Phase 3
N=75
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
Urinary Tract Infection Complicated · Acute Pyelonephritis · Hospital Acquired Bacterial Pneumonia · Ventilator-associated Bacterial Pneumonia · Bacteremia
Bottom Line
View on ClinicalTrials.gov: NCT02168946 ↗Enrolled (actual)
75
Serious AEs
37.3%
Results posted
Dec 2018
Primary outcome: 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] — 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vabomere (Drug); Best Available Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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] |
4; 2 | — |
| PRIMARY All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects) |
4; 4 | — |
| PRIMARY Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only] |
2; 0 | — |
| SECONDARY The All-cause Mortality Rate in the mCRE-MITT Population (All Indications) |
5; 5 | — |
| SECONDARY The All-cause Mortality Rate in the m-MITT Population (All Indications) |
5; 5 | — |
| SECONDARY The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP) |
1; 0 | — |
| SECONDARY Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications) |
21; 5; 19; 4 | — |
| SECONDARY Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only) |
9; 2; 5; 2 | — |
| SECONDARY Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia) |
10; 3; 12; 2 | — |
| SECONDARY Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications) |
24; 7; 21; 6 | — |
| SECONDARY Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP) |
10; 4; 6; 4 | — |
| SECONDARY Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia) |
12; 3; 13; 2 | — |
| SECONDARY Proportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications) |
21; 6; 17; 5 | — |
| SECONDARY Proportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications) |
23; 8; 17; 7 | — |
| SECONDARY Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP) |
10; 4; 4; 4 | — |
| SECONDARY Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only) |
8; 3; 8; 2 | — |
Summary
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
Eligibility Criteria
- Inclusion Criteria:
- Willingness to comply with all study activities and procedures and to provide signed, written informed consent prior to any study procedures. If a subject is unable to provide informed consent due to their medical condition, the subject's legal representative will be provided with study information in order for consent to be obtained.
- Hospitalized male or female, ≥18 years of age.
- Weight ≤185 kg.
- Have a confirmed diagnosis of a serious infection, specifically cUTI or AP, cIAI, HABP, VABP, and/or bacteremia, requiring administration of IV antibacterial therapy.
- Have a known or suspected Carbapenem-Resistant Enterobacteriaceae (CRE) infection.
- Expectation, in the opinion of the Investigator, that the subject's infection will require treatment with IV antibiotics for a minimum of 7 days.
- Expectation that subjects with an estimated creatinine clearance 30.
- Known or suspected endocarditis, meningitis, intra-abdominal infection, or osteomyelitis.
- Irremovable or implantable device or line thought to be the potential source of infection.
- Evidence of significant hepatic, hematological, or immunologic disease or dysfunction.
- Women who are pregnant or breastfeeding.
- Require the use of inhaled antibiotics.
- Participation in any study involving administration of an investigational agent or device within 30 days prior to randomization into this study or previous participation in the current study.
- Previous participation in a study of vaborbactam.
- Any condition that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data.
Data sourced from ClinicalTrials.gov (NCT02168946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.