Trial Outcomes & Findings for Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam (NCT NCT03485950)

Last Updated: 2022-03-15

Results Overview

Resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required (ie, except for protocol-allowed adjunctive therapies and/or oral or IV switch) and such that no more than 14 days of total antibacterial therapy is required.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Within 72 hours after administration of the last dose of inpatient IV study drug

Results posted on

2022-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Ceftolozane/Tazobactam Arm Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.	Standard of Care (SOC) Arm Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.
Overall Study STARTED	50	50
Overall Study COMPLETED	43	48
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ceftolozane/Tazobactam Arm Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.	Standard of Care (SOC) Arm Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.
Overall Study Adverse Event	1	0
Overall Study Death	3	2
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceftolozane/Tazobactam Arm n=47 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.	Standard of Care (SOC) Arm n=50 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Total n=97 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	55 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Middle East	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	32 Participants n=5 Participants	35 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Others	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	50 participants n=7 Participants	97 participants n=5 Participants
Type of Hematological malignancy Acute Lymphocytic Leukemia(ALL)	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Type of Hematological malignancy Chronic Lymphocytic Leukemia (AML)	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Type of Hematological malignancy Chronic Myeloid Leukemia (CML)	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Type of Hematological malignancy Lymphoma	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Type of Hematological malignancy Others	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
History of Bone Marrow Transplant (BMT) within 1 year Autologous	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
History of Bone Marrow Transplant (BMT) within 1 year Allogeneic	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Temperature at initial presentation < 36 Celsius	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Temperature at initial presentation 36 -38 Celsius	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Temperature at initial presentation >38 Celsius	44 Participants n=5 Participants	43 Participants n=7 Participants	87 Participants n=5 Participants
Site of Microorganisms Genitourinary	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Site of Microorganisms Blood	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Organism of positive culture Entereococcus faecalis	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Organism of positive culture E. coli	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Organism of positive culture Klebsiella pneumoniae	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Organism of positive culture Methicillin-resistant Staphylococcus aureus (MRSA)	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Organism of positive culture Pseudomonas aeruginosa	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Organism of positive culture Rothia mucilaginous	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Organism of positive culture Streptococcus viridans	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Organism of positive culture Staphylococcus epidermidis	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Organism of positive culture Entereococcus faecalis + E coli	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Organism of positive culture Enterococcus faecalis + Pseudomonas aeruginosa	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Temperature at baseline	37.3 Celsius n=5 Participants	37.5 Celsius n=7 Participants	37.4 Celsius n=5 Participants
Microbiology Documentation Genitourinary	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Microbiology Documentation Blood	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Microbiology Documentation Genitourinary and Blood	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Bacterial Pathogen Causing Documented Infection Gram Negative	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Bacterial Pathogen Causing Documented Infection Gram Negative and Gram Positive	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Bacterial Pathogen Causing Documented Infection Gram Positive	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 72 hours after administration of the last dose of inpatient IV study drug

Population: Patients in MITT (Modified Intent-To-Treat) Analysis Set

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=50 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=47 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)	36 Participants	41 Participants

SECONDARY outcome

Timeframe: Within 72 hours after administration of the last dose of inpatient IV study drug.

Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set at EOIV.	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Within 72 hours after administration of the last dose of inpatient IV study drug.

Population: Patients in CE (Clinically Evaluable) Analysis Set

The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=38 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=31 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the Clinically Evaluable (CE) Analysis Set at EOIV.	32 Participants	29 Participants

SECONDARY outcome

Timeframe: 21 to 28 days after the start of inpatient IV study drug

Population: Patients in the MITT (Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=50 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=47 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the MITT Analysis Set at TOC	28 Participants	34 Participants

SECONDARY outcome

Timeframe: 35 to 42 days after the start of inpatient IV study drug

Population: Patients in the MITT (Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=50 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=47 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU)	26 Participants	33 Participants

SECONDARY outcome

Timeframe: 21 to 28 days after the start of inpatient IV study drug.

Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Test of Cure (TOC)	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 35 to 42 days after the start of inpatient IV study drug

Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is favorable clinical response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the mMITT Analysis Set at Late Follow-Up (LFU)	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 21 to 28 days after the start of inpatient IV study drug

Population: Patients in CE (Clinically Evaluable) Analysis Set

The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=38 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=31 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the CE Analysis Set at TOC	26 Participants	28 Participants

SECONDARY outcome

Timeframe: 35 to 42 days after the start of inpatient IV study drug

Population: Patients in CE (Clinically Evaluable) Analysis Set

The secondary efficacy outcome is favorable clinical response of the patients in the CE (Clinically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=38 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=31 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the CE Analysis Set at LFU.	24 Participants	27 Participants

SECONDARY outcome

Timeframe: Within 72 hours after administration of the last dose of inpatient IV study drug.

Population: Patients in CE analysis set with baseline Gram-negative pathogen (= ME (Microbiologically Evaluable) Analysis Set)

The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=1 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=2 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV.	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 21 to 28 days after the start of inpatient IV study drug.

Population: Patients in CE analysis set with baseline Gram-negative pathogen (= ME (Microbiologically Evaluable) Analysis Set)

The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=1 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=2 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the ME Analysis Set at TOC	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 35 to 42 days after the start of inpatient IV study drug

Population: Patients in CE analysis set with baseline Gram-negative pathogen (= ME (Microbiologically Evaluable) Analysis Set)

The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=1 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=2 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Clinical Response in the ME Analysis Set at LFU.	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 72 hours after administration of the last dose of inpatient IV study drug

Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at EOIV.	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 21 to 28 days after the start of inpatient IV study drug

Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Favorable Microbiological Response in the mMITT Analysis Set at TOC.	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 35 to 42 days after the start of inpatient IV study drug.

Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is favorable microbiological response of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Microbiological Response in the mMITT Analysis Set at LFU.	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Within 72 hours after administration of the last dose of inpatient IV study drug

Population: Patients in ME (Microbiologically Evaluable) Analysis Set

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=1 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=2 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Microbiological Response in the ME Analysis Set at EOIV.	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 21 to 28 days after the start of inpatient IV study drug

Population: Patients in ME (Microbiologically Evaluable) Analysis Set.

The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at test-of-cure (TOC). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=1 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=2 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Microbiological Response in the ME Analysis Set at TOC.	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 35 to 42 days after the start of inpatient IV study drug

The secondary efficacy outcome is favorable microbiological response of the patients in the ME (Microbiologically Evaluable) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=1 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=2 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Favorable Microbiological Response in the ME Analysis Set at LFU	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 21 to 28 days after the start of inpatient IV study drug

Population: Patients in MITT (Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC).

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=50 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=47 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Infection-related Mortality in the MITT Analysis Set at TOC	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 35 to 42 days after the start of inpatient IV study drug

Population: Patients in MITT (Modified Intent-to-Treat) Analysis Set

The secondary efficacy outcome is infection-related mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU).

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=50 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=47 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Infection-related Mortality in the MITT Analysis Set at LFU	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 21 to 28 days after the start of inpatient IV study drug

Population: Patients in mMITT (Microbiological Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at test-of-cure (TOC).

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Infection-related Mortality the mMITT Analysis Set at TOC	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 35 to 42 days after the start of inpatient IV study drug

The secondary efficacy outcome is infection-related mortality of the patients in the mMITT (Microbiological Modified Intent-To-Treat) Analysis Set at late follow-up (LFU).

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
Number of Participants With Infection-related Mortality in the mMITT Analysis Set at LFU.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after the last dose of inpatient IV study drug

Population: Patients in MITT (Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is all-cause mortality of the patients in the MITT (Modified Intent-To-Treat) Analysis Set, which is mortality within 30 days after the last dose of inpatient IV study drug.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=50 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=47 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
30 Day All-cause Mortality in the MITT Analysis Set	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days after the last dose of inpatient IV study drug

Population: Patients in mMITT (Modified Intent-To-Treat) Analysis Set

The secondary efficacy outcome is all-cause mortality of the patients in the mMITT (microbiological Modified Intent-To-Treat) Analysis Set, which is mortality within 30 days after the last dose of inpatient IV study drug.

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) Arm n=2 Participants Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.	Ceftolozane/Tazobactam Arm n=4 Participants Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.
30 Day All-cause Mortality in the mMITT Analysis Set	0 Participants	0 Participants

Adverse Events

Ceftolozane/Tazobactam Arm

Serious events: 33 serious events

Other events: 9 other events

Deaths: 3 deaths

Standard of Care (SOC) Arm

Serious events: 33 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ceftolozane/Tazobactam Arm n=47 participants at risk Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy.	Standard of Care (SOC) Arm n=50 participants at risk Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy.
Hepatobiliary disorders ALT elevation	6.4% 3/47 • From the date of the first dose of IV study drug to 30 days following the last dose of study drug. All patients were followed until last follow up which occurred 35-42 days following the first dose of study drug.	6.0% 3/50 • From the date of the first dose of IV study drug to 30 days following the last dose of study drug. All patients were followed until last follow up which occurred 35-42 days following the first dose of study drug.
Skin and subcutaneous tissue disorders Rash	8.5% 4/47 • From the date of the first dose of IV study drug to 30 days following the last dose of study drug. All patients were followed until last follow up which occurred 35-42 days following the first dose of study drug.	6.0% 3/50 • From the date of the first dose of IV study drug to 30 days following the last dose of study drug. All patients were followed until last follow up which occurred 35-42 days following the first dose of study drug.
Infections and infestations Urinary tract infection	6.4% 3/47 • From the date of the first dose of IV study drug to 30 days following the last dose of study drug. All patients were followed until last follow up which occurred 35-42 days following the first dose of study drug.	0.00% 0/50 • From the date of the first dose of IV study drug to 30 days following the last dose of study drug. All patients were followed until last follow up which occurred 35-42 days following the first dose of study drug.

Additional Information

Issam Raad,MD - Chair, Infectious Diseases

UT MD Anderson Cancer Center

Phone: (713) 792-7943

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place