total number of deaths	Deaths due to disease progression	Any AE with outcome=death
Ceftazidime-Avibactam Plus Metronidazole	82	9	7	5	2	2	0
Meropenem	83	11	3	5	1	0	1

Safety and Tolerability by Incidence: Extent of Exposure.

Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day. (NCT01726023)
Timeframe: study duration (from screening to Day 49 LFU visit)

Intervention	Number of patients (Number)
	1 - 2 days	3 - 4 days	5 -10 days	11 - 14 days	>14 days
Ceftazidime-Avibactam Plus Metronidazole	10	6	175	24	0
Meropenem	5	5	181	26	0

Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.

Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set) (NCT01726023)
Timeframe: study duration (from screening to Day 49 LFU visit)

Intervention	Number of patients (Number)
	Alanine aminotransferase (μkat/L): PCS (High)	Alkaline phosphatase (μkat/L): PCS (Low)	Alkaline phosphatase (μkat/L): PCS (High)	Aspartate aminotransferase (μkat/L): PCS (High)	Bicarbonate (mmol/L) PCS (Low)	Bicarbonate (mmol/L): PCS (High)	Creatinine (μmol/L): PCS (High)	Glucose (non-fasting) (mmol/L): PCS (Low)	Glucose (non-fasting) (mmol/L): PCS (High)	Gamma-glutamyl transferase (μkat/L):PCS (High)	Inorganic phosphorus (mmol/L): PCS (Low)	Inorganic phosphorus (mmol/L): PCS (High)	Potassium (mmol/L): PCS (Low)	Potassium (mmol/L): PCS (High)	Total bilirubin (μmol/L): PCS (High)	Direct bilirubin (μmol/L): PCS (High)
Ceftazidime-Avibactam Plus Metronidazole	3	0	2	4	1	0	0	0	1	2	3	0	9	3	0	1
Meropenem	8	0	3	4	0	0	1	0	1	4	7	0	5	1	1	1

Safety and Tolerability: Clinical Laboratory Evaluation Hematology.

Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set) (NCT01726023)
Timeframe: study duration (from screening to Day 49 LFU visit)

Intervention	Number of patients (Number)
	Platelet count: PCS (Low)	Platelet count: PCS (High)	Red blood cell count: PCS (Low)	Red blood cell count: PCS (High)	White blood cell: PCS (Low)	White blood cell: PCS (High)	Hemoglobin: PCS (Low)	Hemoglobin: PCS (High)	Lymphocytes: PCS (Low)	Lymphocytes: PCS (High)	Neutrophils: PCS (Low)	Neutrophils: PCS (High)	Eosinophils: PCS (High)	Monocytes: PCS (High)	Basophils: PCS (High)	Direct Coombs test:- at Baseline, + post-Baseline	Hematocrit (ratio): PCS (Low)	Hematocrit (ratio): PCS (High)
Ceftazidime-Avibactam Plus Metronidazole	1	5	7	0	1	4	7	0	1	0	4	9	0	0	0	15	5	0
Meropenem	1	4	13	0	1	5	14	0	1	1	2	8	0	0	0	2	8	0

Safety and Tolerability:ECG , QTcB and QTcF Intervals

Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline. (NCT01726023)
Timeframe: EOT visit/any observation on treatment

Intervention	Number of patients (Number)
	Normal to Abnormal: EOT	Normal to Abnormal: Anytime up to EOT	Reaching a value in QT: ≥450 (ms)	Reaching a value in QT: ≥480 (ms)	Reaching a value in QT: ≥500 (ms)	QT: ≥500 and increase from Baseline ≥60(ms)	Increase in QT: ≥30 (ms)	Increase in QT: ≥60 (ms)	Decrease in QT: ≥30 (ms)	Decrease in QT: ≥60 (ms)	Reaching a value in QTcB: ≥450(ms)	Reaching a value in QTcB: ≥480(ms)	Reaching a value in QTcB: ≥500 (ms)	QTcB: ≥500 and increase from Baseline ≥60(ms)	Increase in QTcB: ≥30 (ms)	Increase in QTcB: ≥60 (ms)	Decrease in QTcB: ≥30 (ms)	Decrease in QTcB: ≥60 (ms)	Reaching a value in QTcF: ≥450 (ms)	Reaching a value in QTcF: ≥480 (ms)	Reaching a value in QTcF: ≥500 (ms)	QTcF: ≥500 and increase from Baseline ≥60 (ms)	Increase in QTcF: ≥30 (ms)	Increase in QTcF: ≥60 (ms)	Decrease QTcF: ≥30 (ms)	Decrease QTcF: ≥60 (ms)
Ceftazidime-Avibactam Plus Metronidazole	17	34	9	2	0	0	115	50	24	12	57	13	4	2	21	2	42	6	19	4	1	0	42	4	21	7
Meropenem	14	30	10	1	0	0	114	44	24	4	63	8	2	1	27	1	26	4	18	0	0	0	41	3	19	1

The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.

The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=70, 80)	Klebsiella oxytoca (n=5, 5)	Klebsiella pneumoniae (n=22, 30)	Pseudomonas aeruginosa (n=14, 18)
Ceftazidime-Avibactam Plus Metronidazole	69	5	21	14
Meropenem	78	5	29	16

The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=84, 89)	Klebsiella oxytoca (n=5, 5)	Klebsiella pneumoniae (n=28,35)	Pseudomonas aeruginosa (n=17, 20)	Streptococcus anginosus grou (n=8, 7)	Streptococcus mitis group (n=6, 5)	Enterococcus faecalis (n=6, 6)	Enterococcus faecium (n=4, 7)
Ceftazidime-Avibactam Plus Metronidazole	77	5	22	15	7	6	5	4
Meropenem	86	5	32	17	6	5	5	5

The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=69, 77)	Klebsiella oxytoca (n=5, 5)	Klebsiella pneumoniae (n=22, 29)	Pseudomonas aeruginosa (n=14, 16)
Ceftazidime-Avibactam Plus Metronidazole	68	5	21	14
Meropenem	75	5	28	14

The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=70, 80)	Klebsiella oxytoca (n=5, 5)	Klebsiella pneumoniae (n=22, 30)	Pseudomonas aeruginosa (n=14, 18)
Ceftazidime-Avibactam Plus Metronidazole	64	4	21	13
Meropenem	75	5	28	16

The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=69, 77)	Klebsiella oxytoca (n=5, 5)	Klebsiella pneumoniae (n=22, 29)	Pseudomonas aeruginosa (n=14, 16)
Ceftazidime-Avibactam Plus Metronidazole	63	4	21	13
Meropenem	72	5	27	14

The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=70, 80)	Klebsiella oxytoca (n=5, 5)	Klebsiella pneumoniae (n=22, 30)	Pseudomonas aeruginosa (n=14, 18)
Ceftazidime-Avibactam Plus Metronidazole	65	5	21	13
Meropenem	77	5	29	16

The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=69, 77)	Klebsiella oxytoca (n=5, 5)	Klebsiella pneumoniae (n=22, 29)	Pseudomonas aeruginosa (n=14, 16)
Ceftazidime-Avibactam Plus Metronidazole	64	5	21	13
Meropenem	74	5	28	14

The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=84, 89)	Klebsiella pneumoniae (n=28, 35)	Pseudomonas aeruginosa (n=17, 20)	Klebsiella oxytoca (n=5, 5)	Enterococcus faecalis (n=6, 6)	Enterococcus faecium (n=4, 7)	Streptococcus anginosus group (n=8, 7)	Streptococcus mitis group (n=6, 5)
Ceftazidime-Avibactam Plus Metronidazole	70	22	14	4	4	3	7	6
Meropenem	82	31	17	5	4	5	5	5

The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

Intervention	Participants with favorable responses (Number)
	Escherichia coli (n=84, 89)	Klebsiella oxytoca (n=5, 5)	Klebsiella pneumoniae (n=28,35)	Pseudomonas aeruginosa (n=17, 20)	Streptococcus anginosus group (n=8, 7)	Streptococcus mitis group (n=6, 5)	Enterococcus faecalis (n=6, 6)	Enterococcus faecium (n=4, 7)
Ceftazidime-Avibactam Plus Metronidazole	70	5	23	14	7	6	6	4
Meropenem	84	5	31	17	5	5	4	5

The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.

"The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)

Intervention	Number of patients (Number)
	Favorable	Unfavorable
Ceftazidime-Avibactam Plus Metronidazole	22	1
Meropenem	25	1

The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

Intervention	Number of patients (Number)
	Favorable	Unfavorable	Indeterminate
Ceftazidime-Avibactam Plus Metronidazole	24	1	4
Meropenem	27	1	1

The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.

Intervention	Number of patients (Number)
	Favorable	Unfavorable
Ceftazidime-Avibactam Plus Metronidazole	22	1
Meropenem	23	1

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.

"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)

Intervention	Number of patients (Number)
	Favorable	Unfavorable
Ceftazidime-Avibactam Plus Metronidazole	104	3
Meropenem	120	5

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

Intervention	Number of patients (Number)
	Favorable	Unfavorable	Indeterminate
Ceftazidime-Avibactam Plus Metronidazole	126	6	11
Meropenem	140	7	5

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.

Intervention	Number of patients (Number)
	Favorable	Unfavorable
Ceftazidime-Avibactam Plus Metronidazole	103	3
Meropenem	113	5

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.

"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)

Intervention	Number of patients (Number)
	Favorable	Unfavorable
Ceftazidime-Avibactam Plus Metronidazole	90	7
Meropenem	106	6

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)

Intervention	Number of patients (Number)
	Favorable	Unfavorable	Indeterminate
Ceftazidime-Avibactam Plus Metronidazole	116	10	17
Meropenem	132	9	11

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.

"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)

Intervention	Number of patients (Number)
	Favorable	Unfavorable
Ceftazidime-Avibactam Plus Metronidazole	89	7
Meropenem	100	6

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.

"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)

Intervention	Number of patients (Number)
	Favorable	Unfavorable
Ceftazidime-Avibactam Plus Metronidazole	93	7
Meropenem	113	6

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)

Intervention	Number of patients (Number)
	Favorable	Unfavorable	Indeterminate
Ceftazidime-Avibactam Plus Metronidazole	119	10	14
Meropenem	135	9	8

The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.

"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)

Intervention	Number of patients (Number)
	Favorable	Unfavorable
Ceftazidime-Avibactam Plus Metronidazole	92	7
Meropenem	107	6

The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.

The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	183	7
Meropenem	187	9

The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	104	3
Meropenem	120	5

The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure	Indeterminate
Ceftazidime-Avibactam Plus Metronidazole	126	6	11
Meropenem	140	7	5

The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	103	3
Meropenem	113	5

The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	157	11
Meropenem	168	11

The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	90	7
Meropenem	106	6

The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure	Indeterminate
Ceftazidime-Avibactam Plus Metronidazole	116	10	17
Meropenem	132	9	11

The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	89	7
Meropenem	100	6

The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	166	11
Meropenem	173	11

The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	93	7
Meropenem	113	6

The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure	Indeterminate
Ceftazidime-Avibactam Plus Metronidazole	119	10	14
Meropenem	135	9	8

The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.

Intervention	Number of patients (Number)
	Clinical cure	Clinical failure
Ceftazidime-Avibactam Plus Metronidazole	92	7
Meropenem	107	6

The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population

Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection. (NCT01445678)
Timeframe: TOC; 26-30 days after start of study drug administration

Intervention	percentage of subjects (Number)
CXA-201 and Metronidazole as Treatment for cIAI	83.0
Meropenem as Treatment for cIAI	87.3

The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population

Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection. (NCT01445678)
Timeframe: EOT; Within 24 hours of last study drug administration

Intervention	percentage of subjects (Number)
CXA-201 and Metronidazole as Treatment for cIAI	89.2
Meropenem as Treatment for cIAI	92.3

The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population

Intervention	percentage of subjects (Number)
CXA-201 and Metronidazole as Treatment for cIAI	97.1
Meropenem as Treatment for cIAI	97.5

The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population

Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit (NCT01445678)
Timeframe: LFU; 38 to 45 days after first study drug administration

Intervention	percentage of subjects (Number)
CXA-201 and Metronidazole as Treatment for cIAI	100
Meropenem as Treatment for cIAI	99.3

The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population

Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit. (NCT01445678)
Timeframe: LFU; 38 to 45 days after first study drug administration

Intervention	percentage of subjects (Number)
CXA-201 and Metronidazole as Treatment for cIAI	82.5
Meropenem as Treatment for cIAI	86.6

The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population

Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure) for each baseline pathogen (NCT01445678)
Timeframe: TOC; 26-30 days after start of study drug administration

Intervention	percentage of subjects (Number)
CXA-201 and Metronidazole as Treatment for cIAI	94.2
Meropenem as Treatment for cIAI	94.7

The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population

(NCT01345929)
Timeframe: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)

Intervention	percentage of subjects (Number)
CXA-201 as Treatment for cUTI	76.9
Levofloxacin as Treatment for cUTI	68.4

The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.

(NCT01345929)
Timeframe: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)

Intervention	percentage of subjects (Number)
CXA-201 as Treatment for cUTI	83.3
Levofloxacin as Treatment for cUTI	75.4

Percentage of Participants Discontinuing Study Drug Due to AEs

The percentage of participants withdrawing from study therapy due to an AE was determined. (NCT02739997)
Timeframe: Up to Day 14

Intervention	Percentage of Participants (Number)
MK-7625A + Metronidazole	0.0

Percentage of Participants With Adverse Events (AEs)

The percentage of participants with ≥1 AEs was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. (NCT02739997)
Timeframe: Up to Day 42 (up to 28 days after completing study therapy)

Intervention	Percentage of Participants (Number)
MK-7625A + Metronidazole	62.0

Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at End Of Therapy (EOT)

"The percentage of participants with clinical responses (cure, failure, or indeterminate) at EOT was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure." (NCT02739997)
Timeframe: Up to Day 14

Intervention	Percentage of Participants (Number)
	Success	Failure	Indeterminate
MK-7625A + Metronidazole	94.6	5.4	0.0

Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Late Follow-Up (LFU)

"The percentage of participants with clinical responses (cure, failure, or indeterminate) at LFU was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure." (NCT02739997)
Timeframe: Up to Day 42 (28 days after completing study therapy)

Intervention	Percentage of Participants (Number)
	Success	Failure	Indeterminate
MK-7625A + Metronidazole	90.6	9.4	0.0

Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Test of Cure (TOC)

"The percentage of participants with clinical responses (cure, failure, or indeterminate) at TOC was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure." (NCT02739997)
Timeframe: Day 28 (28 days after initiating study therapy)

Intervention	Percentage of Participants (Number)
	Success	Failure	Indeterminate
MK-7625A + Metronidazole	92.0	8.0	0.0

Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at EOT

"The percentage of participants with microbiological responses (eradication, persistence, or indeterminate) at EOT was determined. Eradication was defined as absence of the baseline pathogen in a specimen. Persistence was defined as presence of the baseline pathogen in a specimen. Indeterminate was defined as Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response." (NCT02739997)
Timeframe: Up to Day 14

Intervention	Percentage of Participants (Number)
	Eradication	Persistence	Indeterminate
MK-7625A + Metronidazole	93.8	6.2	0.0

Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at TOC

"The percentage of participants with microbiological response (eradication, persistence, or indeterminate) at TOC was determined. Eradication was defined as absence of the baseline pathogen in a specimen. Persistence was defined as presence of the baseline pathogen in a specimen. Indeterminate was defined as Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response." (NCT02739997)
Timeframe: Day 28 (28 days after initiating study therapy)

Intervention	Percentage of Participants (Number)
	Eradication	Persistence	Indeterminate
MK-7625A + Metronidazole	90.2	9.8	0.0

Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at EOT

The percentage of participants with per-pathogen microbiological responses at EOT was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown. (NCT02739997)
Timeframe: Up to Day 14

Intervention	Percentage of Participants (Number)
	Gram-Negative Aerobes	Gram-Positive Aerobes	Gram-Negative Anaerobes	Gram-Positive Anaerobes
MK-7625A + Metronidazole	94.5	95.0	97.7	90.5

Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at TOC

The percentage of participants with per-pathogen microbiological responses at TOC was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown. (NCT02739997)
Timeframe: Day 28 (28 days after initiating study therapy)

Intervention	Percentage of Participants (Number)
	Gram-Negative Aerobes	Gram-Positive Aerobes	Gram-Negative Anaerobes	Gram-Positive Anaerobes
MK-7625A + Metronidazole	90.6	89.5	95.2	85.0

Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Population

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). (NCT02475733)
Timeframe: LFU visit (up to a maximum study duration of 50 days)

Intervention	percentage of participants (Number)
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole	0
Meropenem	0

Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Population

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). (NCT02475733)
Timeframe: LFU visit (up to a maximum study duration of 50 days)

Intervention	percentage of participants (Number)
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole	0
Meropenem	0

Percentage of Participants With Emergent Infections at Test of Cure (TOC) Visit: Microbiologically Evaluable Population

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. (NCT02475733)
Timeframe: TOC visit (up to a maximum study duration of 50 days)

Intervention	percentage of participants (Number)
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole	0
Meropenem	0

Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population

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. (NCT02475733)
Timeframe: Baseline up to 50 days

Intervention	percentage of participants (Number)
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole	0
Meropenem	0

Percentage of Participants With Favorable Clinical Response (CR) at End of 72 Hours Treatment: Intent-to-treat (ITT) Analysis Population

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. (NCT02475733)
Timeframe: End of 72 hours study drug treatment on Day 1

Intervention	percentage of participants (Number)
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole	93.4
Meropenem	90.9

Percentage of Participants With Favorable Clinical Response (CR) at End of Intravenous Therapy (EOIV) Visit: Intent-to-treat (ITT) Analysis Population

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. (NCT02475733)
Timeframe: EOIV visit (anytime from Day 4 up to 16)

Intervention	percentage of participants (Number)
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole	96.7
Meropenem	100

Percentage of Participants With Favorable Clinical Response (CR) at End of Treatment (EOT) Visit: Intent-to-treat (ITT) Analysis Population

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). (NCT02475733)
Timeframe: EOT visit (up to Day 17)

Intervention	percentage of participants (Number)
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole	91.8
Meropenem	100

Percentage of Participants With Favorable Clinical Response (CR) at Test of Cure (TOC) Visit: Intent-to-treat (ITT) Analysis Population

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). (NCT02475733)
Timeframe: TOC visit (up to a maximum study duration of 50 days)

Intervention	percentage of participants (Number)
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole	91.8
Meropenem	95.5