Trial · NCT02168946
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
NCT02168946, Phase 3, Completed, Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.); results first posted 2018-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults. Trials, record NCT02168946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02168946
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
- NCT number
- NCT02168946
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 77 participants, actual
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia, Abdominal Infection
- Interventions
- Vabomere, Best Available Therapy
- First posted
- 2014-06-20
- Last updated
- 2019-03-04
- Results first posted
- 2018-12-11
- Limitations and caveats
- Enrollment Challenges required the Sponsor to terminate the study early which led to a smaller number of patients being enrolled.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects] | at Test of Cure (TOC) visit (Day 12-23) | Overall success is defined as clinical cure \& microbiological eradication. Eradication defined by FDA as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 colony forming unit (CFU)/mL urine. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Primary | All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects) | Day 28 | The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia) |
| Primary | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only] | at TOC visit (Day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted. |
| Secondary | The All-cause Mortality Rate in the mCRE-MITT Population (All Indications) | at Day 28 | All Cause Mortality at Day 28 in the mCRE-MITT population (all indications) |
| Secondary | The All-cause Mortality Rate in the m-MITT Population (All Indications) | at Day 28 | The All Cause Mortality rate at Day 28 in the m-MITT population (all indications) |
| Secondary | The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP) | at Day 28 | All Cause Mortality at Day 28 in the mCRE-MITT population (cUTI/AP subjects only) |
| Secondary | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications) | at End of Therapy (EOT) visit (7-14 days) and TOC visit (12-23 days) | Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only) | at EOT visit (7-14) and TOC visit (day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia) | at EOT visit (7-14) and TOC visit (day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications) | at EOT visit (7-14) and TOC visit (day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted. |
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 | Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects] | at Test of Cure (TOC) visit (Day 12-23) | The mCRE-MITT population includes all patients who had confirmed Carbapenem-Resistant Enterobacteriaceae at Baseline. (cUTI/AP patients only) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects) | Day 28 | mCRE-MITT Population (HABP/VABP and Bacteremia subjects only) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only] | at TOC visit (Day 12-23) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The All-cause Mortality Rate in the mCRE-MITT Population (All Indications) | at Day 28 | mCRE-MITT population (all indications) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The All-cause Mortality Rate in the m-MITT Population (All Indications) | at Day 28 | The m-MITT population includes all patients who receive at least one dose of study drug and have a baseline gram negative bacterial pathogen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP) | at Day 28 | mCRE-MITT (cUTI/AP subjects only) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications) | at End of Therapy (EOT) visit (7-14 days) and TOC visit (12-23 days) | mCRE-MITT population (all indications) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only) | at EOT visit (7-14) and TOC visit (day 12-23) | mCRE-MITT population (cUTI/AP subjects only) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia) | at EOT visit (7-14) and TOC visit (day 12-23) | mCRE-MITT (HABP/VABP or Bacteremia Subjects only) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications) | at EOT visit (7-14) and TOC visit (day 12-23) | m-MITT Population (all indications) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects] | Vabomere | 4 | Participants | ||
Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects] | Best Available Therapy | 2 | Participants | ||
| All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects) | Vabomere | 4 | Participants | ||
| All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects) | Best Available Therapy | 4 | Participants | ||
| Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only] | Vabomere | 2 | Participants | ||
| Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only] | Best Available Therapy | 0 | Participants | ||
| The All-cause Mortality Rate in the mCRE-MITT Population (All Indications) | Vabomere | 5 | Participants | ||
| The All-cause Mortality Rate in the mCRE-MITT Population (All Indications) | Best Available Therapy | 5 | Participants | ||
| The All-cause Mortality Rate in the m-MITT Population (All Indications) | Vabomere | 5 | Participants | ||
| The All-cause Mortality Rate in the m-MITT Population (All Indications) | Best Available Therapy | 5 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vabomere | 50 | |
| Overall Study | STARTED | Best Available Therapy | 25 | |
| Overall Study | COMPLETED | Vabomere | 38 | |
| Overall Study | COMPLETED | Best Available Therapy | 20 | |
| Overall Study | NOT COMPLETED | Vabomere | 12 | |
| Overall Study | NOT COMPLETED | Best Available Therapy | 5 |
Source ClinicalTrials.gov
Adverse events222
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 | Diarrhea | Gastrointestinal disorders | Vabomere | 6 | 50 | |
| other | Diarrhea | Gastrointestinal disorders | Best Available Therapy | 4 | 25 | |
| other | Nausea | Gastrointestinal disorders | Vabomere | 2 | 50 | |
| other | Nausea | Gastrointestinal disorders | Best Available Therapy | 2 | 25 | |
| other | Vomiting | Gastrointestinal disorders | Vabomere | 4 | 50 | |
| other | Vomiting | Gastrointestinal disorders | Best Available Therapy | 0 | 25 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Vabomere | 1 | 50 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Best Available Therapy | 2 | 25 | |
| other | Constipation | Gastrointestinal disorders | Vabomere | 2 | 50 | |
| other | Constipation | Gastrointestinal disorders | Best Available Therapy | 1 | 25 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vabomere | 10 | 50 |
| Total, all-cause mortality | Best Available Therapy | 6 | 25 |
| Total, other adverse events | Vabomere | 28 | 50 |
| Total, other adverse events | Best Available Therapy | 20 | 25 |
| Total, serious adverse events | Vabomere | 17 | 50 |
| Total, serious adverse events | Best Available Therapy | 11 | 25 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vabomere vs Best Available Therapy: Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only] | Trial comparisons |
Vabomere vs Best Available Therapy: Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects] | Trial comparisons |
Vabomere vs Best Available Therapy: All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects) | Trial comparisons |
| Vabomere vs Best Available Therapy: The All-cause Mortality Rate in the m-MITT Population (All Indications) | Trial comparisons |
| Vabomere vs Best Available Therapy: The All-cause Mortality Rate in the mCRE-MITT Population (All Indications) | Trial comparisons |
| Vabomere vs Best Available Therapy: The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP) | Trial comparisons |
| Vabomere vs Best Available Therapy: deaths from any cause | Trial comparisons |
| Vabomere vs Best Available Therapy: 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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