etx2514 clinical trial
(Clinical Trial). 18 Jan 2021. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Information provided by (Responsible Party): This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC (Acinetobacter baumannii-calcoaceticus Complex) hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. You have reached the maximum number of saved studies (100). ETX2514 has completed single- and multi-ascending dose Phase 1 trials and a Phase 2 trial, in combination with sulbactam, in complicated urinary tract infections. The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A. ETX2514 has completed single- and multi-ascending dose Phase 1 trials and a Phase 2 trial, in combination with sulbactam, in complicated urinary tract infections. Study drugs will not be masked due to logistical reasons, every attempt will be made to maintain the blind for patients, all staff at the site, and the Sponsor or its designees, except for the treatment physician and other immediate healthcare providers. Why Should I Register and Submit Results? About the Phase I Clinical Trial The Phase I study is a double-blind, randomized, placebo-controlled study of ETX2514 in healthy subjects. doi: 10.1128/AAC.01506-19. About Entasis ETX2514 has completed single- and multi-ascending dose Phase 1 trials and a Phase 2 trial, in combination with sulbactam, in complicated urinary tract infections. Choosing to participate in a study is an important personal decision. Acinetobacter baumannii is a gram-negative bacterium known to cause severe infections and exhibit increasing rates of antibiotic resistance. Male or female, 18 to 90 years of age, inclusive. It has announced the initiation of Phase 1 clinical study of ETX2514. Cohort 15- 1g* IV ETX2514/ placebo plus 1g sulbactam infused over 3 hours plus 0.5g IV primaxin infused over 30 minutes at the same time, every 6 hours (4 times a day) for 10 consecutive days and 1 dose on Day 11 to participants aged 18-55 *The actual ETX2514 dose and infusion time studied in Part D will be determined based on PK and safety data from Part A. Clinical Trial Results: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis. This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs. Sagan O, Yakubsevitch R, Yanev K, Fomkin R, Stone E, Hines D, O'Donnell J, Miller A, Isaacs R, Srinivasan S. Pharmacokinetics and Tolerability of Intravenous Sulbactam-Durlobactam with Imipenem-Cilastatin in Hospitalized Adults with Complicated Urinary Tract Infections, Including Acute Pyelonephritis. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: CRABC m-MITT (Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex Microbiologically Modified Intent-to-Treat Population) [ Time Frame: 28 Days ], MITT (Modified Intent To Treat population containing all patients who received any amount of study drug) [ Time Frame: 28 days ]. The trial is being conducted in Australia and is expected to be completed in the first half of 2017. Please remove one or more studies before adding more. Thomas F. … The study is designed to evaluate the safety, tolerability, and pharmacokinetics of ETX2514 alone and in combination with sulbactam. About EntasisEntasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug … Clinical Trials. 1. ETX2514 has completed single- and multi-ascending dose Phase 1 trials and a Phase 2 trial, in combination with sulbactam, in complicated urinary tract infections. Listing a study does not mean it has been evaluated by the U.S. Federal Government. clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. Although several new β-lactamase inhibitors have been approved or are in clinical trials, their spectra of activity do not address MDR pathogens such as Acinetobacter baumannii. Any patients previously randomized in this study. U.S. Department of Health and Human Services. The trial is being conducted in Australia and is expected to be completed in the first half of 2017. WALTHAM, Mass. All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. Listing a study does not mean it has been evaluated by the U.S. Federal Government. ETX2514 has completed single- and multi-ascending dose Phase 1 trials and a Phase 2 trial, in combination with sulbactam, in complicated urinary tract infections. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445195. More information about this clinical trial is available at the Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12616000995471). Patient requires continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study. About the Phase I Clinical Trial The Phase I study is a double-blind, randomized, placebo-controlled study of ETX2514 in healthy subjects. Has received no more than 48 hours of effective empiric therapy prior to enrollment; OR b. Choosing to participate in a study is an important personal decision. ETX2514 has completed single- and multi-ascending dose Phase 1 trials. About Zai Lab Listing a study does not mean it has been evaluated by the U.S. Federal Government. Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex (ATTACK) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 2020 Feb 21;64(3). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Has an infection caused by ABC organisms known to be resistant to colistin (defined as. Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects. The study will evaluate the safety, tolerability and pharmacokinetics of ETX2514 in healthy volunteers. Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections. Most Read. Clinical Trial Results: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Our pipeline consists of clinical and pre-clinical pathogen-targeted small-molecule antibacterials for the treatment of multidrug-resistant Gram-negative bacteria, such as Pseudomonas aeruginosa, Acinetobacter baumanii, carbapenem-resistant Enterobacteriaceae, and … Requirement at time of randomization for any reason for additional systemic antimicrobial therapy (including antibacterial, antimycobacterial, or antifungal therapy) other than study drug, with the exception of a single oral dose of any antifungal treatment for vaginal candidiasis. Has acute kidney injury and is receiving renal replacement therapy at study entry. ETX2514 has completed single- and multi-ascending dose Phase 1 trials and a Phase 2 trial, in combination with sulbactam, in complicated urinary tract infections. Is clinically failing prior treatment regimens, Expectation, in the judgment of the Investigator, that the patient will survive at least 72 hours with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study. The clinical trial will be conducted in Australia (124 volunteers) and is expected to be completed in the first half of 2017. Receipt of a single dose of a long-acting, potentially-effective systemic antibiotic with activity against Gram-negative uropathogens for more than 24 hours within the 72-hour window prior to randomization. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. Male participants must be willing to use condoms during sexual intercourse from Screening until at least 90 days after administration of the last dose of study drug. ETX2514/1.0 g sulbactam IV infused every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused every 6 hours(q6h). The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The primary safety endpoint for the study is the incidence of nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A. Acinetobacter Baumannii-calcoaceticus Complex, Ventilator-associated Bacterial Pneumonia, Drug: ETX2514/Sulbactam + Imipenem/Cilastin. ... Active-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter baumannii-calcoaceticus Complex: A.3.1: Title of the trial for lay people, in easily understood, i.e. Please remove one or more studies before adding more. Talk with your doctor and family members or friends about deciding to join a study. pii: e01506-19. and SHANGHAI, April 25, 2018 – Entasis Therapeutics Holdings Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial … Entasis plans to initiate a Phase 3 clinical trial focusing on carbapenem-resistant Acinetobacter baumannii infections in the first quarter of 2019. Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the patient's participation in the study [from randomization through the Late Follow-up (LFU) Visit]. (Clinical Trial). ETX2514 has completed single- and multi-ascending dose Phase 1 trials and a Phase 2 trial, in combination with sulbactam, in complicated urinary tract infections. For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. The U.S. Food and Drug Administration has granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to ETX2514SUL for the treatment of hospital-acquired and ventilator-acquired bacterial pneumonia and bloodstream infections due to A. baumannii. This study will be conducted to determine the routes and rates of excretion of radio label arising from 14C-ETX2514 and to characterize metabolites of ETX2514 arising from 14C-ETX2514 administered intravenously in healthy participants.. Clinical Trials Registry.