Trial · NCT02166476
Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP
NCT02166476, Phase 3, Completed, Melinta Therapeutics, Inc.; results first posted 2017-10-26
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ConductScience Library. Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP. Trials, record NCT02166476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02166476
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP
- NCT number
- NCT02166476
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 550 participants, actual
- Lead sponsor
- Melinta Therapeutics, Inc.
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis
- Interventions
- Meropenem-Vaborbactam, Piperacillin-Tazobactam, Levofloxacin, Saline
- First posted
- 2014-06-18
- Last updated
- 2018-06-11
- Results first posted
- 2017-10-26
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit | EOIVT (Days 5-14) | This was the primary outcome measure for the Food and Drug Administration (FDA). For this composite outcome measure, overall success was achieved with a clinical outcome of Cure or Improvement and microbiologic outcome of Eradication at the end of intravenous treatment (EOIVT). Cure was defined as the complete resolution or significant improvement of the baseline signs and symptoms. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms. Eradication was defined using the FDA's colony-forming units (CFU)/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to \<10\^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). |
| Primary | Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit | Test of cure (TOC) (Days 15-23) | This was the primary outcome measure for the European Medicines Agency (EMA). For this measure, a microbiologic outcome of Eradication was defined using the EMA's CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to \<10\^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). |
| Primary | Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit | TOC (Days 15-23) | This was the primary outcome measure for the EMA. For this measure, a microbiologic outcome of Eradication was defined using the EMA's CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to \<10\^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). The ME population included all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received \<80% or \>120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure. |
| Secondary | Proportion Of Participants In The m-MITT Population With Overall Success | EOIVT (Days 5-14) and TOC (Days 15-23) | This secondary outcome measure focused on the overall success in the ME population at the EOIVT and TOC visits. Overall success at TOC was defined as a clinical outcome of Cured and a microbiologic outcome of Eradication. Overall success at EOIVT was defined as a clinical outcome of Cured or Improvement and a microbiologic outcome of Eradication. Cured was defined as the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms of cUTI or AP, but continued IV therapy was warranted. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to \<10\^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). |
| Secondary | Proportion Of Participants In The ME Population With Overall Success | EOIVT (Days 5-14) and TOC (Days 15-23) | This secondary outcome measure focused on the overall success in the ME population at the EOIVT and TOC visits. Overall success was defined as a clinical outcome of Cured or Improvement and a microbiologic outcome of Eradication. Cured was defined as the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms of cUTI or AP, but continued IV therapy was warranted. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to \<10\^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). |
| Secondary | Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | This secondary outcome measure focused on a microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, end of treatment (EOT), TOC, and late follow up (LFU). Eradication was defined as a reduction in baseline bacterial pathogen(s) to \<10\^4 CFU/mL of urine culture (FDA) or \<10\^3 CFU/mL (EMA), and a negative blood culture for an organism that was identified as a uropathogen (if repeated after positive at baseline blood culture). |
| Secondary | Proportion Of Participants In The ME Population Who Achieved A Microbiologic Outcome Of Eradication | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | This secondary outcome measure focused on a microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined as a reduction in baseline bacterial pathogen(s) to \<10\^4 CFU/mL of urine culture (FDA) or \<10\^3 CFU/mL (EMA), and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). |
| Secondary | Proportion Of Participants With A Clinical Outcome Of Cure In The m-MITT Population | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | This secondary outcome measure focused on a clinical outcome of Cure in the m-MITT Population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at Day 3, EOIVT, and EOT visits. |
| Secondary | Proportion Of Participants With A Clinical Outcome Of Cure In The Clinical Evaluable (CE) Population | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | This secondary outcome measure focused on a clinical outcome of Cure in the CE population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at the Day 3, EOIVT, and EOT visits. |
| Secondary | Proportion Of Participants With A Clinical Outcome Of Cure In The ME Population | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | This secondary outcome measure focused on a clinical outcome of Cure in the ME population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at the Day 3, EOIVT, and EOT visits. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit | EOIVT (Days 5-14) | The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10\^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit | Test of cure (TOC) (Days 15-23) | The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10\^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit | TOC (Days 15-23) | ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received \<80% or \>120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion Of Participants In The m-MITT Population With Overall Success | EOIVT (Days 5-14) and TOC (Days 15-23) | The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10\^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion Of Participants In The ME Population With Overall Success | EOIVT (Days 5-14) and TOC (Days 15-23) | ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received \<80% or \>120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10\^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion Of Participants In The ME Population Who Achieved A Microbiologic Outcome Of Eradication | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received \<80% or \>120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion Of Participants With A Clinical Outcome Of Cure In The m-MITT Population | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10\^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion Of Participants With A Clinical Outcome Of Cure In The Clinical Evaluable (CE) Population | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | CE population: all participants who received ≥1 dose of drug (MITT), had no key inclusion/exclusion criteria violations, had a clinical outcome (Cure, Improvement, Failure) at EOIVT, received 80-120% of expected IV doses, missed ≤1 IV dose in the first 48 hours, missed ≤2 consecutive IV doses overall, received ≥6 doses (Failure) or ≥9 doses (Cure). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion Of Participants With A Clinical Outcome Of Cure In The ME Population | Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30) | ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received \<80% or \>120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group258
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit | Meropenem-Vaborbactam | 189 | Participants | ||
| Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit | Piperacillin-Tazobactam | 171 | Participants | ||
| Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit | Meropenem-Vaborbactam | 128 | Participants | ||
| Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit | Piperacillin-Tazobactam | 105 | Participants | ||
| Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit | Meropenem-Vaborbactam | 118 | Participants | ||
| Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit | Piperacillin-Tazobactam | 102 | Participants | ||
| Proportion Of Participants In The m-MITT Population With Overall Success | Meropenem-Vaborbactam | EOIVT | 189 | Participants | |
| Proportion Of Participants In The m-MITT Population With Overall Success | Piperacillin-Tazobactam | EOIVT | 171 | Participants | |
| Proportion Of Participants In The m-MITT Population With Overall Success | Meropenem-Vaborbactam | TOC | 143 | Participants | |
| Proportion Of Participants In The m-MITT Population With Overall Success | Piperacillin-Tazobactam | TOC | 128 | Participants |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Meropenem-Vaborbactam | 272 | |
| Overall Study | STARTED | Piperacillin-Tazobactam | 273 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Meropenem-Vaborbactam | 272 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Piperacillin-Tazobactam | 273 | |
| Overall Study | COMPLETED | Meropenem-Vaborbactam | 258 | |
| Overall Study | COMPLETED | Piperacillin-Tazobactam | 250 | |
| Overall Study | NOT COMPLETED | Meropenem-Vaborbactam | 14 | |
| Overall Study | NOT COMPLETED | Piperacillin-Tazobactam | 23 |
Source ClinicalTrials.gov
Adverse events50
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 | Headache | Nervous system disorders | Meropenem-Vaborbactam | 24 | 272 | |
| other | Headache | Nervous system disorders | Piperacillin-Tazobactam | 12 | 273 | |
| other | Diarrhoea | Gastrointestinal disorders | Meropenem-Vaborbactam | 9 | 272 | |
| other | Diarrhoea | Gastrointestinal disorders | Piperacillin-Tazobactam | 12 | 273 | |
| other | Infusion Site Phlebitis | General disorders | Meropenem-Vaborbactam | 6 | 272 | |
| other | Infusion Site Phlebitis | General disorders | Piperacillin-Tazobactam | 2 | 273 | |
| other | Vaginal Infection | Infections and infestations | Meropenem-Vaborbactam | 1 | 272 | |
| other | Vaginal Infection | Infections and infestations | Piperacillin-Tazobactam | 6 | 273 | |
| serious | Cardiac failure congestive | Cardiac disorders | Meropenem-Vaborbactam | 1 | 272 | |
| serious | Cardiac failure congestive | Cardiac disorders | Piperacillin-Tazobactam | 0 | 273 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Meropenem-Vaborbactam | 2 | 272 |
| Total, all-cause mortality | Piperacillin-Tazobactam | 2 | 273 |
| Total, other adverse events | Meropenem-Vaborbactam | 36 | 272 |
| Total, other adverse events | Piperacillin-Tazobactam | 31 | 273 |
| Total, serious adverse events | Meropenem-Vaborbactam | 11 | 272 |
| Total, serious adverse events | Piperacillin-Tazobactam | 12 | 273 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29486041 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Meropenem-Vaborbactam vs Piperacillin-Tazobactam: Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit | Trial comparisons |
Meropenem-Vaborbactam vs Piperacillin-Tazobactam: Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit | Trial comparisons |
| Meropenem-Vaborbactam vs Piperacillin-Tazobactam: Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit | Trial comparisons |
| Meropenem-Vaborbactam vs Piperacillin-Tazobactam: deaths from any cause | Trial comparisons |
| Meropenem-Vaborbactam vs Piperacillin-Tazobactam: 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.
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