Trial · NCT02486627
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
NCT02486627, Phase 3, Completed, Achaogen, Inc.; results first posted 2018-08-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP). Trials, record NCT02486627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02486627
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
- NCT number
- NCT02486627
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 609 participants, actual
- Lead sponsor
- Achaogen, Inc.
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis
- Interventions
- plazomicin, meropenem, levofloxacin (oral)
- First posted
- 2015-07-01
- Last updated
- 2018-08-23
- Other registries' IDs
- eudract:2015-001588-37
- Results first posted
- 2018-08-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 | Day 5 | 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. |
| Primary | Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC) | Day 17 TOC Visit | 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. |
| Secondary | Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at Day 5 | Day 5 | 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. |
| Secondary | Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at TOC | Day 17 TOC Visit | 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. |
| Secondary | Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 32 | 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 | Plasma Pharmacokinetics (PK): Area Under the Curve From 0 to 24 Hours (AUC 0-24h) | Day 3 | 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. |
| Secondary | Plasma PK: Maximum Observed Plasma Drug Concentration (Cmax) | Day 3 | 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. |
| Secondary | Plasma PK: Minimum Observed Plasma Drug Concentration (Cmin) | Day 3 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 | Day 5 | 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. | percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC) | Day 17 TOC Visit | 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. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at Day 5 | Day 5 | 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. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at TOC | Day 17 TOC Visit | 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. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 32 | The safety population included all randomized patients who received any amount of study drug. | percentage of patients | NUMBER |
| SECONDARY | Plasma Pharmacokinetics (PK): Area Under the Curve From 0 to 24 Hours (AUC 0-24h) | Day 3 | 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. | mg*h/L (milligrams times hour per liter) | GEOMETRIC_MEAN |
| SECONDARY | Plasma PK: Maximum Observed Plasma Drug Concentration (Cmax) | Day 3 | 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. | mg/L | GEOMETRIC_MEAN |
| SECONDARY | Plasma PK: Minimum Observed Plasma Drug Concentration (Cmin) | Day 3 | 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. | mg/L | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 | Plazomicin | Composite Cure | 88 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 | Meropenem | Composite Cure | 91.4 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 | Plazomicin | Composite Failure | 10.5 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 | Meropenem | Composite Failure | 7.6 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 | Plazomicin | Indeterminate | 1.6 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 | Meropenem | Indeterminate | 1 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC) | Plazomicin | Composite Cure | 81.7 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC) | Meropenem | Composite Cure | 70.1 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC) | Plazomicin | Composite Failure | 15.2 | percentage of patients | |
| Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC) | Meropenem | Composite Failure | 25.9 | percentage of patients |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Plazomicin | 306 | |
| Overall Study | STARTED | Meropenem | 303 | |
| Overall Study | COMPLETED | Plazomicin | 299 | |
| Overall Study | COMPLETED | Meropenem | 294 | |
| Overall Study | NOT COMPLETED | Plazomicin | 7 | |
| Overall Study | NOT COMPLETED | Meropenem | 9 |
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 |
|---|---|---|---|---|---|---|
| serious | Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Plazomicin | 1 | 303 | |
| serious | Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Meropenem | 0 | 301 | |
| serious | Pyrexia | General disorders | Plazomicin | 0 | 303 | |
| serious | Pyrexia | General disorders | Meropenem | 1 | 301 | |
| serious | Pancreatitis | Gastrointestinal disorders | Plazomicin | 0 | 303 | |
| serious | Pancreatitis | Gastrointestinal disorders | Meropenem | 1 | 301 | |
| serious | Acute kidney injury | Renal and urinary disorders | Plazomicin | 2 | 303 | |
| serious | Acute kidney injury | Renal and urinary disorders | Meropenem | 0 | 301 | |
| serious | Calculus urinary | Renal and urinary disorders | Plazomicin | 1 | 303 | |
| serious | Calculus urinary | Renal and urinary disorders | Meropenem | 0 | 301 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Plazomicin | 1 | 303 |
| Total, all-cause mortality | Meropenem | 0 | 301 |
| Total, other adverse events | Plazomicin | 0 | 303 |
| Total, other adverse events | Meropenem | 0 | 301 |
| Total, serious adverse events | Plazomicin | 5 | 303 |
| Total, serious adverse events | Meropenem | 5 | 301 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30786187 | DERIVED |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Plazomicin vs Meropenem: deaths from any cause | Trial comparisons |
| Plazomicin vs Meropenem: serious adverse events | Trial comparisons |
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/NCT02486627
GET https://conductscience.org/api/trials/v1/NCT02486627/results?page=2