A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)

Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at ≥10\^5 colony forming units per milliliter (CFU/mL) was reduced to \<10\^4 CFU/mL. Clinical Cure at Day 5: marked improvement evidenced by complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms developed. Failure: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; adverse event (AE) requiring the discontinuation of study drug and the patient required alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow an evaluation of clinical outcome for any reason.

Time frame: Day 5

Population: The mMITT Population consisted of all patients in the ITT Population who received any amount of study drug and had at least one qualified baseline pathogen from a study qualifying baseline urine culture against which meropenem and plazomicin have antibacterial activity.

Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at ≥10\^5 CFU/mL was reduced to \<10\^4 CFU/mL. Clinical Cure at TOC Visit: the complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow an evaluation of clinical outcome for any reason.

Time frame: Day 17 TOC Visit

Population: The mMITT Population consisted of all patients in the ITT Population who received any amount of study drug and had at least one qualified baseline pathogen from a study qualifying baseline urine culture against which meropenem and plazomicin have antibacterial activity.

Microbiological eradication: urine culture showed the pathogen found at baseline at ≥10\^5 CFU/mL was reduced to \<10\^4 CFU/mL. Clinical Cure Day 5: Marked improvement defined as complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms develop. Failure Day 5: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; AE requiring the discontinuation of study drug and the patient required alternative non-study antibiotic therapy for the current cUTI.

Time frame: Day 5

Population: The ME (Day 5) population consists of clinically evaluable patients with interpretable culture results at Day 5, defined as one that has clearly identified pathogen(s) or one where baseline pathogen(s) could be excluded.

Microbiological eradication: urine culture showed the pathogen found at baseline at ≥10\^5 CFU/mL was reduced to \<10\^4 CFU/mL. Clinical Cure TOC: Complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure TOC: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI.

Time frame: Day 17 TOC Visit

Population: The ME (TOC) population consists of clinically evaluable patients with interpretable culture results at TOC, defined as one that has clearly identified pathogen(s) or one where baseline pathogen(s) could be excluded.

An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.

Time frame: Up to Day 32

Population: The safety population included all randomized patients who received any amount of study drug.

PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.

Time frame: Day 3

Population: The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.

PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.

Time frame: Day 3

Population: The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.

PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.

Time frame: Day 3

Population: The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.