Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious… (NCT02168946) | Clinical Trial Compass
CompletedPhase 3
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
United States77 participantsStarted 2014-07
Plain-language summary
Vabomereâ„¢, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
Who can participate
Age range18 Years
SexALL
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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 \<10 ml/min (Cockcroft-Gault) will receive hemodialysis at least 2 times per week.
✓. 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.
Exclusion criteria
✕. History of any significant hypersensitivity or severe allergic reaction to any beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams).
What they're measuring
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]
Timeframe: 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)
Timeframe: Day 28
3
Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only]
Timeframe: at TOC visit (Day 12-23)
Trial details
NCT IDNCT02168946
SponsorRempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
✕. 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).
✕. For subjects to be enrolled with the primary indication of cUTI or AP, any of the following urologic conditions:
✕. Likely to receive ongoing antibacterial drug prophylaxis after treatment of cUTI (e.g., subjects with vesico-ureteral reflux);
✕. Suspected or confirmed prostatitis;
✕. Requirement for bladder irrigation with antibiotics or for antibiotics to be administered directly via urinary catheter;
✕. Previous or planned cystectomy or ileal loop surgery;
✕. Uncomplicated urinary tract infection (for example, female subjects with urinary frequency, urgency or pain or discomfort without systemic symptoms or signs of infection);