This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
145
Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10\^5 colony forming unit(s) per milliliter (CFU/mL) were reduced to \<10\^4 CFU/mL.
Time frame: Day 1 to TOC (Day 12)
Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10\^5 CFU/mL were reduced to \<10\^4 CFU/mL.
Time frame: Day 1 to TOC (Day 12)
Percentage of Patients With Treatment-Emergent Adverse Events (TEAE)
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: Day 1 to the end of study (Day 40)
Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population
Investigator's assessment criteria defined Clinical Cure as resolution of baseline clinical signs and symptoms of infection through the TOC visit. The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered.
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Time frame: Day 1 to TOC (Day 12)
Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population
Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit. The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered.
Time frame: Day 1 to TOC (Day 12)
Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population
Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the EOT visit. The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered.
Time frame: Day 1 to EOT (Day 5)
Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10\^5 CFU/mL were reduced to \<10\^4 CFU/mL.
Time frame: Day 1 to EOT (Day 5)
Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10\^5 CFU/mL were reduced to \<10\^4 CFU/mL.
Time frame: Day 1 to EOT (Day 5)
Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10\^5 CFU/mL were reduced to \<10\^4 CFU/mL.
Time frame: Day 1 to TOC (Day 12)
Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10\^5 CFU/mL were reduced to \<10\^4 CFU/mL.
Time frame: Day 1 to TOC (Day 12)
Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region
MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10\^5 CFU/mL were reduced to \<10\^4 CFU/mL.
Time frame: Day 1 to TOC (Day 12)
Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population
Resolution of clinical signs and symptoms is defined as absence of all signs and symptoms present at baseline.
Time frame: Day 1 to End of Study (Day 40)
Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population
Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit. The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered.
Time frame: Day 1 to End of Study (Day 40)
Time (Days) to Defervescense in the MITT Population
Defervescence is defined as the absence of fever \<37.7 degrees Celsius and is assessed in patients who were afebrile at baseline.
Time frame: Day 1 to End of Study (Day 40)
Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population
Patients who had a clinical relapse (defined as the return of clinical signs and symptoms requiring antibiotic therapy) or microbiological recurrence (defined as eradication of the original pathogen\[s\] at the TOC visit but regrowth at the level \>10\^5 CFU/mL by the LTFU \[long term follow up\] visit).
Time frame: Day 1 to LTFU (Day 40)
Percentage of Patients With a Superinfection or New Infection in the ME Population
Superinfections are defined as a pathogen other than the one at baseline found in urine at ≥10\^5 CFU/mL any time after the first infusion through EOT. New infections are defined as a pathogen other than the one at baseline found in urine at ≥10\^5 CFU/mL any time after EOT.
Time frame: Day 1 to to End of Study (Day 40)