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Trial record 6 of 9 for:    ACHN-490 OR Plazomicin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01096849
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Achaogen, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Complicated Urinary Tract Infection
Acute Pyelonephritis
Interventions Drug: levofloxacin
Drug: plazomicin
Drug: placebo
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo. Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.
Period Title: Overall Study
Started 22 76 47
Completed 20 64 41
Not Completed 2 12 6
Reason Not Completed
Consent Withdrawn             1             4             2
Lack of Efficacy             0             2             0
Unacceptable/ Intolerable AE(s)             0             1             1
Investigator or Medical Monitor Decision             0             1             0
Administrative Reasons             0             1             2
Lost to Follow-up             1             3             1
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin Total
Hide Arm/Group Description Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo. Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin. Total of all reporting groups
Overall Number of Baseline Participants 22 76 47 145
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population was defined as all randomized patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 76 participants 47 participants 145 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  77.3%
72
  94.7%
42
  89.4%
131
  90.3%
>=65 years
5
  22.7%
4
   5.3%
5
  10.6%
14
   9.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 76 participants 47 participants 145 participants
46.5  (18.12) 40.00  (15.02) 44.8  (14.61) 42.6  (15.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 76 participants 47 participants 145 participants
Female
18
  81.8%
61
  80.3%
37
  78.7%
116
  80.0%
Male
4
  18.2%
15
  19.7%
10
  21.3%
29
  20.0%
1.Primary Outcome
Title Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 12 51 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
50
(21.1 to 78.9)
60.8
(46.1 to 74.2)
58.6
(38.9 to 76.5)
2.Primary Outcome
Title Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population was defined as clinically evaluable (CE) patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 7 35 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
85.7
(42.1 to 99.6)
88.6
(73.3 to 96.8)
81.0
(58.1 to 94.6)
3.Primary Outcome
Title Percentage of Patients With Treatment-Emergent Adverse Events (TEAE)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population was defined as all randomized patients who received any amount of study drug.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 22 74 44
Measure Type: Number
Unit of Measure: percentage of patients
31.8 35.1 47.7
4.Secondary Outcome
Title Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population
Hide Description

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.

Time Frame Day 1 to TOC (Day 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was defined as all randomized patients.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 22 76 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
Investigator's Assessment: Cured
63.6
(40.7 to 82.8)
69.7
(58.1 to 79.8)
70.2
(55.1 to 82.7)
Sponsor's Assessment: Cured
59.1
(36.4 to 79.3)
69.7
(58.1 to 79.8)
68.1
(52.9 to 80.9)
5.Secondary Outcome
Title Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 18 64 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
Investigator's Assessment: Cured
66.7
(41.0 to 86.7)
76.6
(64.3 to 86.2)
78.6
(63.2 to 89.7)
Sponsor's Assessment: Cured
66.7
(41.0 to 86.7)
76.6
(64.3 to 86.2)
76.2
(60.5 to 87.9)
6.Secondary Outcome
Title Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 18 64 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
Investigator's Assessment: Cured
94.4
(72.7 to 99.9)
82.8
(71.3 to 91.1)
88.1
(74.4 to 96.0)
Sponsor's Assessment: Cured
94.4
(72.7 to 99.9)
82.8
(71.3 to 91.1)
85.7
(71.5 to 94.6)
7.Secondary Outcome
Title Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 7 35 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
85.7
(42.1 to 99.6)
82.9
(66.4 to 93.4)
76.2
(52.8 to 91.8)
8.Secondary Outcome
Title Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 12 51 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
83.3
(51.6 to 97.9)
74.5
(60.4 to 85.7)
72.4
(52.8 to 87.3)
9.Secondary Outcome
Title Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 7 35 21
Measure Type: Number
Unit of Measure: percentage of patients
Gram-positive bacteria (aerobes), eradication 100 100 100
Gram-negative bacteria (aerobes), eradication 83.3 87.5 80.0
10.Secondary Outcome
Title Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 7 35 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
Acute pyelonephritis, eradication Number Analyzed 2 participants 18 participants 15 participants
100
(15.8 to 100.0)
88.9
(65.3 to 98.6)
80
(51.9 to 95.7)
Complicated Lower UTI, eradication Number Analyzed 5 participants 17 participants 6 participants
80.0
(28.4 to 99.5)
88.2
(63.6 to 98.5)
83.3
(35.9 to 99.6)
cUTI with indwelling catheter, eradication Number Analyzed 1 participants 4 participants 0 participants
0
(0 to 97.5)
75
(19.4 to 99.4)
cUTI without indwelling catheter, eradication Number Analyzed 4 participants 13 participants 6 participants
100
(39.8 to 100.0)
92.3
(64.0 to 99.8)
83.3
(35.9 to 99.6)
11.Secondary Outcome
Title Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 7 35 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
India, eradicaton Number Analyzed 3 participants 6 participants 3 participants
66.7
(9.4 to 99.2)
66.7
(22.3 to 95.7)
0
(0 to 70.8)
Latin America, eradication Number Analyzed 2 participants 11 participants 8 participants
100
(15.8 to 100)
100
(71.5 to 100)
100
(63.1 to 100)
North America, eradication Number Analyzed 2 participants 18 participants 10 participants
100
(15.8 to 100)
88.9
(65.3 to 98.6)
90
(55.5 to 99.7)
12.Secondary Outcome
Title Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 12 51 29
Mean (Standard Error)
Unit of Measure: days
11.8  (2.67) 10.7  (1.93) 13.3  (3.16)
13.Secondary Outcome
Title Time (Days) to Clinical Cure Based on Investigator’s and Sponsor’s Assessments in the MITT Population
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 12 51 29
Mean (Standard Error)
Unit of Measure: days
Investigator's Assessment Number Analyzed 8 participants 39 participants 20 participants
9.5  (2.43) 7.0  (0.71) 7.6  (0.82)
Sponsor's Assessment Number Analyzed 8 participants 39 participants 19 participants
9.5  (2.43) 7.0  (0.71) 7.4  (0.83)
14.Secondary Outcome
Title Time (Days) to Defervescense in the MITT Population
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 1 9 3
Mean (Standard Error)
Unit of Measure: days
1.0 2.1  (0.26) 2.0  (0.58)
15.Secondary Outcome
Title Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 7 35 21
Measure Type: Number
Unit of Measure: percentage of patients
Clinical Relapse 0 14.3 6.3
Microbiological Recurrence 0 6.5 23.5
16.Secondary Outcome
Title Percentage of Patients With a Superinfection or New Infection in the ME Population
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description:
Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
Overall Number of Participants Analyzed 7 35 21
Measure Type: Number
Unit of Measure: percentage of patients
Superinfection 28.6 8.6 0
New infection 0 2.9 4.8
Time Frame Day 1 to the end of the study (Day 40)
Adverse Event Reporting Description The safety population, all randomized patients who received any amount of study drug.
 
Arm/Group Title Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Hide Arm/Group Description Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo. Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin.
All-Cause Mortality
Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/74 (0.00%)   0/44 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   1/74 (1.35%)   2/44 (4.55%) 
Infections and infestations       
Pyelonephritis acute  1  0/22 (0.00%)  0/74 (0.00%)  1/44 (2.27%) 
Nervous system disorders       
Convulsion  1  0/22 (0.00%)  0/74 (0.00%)  1/44 (2.27%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/22 (0.00%)  1/74 (1.35%)  0/44 (0.00%) 
1
Term from vocabulary, MedDRA (12.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Plazomicin (10 mg/kg) Plazomicin (15 mg/kg) Levofloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/22 (9.09%)   22/74 (29.73%)   3/44 (6.82%) 
Gastrointestinal disorders       
Diarrhoea  1  0/22 (0.00%)  4/74 (5.41%)  2/44 (4.55%) 
Nausea  1  0/22 (0.00%)  4/74 (5.41%)  0/44 (0.00%) 
Vomiting  1  0/22 (0.00%)  4/74 (5.41%)  1/44 (2.27%) 
Nervous system disorders       
Headache  1  2/22 (9.09%)  6/74 (8.11%)  3/44 (6.82%) 
Dizziness  1  0/22 (0.00%)  4/74 (5.41%)  0/44 (0.00%) 
1
Term from vocabulary, MedDRA (12.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Investigator may publish/present the study results provided all of the following: (i) the primary publication has been published; or, if no such publication has occurred, at least 18m have passed since the completion of the study; (ii) Achaogen is allowed at least 60d to review; (iii) confidential information is deleted as requested; (iv) comments and proposed revisions are considered; and (v) during the 60d review, if requested, the Investigator shall delay the publication or presentation.
Results Point of Contact
Name/Title: Clinical Trials Posting Group
Organization: Achaogen, Inc.
Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT01096849     History of Changes
Other Study ID Numbers: ACHN-490-002
First Submitted: March 12, 2010
First Posted: March 31, 2010
Results First Submitted: July 24, 2018
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018