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CompletedNCT02168946Updated Mar 4, 2019Results posted

Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults

A Phase 3 interventional study of Vabomere and Best Available Therapy in Urinary Tract Infection Complicated, Acute Pyelonephritis and Hospital Acquired Bacterial Pneumonia, sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.). Completed at 50 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-04.

Sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) (part of CorMedix Therapeutics) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 79 studies in Bacteremia with a site in United States — 6 open to participants now, 8 under way, none of them phase 3. Bacteremia · United States.

Enrollment
24th of 45
77 · median 85
Started
2014
with 3 others
Phase 3
7 of 79
none open now
Registered
41st of 79
by date

Among the 79 studies in Bacteremia with a site in United States, this one is the 24th largest by enrollment of the 45 interventional ones, is one of 4 that started in 2014, is one of 7 in phase 3, and was the 41st registered.

By phase

79 studies; the count open now beside each. This study's row is marked.

Observational32 · 2 open
No phase11 · 1 open
Phase 211 · 1 open
Phase 411 · 2 open
Phase 3this study7 · 0 open
Phase 14 · 0 open
Phase 1/22 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2000; this study’s year is marked. 4 started in 2014.

Size and results

Median enrollment 85 across the 45 interventional studies, 470 across the 32 observational. Of the 64 that completed or were terminated, 24 (38%) have results posted.

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02

Study 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

Read the detailed description

In the current era of increased resistance to extended spectrum cephalosporins and penicillin/beta-lactamase inhibitor combinations, carbapenem antimicrobial agents are frequently the antibiotics of "last defense" for the most resistant pathogens in serious infections. However, the recent dissemination of serine carbapenemases (e.g. KPC) in Enterobacteriaceae within many hospitals worldwide now poses a considerable threat to carbapenems and other members of the beta-lactam class of antimicrobial agents.

Infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) are associated with high mortality rates and have limited treatment options. The loss of the carbapenem class of antimicrobial agents for treatment of Enterobacteriaceae (the most frequently occurring pathogens in the hospital setting), Acinetobacter baumannii, and Pseudomonas aeruginosa represents a critical setback in modern patient care.

As a result of the current lack of an optimal treatment for patients who have infections due to a CRE, physicians manage these patients with the limited anti-infective options available, including aminoglycosides, polymyxin B, colistin, tigecycline, or various combinations of these. There are limited efficacy data available for many of these therapies when used to treat serious CRE infections, particularly in combination, but with limited or no alternative therapies currently available, such treatments have become the Best Available Therapy despite the toxicities associated with many of them.

Vaborbactam is a novel beta-lactamase inhibitor that has inhibitory activity against many serine beta-lactamases and was optimized for inhibition of the KPC beta-lactamase and the potentiation of carbapenems against Enterobacteriaceae. Vaborbactam is being developed for use with meropenem (a broad spectrum injectable carbapenem antibiotic) to address the challenges of treatment of serious infections caused by pathogens increasingly resistant to available treatments.

Vabomere, (meropenem-vaborbactam) administered as a fixed combination by intravenous (IV) infusion, is being developed to treat serious gram-negative infections, such as complicated urinary tract infections (cUTI), acute pyelonephritis (AP), hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and bacteremia, including those infections caused by bacteria resistant to currently available carbapenems.

03

Conditions studied

  • Urinary Tract Infection Complicated
  • Acute Pyelonephritis
  • Hospital Acquired Bacterial Pneumonia
  • Ventilator-associated Bacterial Pneumonia
  • Bacteremia
  • Abdominal Infection
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willingness to comply with all study activities and procedures and to provide signed, written 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.

    1. Hospitalized male or female, ≥18 years of age.
    2. Weight ≤185 kg.
    3. Have a confirmed diagnosis of a serious infection, specifically cUTI or AP, cIAI, HABP, VABP, and/or bacteremia, requiring administration of IV antibacterial therapy.
    4. Have a known or suspected Carbapenem-Resistant Enterobacteriaceae (CRE) infection.
    5. Expectation, in the opinion of the Investigator, that the subject's infection will require treatment with IV antibiotics for a minimum of 7 days.
    6. Expectation that subjects with an estimated \<10 ml/min (Cockcroft-Gault) will receive hemodialysis at least 2 times per week.

    7. For cUTI \& AP subjects only: expectation, in the judgment of the Investigator, that any indwelling urinary catheter or instrumentation (including nephrostomy tubes and/or indwelling stents) will be removed or replaced (if removal is not clinically acceptable) before or as soon as possible, but not longer than 12 hours, after randomization.

      For cIAI subjects only: • Expectation, in the judgment of the investigator, that operative drainage/debridement/removal (including open laparotomy, percutaneous drainage, or laparoscopic surgery) of any intra-abdominal collection or other potential source of intra abdominal infection will be performed;

      • Expectation that cultures from the aforementioned procedure (including open laparotomy, percutaneous drainage, or laparoscopic surgery) will be sent for microbiological evaluation, including gram stain, culture and susceptibility testing, and Vabomere susceptibility testing.
    8. Female subjects of , including those who are less than 2 years post menopausal, must agree to, and comply with, using 2 highly effective methods of (i.e., condom plus spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in this study. In addition, all women of childbearing potential must agree to continue to use 2 forms of birth control throughout the study and for at least 30 days after administration of the last dose of study drug.

Exclusion criteria

  1. History of any significant or severe allergic reaction to any beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams).

    1. Known or suspected likely infection with New Delhi metallo- (NDM), Verona integron-encoded metallo- (VIM), or IMP-metallo-beta-lactamases or oxacillinase- (OXA)-beta-lactamases (i.e., Class B or Class D beta-lactamases).

    2. For subjects to be enrolled with the primary indication of cUTI or AP, any of the following urologic conditions:

      1. Likely to receive ongoing antibacterial drug prophylaxis after treatment of cUTI (e.g., subjects with vesico-ureteral reflux);
      2. Suspected or confirmed prostatitis;
      3. Requirement for bladder irrigation with antibiotics or for antibiotics to be administered directly via urinary catheter;
      4. Previous or planned cystectomy or ileal loop surgery;
      5. Uncomplicated urinary tract infection (for example, female subjects with urinary frequency, urgency or pain or discomfort without systemic symptoms or signs of infection);
      6. Complete, permanent obstruction of the urinary tract;
      7. Suspected or confirmed perinephric or renal corticomedullary abscess;
      8. Polycystic kidney disease; or
      9. Any recent history of trauma to the pelvis or urinary tract.

    3. For subjects to be enrolled with the primary indication of cIAI, any of the following conditions:

      1. Incomplete drainage of suspected or known intra-abdominal source;
      2. Likely to receive ongoing antibacterial drug prophylaxis or chronic suppressive therapy after intravenous treatment of cIAI;
      3. Source of infection thought to be related to or involving a non-removable prosthesis (e.g. intra-abdominal mesh) or implantable device, line (e.g. peritoneal catheter) or stent (e.g. biliary stent);
      4. Uncomplicated intra-abdominal infection, such as simple appendicitis, simple cholecystitis or gangrenous cholecystitis without rupture;
      5. Patients with infected necrotizing pancreatitis or pancreatic abscess;
      6. Patients whose surgery will include staged abdominal repair or "open abdomen" technique, or marsupialization (i.e. patients who undergo a surgical procedure where fascial closure is performed are eligible. The skin incision may be left open for purposes of wound management as long as fascial closure is accomplished);
      7. Patients in whom the intra-abdominal process is deemed not likely to be infectious in origin (e.g. bowel obstruction, ischemic bowel without perforation, traumatic bowel perforation within past 12 hours, perforated gastroduodenal ulcer within 24 hours); or
      8. Non-intra-abdominal infection (e.g. infection or abscess of the abdominal wall without extension into the intra-abdominal cavity).

    4. For subjects to be enrolled with the primary indication of HABP or VABP, any of the following conditions:

      1. Diagnosis of ventilator-associated tracheobronchitis
      2. Inability to obtain proper respiratory specimens for culture.

    5. For subjects to be enrolled with the indication of bacteremia unrelated to cUTI or AP, cIAI, HABP, and VABP, any of the following:

      1. Unverified CRE infection
      2. Source of infection thought to be related to or involving a non-removable or implantable device or line.
    6. Evidence of immediately life-threatening disease where in the opinion of the Investigator, the subject is unlikely to survive more than 72 hours from randomization.
    7. Acute Physiology and Chronic Health Evaluation (APACHE) II score >30.
    8. Known or suspected endocarditis, meningitis, intra-abdominal infection, or osteomyelitis.
    9. Irremovable or implantable device or line thought to be the potential source of infection.
    10. Evidence of significant hepatic, hematological, or immunologic disease or dysfunction.
    11. Women who are pregnant or breastfeeding.
    12. Require the use of inhaled antibiotics.
    13. Participation in any study involving administration of an agent or device within 30 days prior to randomization into this study or previous participation in the current study.
    14. Previous participation in a study of vaborbactam.
    15. Any condition that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Vabomere

    Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days

    Drug: Vabomere

  • Active comparator
    Best Available Therapy

    Subjects will receive Best Available Therapy (IV antibiotics)

    Drug: Best Available Therapy

Interventions

  • DrugVabomere

    Vabomere for IV injection, administered as a 2 g/2 g dose

    Also known as: Combination meropenem and vaborbactam, beta-lactamase inhibitor and carbapenem antibiotic

  • DrugBest Available Therapy

    Antibiotic(s) chosen by Investigator

    Also known as: IV Antibiotics

06

What researchers measure

Primary outcomes

  1. 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]

    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.

    Time frame: at Test of Cure (TOC) visit (Day 12-23)

  2. All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects)

    The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia)

    Time frame: Day 28

  3. Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only]

    Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.

    Time frame: at TOC visit (Day 12-23)

Secondary outcomes

  1. The All-cause Mortality Rate in the mCRE-MITT Population (All Indications)

    All Cause Mortality at Day 28 in the mCRE-MITT population (all indications)

    Time frame: at Day 28

  2. The All-cause Mortality Rate in the m-MITT Population (All Indications)

    The All Cause Mortality rate at Day 28 in the m-MITT population (all indications)

    Time frame: at Day 28

  3. The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP)

    All Cause Mortality at Day 28 in the mCRE-MITT population (cUTI/AP subjects only)

    Time frame: at Day 28

  4. Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications)

    Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

    Time frame: at End of Therapy (EOT) visit (7-14 days) and TOC visit (12-23 days)

  5. Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only)

    Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

  6. Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)

    Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

  7. Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications)

    Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

  8. Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP)

    Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

  9. Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)

    Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

  10. Proportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications)

    Includes subjects with microbiologic eradication or presumed eradication as defined: microbiologic eradication of the baseline pathogen or absence of culture result (microbiologic outcome of indeterminate or not assesses) where subject is deemed as clinical cure at that visit. For cUTI/AP subjects, demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA).

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

  11. Proportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications)

    Microbiological eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA).

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

  12. Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP)

    Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA). Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

  13. Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only)

    Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

    Time frame: at EOT visit (7-14) and TOC visit (day 12-23)

07

Results

Posted Dec 11, 2018
Limitations and caveats
Enrollment Challenges required the Sponsor to terminate the study early which led to a smaller number of patients being enrolled.

Participant flow

The first patient enrolled November 2014 and last patient in June 2017. The patients were enrolled at 27 study sites in 8 countries. 77 patients (28 with bacteremia, 34 with cUTI, 8 with HABP/VABP and 7 with cIAI) were enrolled and 47 had confirmed Carbapenem-Resistant Enterobacteriaceae and therefore were included in the mCRE population.

Participant flow — Overall Study
MilestoneVabomereBest Available Therapy
Started5025
Completed3820
Not completed125
Withdrew: Adverse event85
Withdrew: Lost to follow-up30
Withdrew: Subject unable to come back for visits10

Outcome measures

PrimaryProportion 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]

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.

Time frame:
at Test of Cure (TOC) visit (Day 12-23)
Reported as:
Count of participants · 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]
ParticipantsVabomereBest 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]42
PrimaryAll-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects)

The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia)

Time frame:
Day 28
Reported as:
Count of participants · Participants
All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects)
ParticipantsVabomereBest Available Therapy
All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects)44
PrimaryProportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only]

Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.

Time frame:
at TOC visit (Day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only]
ParticipantsVabomereBest Available Therapy
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only]20
SecondaryThe All-cause Mortality Rate in the mCRE-MITT Population (All Indications)

All Cause Mortality at Day 28 in the mCRE-MITT population (all indications)

Time frame:
at Day 28
Reported as:
Count of participants · Participants
The All-cause Mortality Rate in the mCRE-MITT Population (All Indications)
ParticipantsVabomereBest Available Therapy
The All-cause Mortality Rate in the mCRE-MITT Population (All Indications)55
SecondaryThe All-cause Mortality Rate in the m-MITT Population (All Indications)

The All Cause Mortality rate at Day 28 in the m-MITT population (all indications)

Time frame:
at Day 28
Reported as:
Count of participants · Participants
The All-cause Mortality Rate in the m-MITT Population (All Indications)
ParticipantsVabomereBest Available Therapy
The All-cause Mortality Rate in the m-MITT Population (All Indications)55
SecondaryThe All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP)

All Cause Mortality at Day 28 in the mCRE-MITT population (cUTI/AP subjects only)

Time frame:
at Day 28
Reported as:
Count of participants · Participants
The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP)
ParticipantsVabomereBest Available Therapy
The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP)10
SecondaryProportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications)

Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

Time frame:
at End of Therapy (EOT) visit (7-14 days) and TOC visit (12-23 days)
Reported as:
Count of participants · Participants
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications)
ParticipantsVabomereBest Available Therapy
EOT215
TOC194
SecondaryProportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only)

Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only)
ParticipantsVabomereBest Available Therapy
EOT92
TOC52
SecondaryProportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)

Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)
ParticipantsVabomereBest Available Therapy
EOT103
TOC122
SecondaryProportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications)

Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications)
ParticipantsVabomereBest Available Therapy
EOT247
TOC216
SecondaryProportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP)

Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP)
ParticipantsVabomereBest Available Therapy
EOT104
TOC64
SecondaryProportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)

Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)
ParticipantsVabomereBest Available Therapy
EOT123
TOC132
SecondaryProportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications)

Includes subjects with microbiologic eradication or presumed eradication as defined: microbiologic eradication of the baseline pathogen or absence of culture result (microbiologic outcome of indeterminate or not assesses) where subject is deemed as clinical cure at that visit. For cUTI/AP subjects, demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA).

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications)
ParticipantsVabomereBest Available Therapy
EOT216
TOC175
SecondaryProportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications)

Microbiological eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA).

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications)
ParticipantsVabomereBest Available Therapy
EOT238
TOC177
SecondaryProportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP)

Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA). Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP)
ParticipantsVabomereBest Available Therapy
EOT104
TOC44
SecondaryProportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only)

Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.

Time frame:
at EOT visit (7-14) and TOC visit (day 12-23)
Reported as:
Count of participants · Participants
Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only)
ParticipantsVabomereBest Available Therapy
EOT83
TOC82

Adverse events

Collected over Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days). Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vabomere10/50 (20%)17/50 (34%)28/50 (56%)
Best Available Therapy6/25 (24%)11/25 (44%)20/25 (80%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventVabomereBest Available Therapy
SepsisInfections and infestations2/504/25
Septic ShockInfections and infestations1/504/25
AnemiaBlood and lymphatic system disorders0/501/25
Cardiac ArrestCardiac disorders2/500/25
Cardiac Failure CongestiveCardiac disorders0/501/25
General Physical Health DeteriorationGeneral disorders2/500/25
Clostridium difficile colitisInfections and infestations0/501/25
PeritonitisInfections and infestations0/501/25
Cerebral HemorrhageNervous system disorders0/501/25
ConvulsionNervous system disorders0/501/25
Most frequent other events
Showing 10 of 86
Most frequent other events
EventVabomereBest Available Therapy
DiarrheaGastrointestinal disorders6/504/25
HypotensionVascular disorders4/503/25
Renal Failure AcuteRenal and urinary disorders1/503/25
AnemiaBlood and lymphatic system disorders5/502/25
HypokalemiaMetabolism and nutrition disorders5/502/25
NauseaGastrointestinal disorders2/502/25
VomitingGastrointestinal disorders4/500/25
Abdominal Pain UpperGastrointestinal disorders1/502/25
ThrombocytopeniaBlood and lymphatic system disorders2/502/25
HypoglycemiaMetabolism and nutrition disorders4/500/25

Baseline characteristics

All randomized subjects who received at least one dose of study drug (MITT and Safety Population)

Age, Categorical
Age, Categorical(Participants)VabomereBest Available TherapyTotal
<=18 years000
Between 18 and 65 years261440
>=65 years241135
Age, Continuous
Age, Continuous(years)VabomereBest Available TherapyTotal
Mean63.6 ± 15.3063.2 ± 13.1063.5 ± 14.51
Sex: Female, Male
Sex: Female, Male(Participants)VabomereBest Available TherapyTotal
Female25732
Male251843
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VabomereBest Available TherapyTotal
Hispanic or Latino9514
Not Hispanic or Latino412061
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VabomereBest Available TherapyTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American325
White432265
More than one race000
Unknown or Not Reported303
Body Mass Index
Body Mass Index(kg/m^2)VabomereBest Available TherapyTotal
Mean27.90 ± 8.34027.14 ± 7.52227.64 ± 8.029
Systemic Inflammatory Response Syndrome (SIRS) present
Systemic Inflammatory Response Syndrome (SIRS) present(Participants)VabomereBest Available TherapyTotal
Count of participants221032
Creatinine Clearance <50 mL/min
Creatinine Clearance <50 mL/min(Participants)VabomereBest Available TherapyTotal
Count of participants12921

1 further baseline measures are reported on the registry.

08

Study locations

50 sites
  • Hartford, Connecticut 06102, United States
  • Tampa, Florida 33606, United States
  • Augusta, Georgia 30912, United States
  • Chicago, Illinois 60611, United States
  • Chicago, Illinois 60612, United States
  • Evanston, Illinois 60201, United States
  • Indianapolis, Indiana 46202, United States
  • Detroit, Michigan 48201, United States
  • Royal Oak, Michigan 48073, United States
  • New Brunswick, New Jersey 08901, United States
  • Bronx, New York 10467, United States
  • Buffalo, New York 14215, United States
  • Flushing, New York 11355, United States
  • New York, New York 10032, United States
  • Charlotte, North Carolina 28207, United States
  • Durham, North Carolina 27710, United States
  • Cleveland, Ohio 44106, United States
  • Philadelphia, Pennsylvania 19104, United States
  • Pittsburgh, Pennsylvania 15213, United States
  • Charlottesville, Virginia 22908, United States
  • Ciudad Autónoma de Buenos Aires, C1405CNF, Argentina
  • Córdoba, 5016, Argentina
  • La Plata, B1900AXI, Argentina
  • Mendoza, 5500, Argentina
  • Sao Jose do Rio Preto, São Paulo 05652-900, Brazil
  • Belo Horizonte, 30150-221, Brazil
  • Curitiba, 81050-000, Brazil
  • Porto Alegre, 90035-903, Brazil
  • Sao Paulo, SP, Brazil
  • São Paulo, 05652-900, Brazil
  • São Paulo, 14048-900, Brazil
  • Barranquilla, Colombia
  • Bogota, 0, Colombia
  • Medellin, 4, Colombia
  • Athens, 106 76, Greece
  • Athens, 11527, Greece
  • Athens, 12462, Greece
  • Thessaloniki, 54636, Greece
  • Haifa, 31096, Israel
  • Petah Tikva, 49100, Israel
  • Ramat Gan, 52621, Israel
  • Tel Aviv, 64239, Israel
  • Bologna, 40138, Italy
  • Firenze, 50134, Italy
  • Genova, 16132, Italy
  • Pisa, 56124, Italy
  • Rome, 00161, Italy
  • Udine, 33100, Italy
  • Manchester, M23 9LT, United Kingdom
  • Manchester, MI39WL, United Kingdom
09

References and documents

Publications

  • Bhowmick T. Clinical Outcomes of Patient Subgroups in the TANGO II Study. Infect Dis Ther. 2021 Mar;10(1):35-46. doi: 10.1007/s40121-021-00405-x. Epub 2021 Feb 9. PubMed 33565042 ↗
  • Wunderink RG, Giamarellos-Bourboulis EJ, Rahav G, Mathers AJ, Bassetti M, Vazquez J, Cornely OA, Solomkin J, Bhowmick T, Bishara J, Daikos GL, Felton T, Furst MJL, Kwak EJ, Menichetti F, Oren I, Alexander EL, Griffith D, Lomovskaya O, Loutit J, Zhang S, Dudley MN, Kaye KS. Effect and Safety of Meropenem-Vaborbactam versus Best-Available Therapy in Patients with Carbapenem-Resistant Enterobacteriaceae Infections: The TANGO II Randomized Clinical Trial. Infect Dis Ther. 2018 Dec;7(4):439-455. doi: 10.1007/s40121-018-0214-1. Epub 2018 Oct 1. PubMed 30270406 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of Jul 2017 and a completion of Jul 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2018, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2014
First posted
Jun 20, 2014
Start
Jul 2014
Primary completionActual
Jul 21, 2017
CompletionActual
Jul 21, 2017
Results first posted
Dec 11, 2018
Last update
Mar 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02168946
Lead sponsor
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Collaborators
Department of Health and Human Services
Responsible party
Sponsor
First posted
Jun 20, 2014
Start date
Jul 2014
Primary completion
Jul 21, 2017
Completion
Jul 21, 2017
Results posted
Dec 11, 2018
Last update
Mar 4, 2019

Study contacts

Karen Fusaro
study director · Sponsor GmbH
Keith Kaye
principal investigator · Wayne State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Meropenem and vaborbactam

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