Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Number of Patients With Treatment-Emergent Adverse Events |
Percent of participants experiencing Treatment Emergent Adverse Events (TEAE). Treatment emergent is defined as any event that starts or worsens during or after treatment. |
Study Days 1 to 35 |
|
| Other |
Number of Patients With Serious Adverse Events |
Percent of participants experiencing treatment emergent Serious Adverse Events (SAE). |
Study Days 1 to 35 |
|
| Primary |
Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Microbiologic Success at Test of Cure (TOC) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Clinical Success at Test of Cure (TOC) in the microITT Population |
Symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Composite Success at End of Treatment (EOT) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Microbiological Success at End of Treatment (EOT) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Clinical Success at End of Treatment (EOT) in the microITT Population |
Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Composite Success at Late Follow Up (LFU) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Microbiological Success at Late Follow Up (LFU) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Clinical Success at Late Follow Up (LFU) in the microITT Population |
Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population |
The proportion of patients with clinical success based on investigator opinion at TOC. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population |
Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population |
Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population |
Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Composite Success at End of Treatment (EOT) in the Microbiologically-Evaluable (ME) Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Microbiologic Success at End of Treatment (EOT) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Composite Success at Test of Cure (TOC) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Microbiologic Success at Test of Cure (TOC) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Composite Success at Late Follow Up (LFU) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Microbiologic Success at Late Follow Up (LFU) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population |
Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (=10^5 CFU/mL) is eradicated to <10^3 CFU/mL. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Clinical Success at End of Treatment (EOT) in the Clinically Evaluable (CE) Population |
Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Clinical Success at Test of Cure (TOC) in the CE Population |
Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Clinical Success at Late Follow Up (LFU) in the CE Population |
Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population |
Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population |
Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population |
Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population |
Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population |
Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population |
Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population |
Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population |
Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population |
Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population |
Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population |
Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population |
Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population |
Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population |
Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) |
|
| Secondary |
Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population |
Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated. |
Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) |
|
