Trial · NCT01096849
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
NCT01096849, Phase 2, Completed, Achaogen, Inc.; results first posted 2018-08-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP). Trials, record NCT01096849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01096849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
- NCT number
- NCT01096849
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 145 participants, actual
- Lead sponsor
- Achaogen, Inc.
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis
- Interventions
- levofloxacin, plazomicin, placebo
- First posted
- 2010-03-31
- Last updated
- 2018-08-22
- Results first posted
- 2018-08-22
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | Day 1 to TOC (Day 12) | 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. |
| Primary | Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | Day 1 to TOC (Day 12) | 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. |
| Primary | Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | Day 1 to the end of study (Day 40) | 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. |
| Secondary | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population | Day 1 to TOC (Day 12) | 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. |
| Secondary | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population | Day 1 to TOC (Day 12) | 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. |
| Secondary | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population | Day 1 to EOT (Day 5) | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population | Day 1 to EOT (Day 5) | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population | Day 1 to EOT (Day 5) | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen | Day 1 to TOC (Day 12) | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category | Day 1 to TOC (Day 12) | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | Day 1 to TOC (Day 12) | 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. | percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | Day 1 to TOC (Day 12) | 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. | percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | Day 1 to the end of study (Day 40) | The Safety population was defined as all randomized patients who received any amount of study drug. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population | Day 1 to TOC (Day 12) | The intent-to-treat (ITT) population was defined as all randomized patients. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population | Day 1 to TOC (Day 12) | 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. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population | Day 1 to EOT (Day 5) | 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. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population | Day 1 to EOT (Day 5) | 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. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population | Day 1 to EOT (Day 5) | 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. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen | Day 1 to TOC (Day 12) | 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. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category | Day 1 to TOC (Day 12) | 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. | percentage of patients | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group83
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | Plazomicin (10 mg/kg) | 50 | 95% Confidence Interval 21.1 to 78.9 | percentage of patients | |
| Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | Plazomicin (15 mg/kg) | 60.8 | 95% Confidence Interval 46.1 to 74.2 | percentage of patients | |
| Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | Levofloxacin | 58.6 | 95% Confidence Interval 38.9 to 76.5 | percentage of patients | |
| Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | Plazomicin (10 mg/kg) | 85.7 | 95% Confidence Interval 42.1 to 99.6 | percentage of patients | |
| Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | Plazomicin (15 mg/kg) | 88.6 | 95% Confidence Interval 73.3 to 96.8 | percentage of patients | |
| Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | Levofloxacin | 81.0 | 95% Confidence Interval 58.1 to 94.6 | percentage of patients | |
| Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | Plazomicin (10 mg/kg) | 31.8 | percentage of patients | ||
| Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | Plazomicin (15 mg/kg) | 35.1 | percentage of patients | ||
| Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | Levofloxacin | 47.7 | percentage of patients | ||
| Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population | Plazomicin (10 mg/kg) | Investigator's Assessment: Cured | 63.6 | 95% Confidence Interval 40.7 to 82.8 | percentage of patients |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Plazomicin (10 mg/kg) | 22 | |
| Overall Study | STARTED | Plazomicin (15 mg/kg) | 76 | |
| Overall Study | STARTED | Levofloxacin | 47 | |
| Overall Study | COMPLETED | Plazomicin (10 mg/kg) | 20 | |
| Overall Study | COMPLETED | Plazomicin (15 mg/kg) | 64 | |
| Overall Study | COMPLETED | Levofloxacin | 41 | |
| Overall Study | NOT COMPLETED | Plazomicin (10 mg/kg) | 2 | |
| Overall Study | NOT COMPLETED | Plazomicin (15 mg/kg) | 12 | |
| Overall Study | NOT COMPLETED | Levofloxacin | 6 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Plazomicin (10 mg/kg) | 0 | 22 | |
| other | Diarrhoea | Gastrointestinal disorders | Plazomicin (15 mg/kg) | 4 | 74 | |
| other | Diarrhoea | Gastrointestinal disorders | Levofloxacin | 2 | 44 | |
| other | Nausea | Gastrointestinal disorders | Plazomicin (10 mg/kg) | 0 | 22 | |
| other | Nausea | Gastrointestinal disorders | Plazomicin (15 mg/kg) | 4 | 74 | |
| other | Nausea | Gastrointestinal disorders | Levofloxacin | 0 | 44 | |
| other | Vomiting | Gastrointestinal disorders | Plazomicin (10 mg/kg) | 0 | 22 | |
| other | Vomiting | Gastrointestinal disorders | Plazomicin (15 mg/kg) | 4 | 74 | |
| other | Vomiting | Gastrointestinal disorders | Levofloxacin | 1 | 44 | |
| other | Headache | Nervous system disorders | Plazomicin (10 mg/kg) | 2 | 22 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Plazomicin (10 mg/kg) | 0 | 22 |
| Total, all-cause mortality | Plazomicin (15 mg/kg) | 0 | 74 |
| Total, all-cause mortality | Levofloxacin | 0 | 44 |
| Total, other adverse events | Plazomicin (10 mg/kg) | 2 | 22 |
| Total, other adverse events | Plazomicin (15 mg/kg) | 22 | 74 |
| Total, other adverse events | Levofloxacin | 3 | 44 |
| Total, serious adverse events | Plazomicin (10 mg/kg) | 0 | 22 |
| Total, serious adverse events | Plazomicin (15 mg/kg) | 1 | 74 |
| Total, serious adverse events | Levofloxacin | 2 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29378708 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01096849
GET https://conductscience.org/api/trials/v1/NCT01096849/results?page=2