ID Week - 2018
ID Week - 2018
Unveiling plea CT Results Globally
VRL proudly announce to present results of plea Clinical Trial studies of its flagship product ELORES at IDWeek™ 2018, to be held on October 3-7, 2018, in San Fancisco, CA. We are happy to share that our four abstracts have been accepted for poster presentations at the IDWeek 2018. These posters will cover the plea clinical trial safety and efficacy results, as well as supportive in vitro data on Elores (A novel patented “Antibiotic Adjuvant Entity”)
Elores is a novel combination of Ceftriaxone (third generation beta-lactam cephalosporin), Sulbactam (beta-lactamase inhibitor) and Disodium EDTA (Class 1 Antibiotic Resistance Breaker). It enhances and restores the in vitro activity of Ceftriaxone against ESBL/MBL producing gram-negative bacteria, including enzyme families that belong to Ambler class A (TEM, SHV, CTX-M), class B (NDM, VIM, IMP), class C (some variants of AmpC), and class D (OXA ESBLs).
The plea Clinical trial was a multicenter, randomized, double-blind Phase 3 trial designed to evaluate the safety and efficacy of ELORES (Ceftriaxone+ Sulbactam+ EDTA) for the treatment of complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP) versus Meropenem. The results of the plea Clinical Trial studies include analysis of the primary outcomes which are according to FDA & EMA guidelines (defined as clinical cure plus microbiologic eradication at the test-of-cure visit) based upon molecular strain typing of beta – Lactamase (ESBL and MBL) producing Gram Negative bacterial pathogens in both treatment arms.
The plea trial is India's first clinical trial of such design and VRL is proud to be the first Indian company to have conducted this study and present the results at the world's largest infectious diseases event, IDWeek. We believe that this will further India's research ecosystem and help in putting Indian research on the global research landscape.
The title and description of each poster and presentation times are noted below.
1. Abstract 71511
Session: Novel Agents
Session Date: Friday, October 5, 2018
Session Time: 12:30 PM - 1:45 PM
Session Location: Moscone Convention Center Hall C (entrance via IDExpo Hall A)
Presentation Title: Activity of Ceftriaxone-Sulbactam-EDTA Against Multi-Drug Resistant A. baumannii, P. aeruginosa and Enterobacteriaceae Isolates (WHO Critical Priority Pathogens) Collected from Various Hospitals in India
2. Abstract 70696
Session:Clinical Trials
Session Date: Saturday, October 6, 2018
Session Time: 12:30 PM - 1:45 PM
Session Location: Moscone Convention Center Hall C (entrance via IDExpo Hall A)
Presentation Title: Ceftriaxone-Sulbactam-EDTA vs. Meropenem in PLEA (a Phase 3, Randomized, Double-blind Trial): Outcomes by Baseline MIC in Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis
3. Abstract 69894
Session:Clinical Trials
Session Date: Saturday, October 6, 2018
Session Time: 12:30 PM - 1:45 PM
Session Location: Moscone Convention Center Hall C (entrance via IDExpo Hall A)
Presentation Title: Ceftriaxone-Sulbactam-EDTA (CSE) vs. Meropenem (MR) in PLEA (a Phase 3, Randomized, Double-blind Trial): Outcomes in Patients Infected with Ceftriaxone Non-Susceptible, Extended Spectrum Beta-Lactamase and Multi-Drug Resistant Pathogens at Baseline
4. Abstract 70988
Session:Clinical Trials
Session Date: Saturday, October 6, 2018
Session Time: 12:30 PM - 1:45 PM
Session Location: Moscone Convention Center Hall C (entrance via IDExpo Hall A)
Presentation Title: Ceftriaxone-Sulbactam-EDTA vs. Meropenem: Analysis of failed patients with assessment of MIC increases and changes in genotypic profile in PLEA (a Phase 3, Randomized, Double-blind Clinical Trial in Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis)
The posters will be made available on the company’s website following their presentation at the conference.
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Unveiling plea CT Results Globally