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. 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). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. More information about this clinical trial is available at the Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12616000995471). Choosing to participate in a study is an important personal decision. 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. Please remove one or more studies before adding more. This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs. Choosing to participate in a study is an important personal decision. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Learn more about the EU Clinical Trials Register including the source of the information and the legal basis. 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. (Clinical Trial). 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. Has a known resistant infection based on evidence from culture and susceptibility OR, Has documented clinical evidence of failure, Has myasthenia gravis or is taking curariform muscle relaxants (eg, tubocurarine) or other drugs that potentiate neuromuscular blocking, including ether, succinylcholine, gallamine, decamethonium, and sodium citrate and, hence, cannot receive colistin; OR. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit. Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), 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, Experimental: Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin, Placebo Comparator: Placebo + Imipenem/Cilastatin, 18 Years to 90 Years (Adult, Older Adult), Universeity Multiprofile Hospital for Active Teatment, University Multiprofile Hospital for Active Teatment-Clinic of Nephrology, Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov, Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie. 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. 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. pii: e01506-19. 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. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Read our disclaimer for details. Print 2020 Feb 21. Most Read. clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894046. (Clinical Trial). ETX2514 has completed single- and multi-ascending dose Phase 1 trials and a Phase 2 trial, in combination with sulbactam, in cUTI. For general information, Learn About Clinical Studies. You have reached the maximum number of saved studies (100). The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h. Gross hematuria requiring intervention other than administration of study drug or removal or exchange of a urinary catheter. Acinetobacter baumannii is a gram-negative bacterium known to cause severe infections and exhibit increasing rates of antibiotic resistance. 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. 18 Jan 2021. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). U.S. Department of Health and Human Services. 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. Investment firm GI Partners closes Clinical Ink acquisition; Investment firm GI Partners to acquire minority interest in Clinical Ink; IVI and SNU partner to trial Inovio’s Covid-19 vaccine in Korea ; Most Recent. 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. Collaboration will facilitate enrollment of pivotal global Phase 3 trial of ETX2514 in combination with sulbactam for the treatment of carbapenem-resistant Acinetobacter baumannii infections 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. Entasis plans to initiate a Phase 3 clinical trial focusing on carbapenem-resistant Acinetobacter baumannii infections in the first quarter of 2019. 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. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii (a type of bacteria) infections, this project will also look at whether ETX2514 will interact with the current treatments for these infections when they are administered at the same time.. Clinical Trials … Preliminary results from Aldeyra’s Phase III TRANQUILITY trial offer promise for patients with dry eye syndrome. 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. Entasis Therapeutics has initiated the pivotal Phase III ATTACK clinical trial of ETX2514SUL to treat pneumonia and bloodstream infections caused due to carbapenem-resistant Acinetobacter baumannii. Collaboration will facilitate enrollment of pivotal global Phase 3 trial of ETX2514 in combination with sulbactam for the treatment of carbapenem-resistant Acinetobacter baumannii infections. 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 … The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Please remove one or more studies before adding more. Antimicrob Agents Chemother. 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. Documented or suspected cUTI or Acute pyelonephritis (AP). A confirmed diagnosis of a serious infection and the expectation, in the judgment of the Investigator, that the patient's infection will require treatment with IV antibiotics; A known infection caused by ABC (bacteremia, HABP, VABP, cUTI or AP, or surgical or post-traumatic wound infections) as either a single pathogen or member of a polymicrobial infection based on evidence from culture or, if available, rapid diagnostic test from a sample collected within 72 hours prior to randomization (HABP/VABP patients), AND 1 of the following: a. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445195. If a study patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient as permitted by local law and institutional Standard Operating Procedures. 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. 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 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. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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. 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. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of ETX2514 alone and in combination with sulbactam. Male or female, 18 to 90 years of age, inclusive. Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects. About Zai Lab The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. A signed informed consent form (ICF). Expectation, in the judgment of the Investigator, that the patient's cUTI would require initial hospitalization and treatment with IV antibiotics. 2020 Feb 21;64(3). Published: 30 June 2017 ETX2514 is a broad-spectrum β-lactamase inhibitor for the treatment of drug-resistant Gram-negative bacteria including Acinetobacter baumannii. Information provided by (Responsible Party): This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy. 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. A Clinical Trial to Evaluate the Efficacy and Safety of Sulbactam-ETX2514, a New Drug in the Treatment of Patients With ABC Infections Caused by Acinetobacter baumannii-calcoaceticus Complex A.4.1 Sponsor's protocol code number US Clinical Trials Registry Clinical Trials Nct Page Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections. Clinical Trials Nct Page Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers A Randomized, Three Period Crossover Thorough QT (TQT) Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or … The clinical trial will be conducted in Australia (124 volunteers) and is expected to be completed in the first half of 2017. 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. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Number of Participants With Overall Success [ Time Frame: From baseline through day 21 ], Clinical Cure [ Time Frame: Baseline to day 21 ], Microbiologic Eradication [ Time Frame: Baseline to day 21 ]. Any patients previously randomized in this study. 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. About the Phase I Clinical Trial The Phase I study is a double-blind, randomized, placebo-controlled study of ETX2514 in healthy subjects. Dzhanelidze Research Institute Of Emergency Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH), Faculty of Medicine, Chiangmai University, Faculty of Medicine, Khon Kaen University, Bamrasnaradura Infectious Disease Institute, Ankara University Medical Faculty Ibni Sina Research and Application Hospital, Istanbul University Cerrahpasa Medical Faculty, Ege Universitesi Tip Fakultesi - Enfeksiyon Hastaliklari ABD Bornova, Karadeniz Technical University Medical Faculty Farabi Hospital. As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii (a type of bacteria) infections, this project will also look at whether ETX2514 will interact with the current treatments for these infections when they are administered at the same time.. Clinical Trials Registry. Read our disclaimer for details. 1. For general information, Learn About Clinical Studies. Talk with your doctor and family members or friends about deciding to join a study. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of ETX2514 alone and in combination with sulbactam. Part B is the single-group portion of the study and includes ABC infections that are resistant to or have failed colistin treatment. The trial is being conducted in Australia and is expected to be completed in the first half of 2017. Why Should I Register and Submit Results? Listing a study does not mean it has been evaluated by the U.S. Federal Government. About Zai Lab Themes; Deals. 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. Has an infection caused by ABC organisms known to be resistant to colistin (defined as. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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 … ICH GCP. About Entasis Read our, ClinicalTrials.gov Identifier: NCT03445195, Interventional Talk with your doctor and family members or friends about deciding to join a study. 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. The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit. ETX2514 has completed single- and multi-ascending dose Phase 1 trials. doi: 10.1128/AAC.01506-19. and SHANGHAI, April 25, 2018 – Entasis Therapeutics Holdings Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial … 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]. E.E.Volosevich, City Clinical Hospital of Emergency Care #2 - Pulmonary Department, Saint-Petersburg I.I. The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A. It has announced the initiation of Phase 1 clinical study of ETX2514. MIC 4 mg/L by a non-agar based method); For known colistin-resistant infections, the following must be satisfied: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. WALTHAM, Mass. Read our disclaimer for details. Thomas F. … Has received no more than 48 hours of effective empiric therapy prior to enrollment; OR b. ClinicalTrials.gov Identifier: NCT03894046, Interventional A Randomized, 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, 18 Years and older (Adult, Older Adult), Sacramento, California, United States, 95817, Shreveport, Louisiana, United States, 71101, University of Cincinnati (UC) Physicians Company, LLC, University of Tennessee - Elvis Presley Trauma Center, University of Texas Southwestern Medical Center, The University of Texas Health Science Center at Houston, Clínica Dermatológica da Santa Casa de Misericórdia de Belo Horizonte, Santa Casa de Misericórdia de Porto Alegre - Hospital Vicente Scherer, Hospital Universitario Professor Edgard Santos- UFBA, Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Chinese Academy of Medical Sciences & Peking Union Medical College, The First Affiliated Hospital, Chongqing Medical University, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Wenzhou Medical University, Attikon University General Hospital Athens, Sotiria Hospital, General Hospital of Chest Diseases, Regional University General Hospital of Heraklion, General Hospital of Larissa Koutlimpanio & Triantafyllio, AHEPA General University Hospital of Thessaloniki, St. John's National Academy of Health Sciences, K.L.E.S Dr. Prabhakar Kore Hospital and Medical Research Centre, Care Hospital - Department of Critical Care, SMS Medical College & Hospital - Institute of Respiratory Disease, Ruby Hall Clinic - Department of Critical Care Medicine, Hallym University Kangnam Sacred Heart Hospital, Vilnius University Hospital Santaros Klinikos, Hospital Civil de Guadalajara Dr. Juan I. Menchaca, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ), Hospital Universitario "Dr. José Eleuterio González", Hospital Central "Dr Ignacio Morones Prieto", Hospital IV-Alberto Sabogal Sologuren RED asistencial, Hospital Nacional Adolfo Guevara Velasco Cusco, Hospital Nacional Edgardo Rebagliati Martins, Hospital Nacional Cayetano Heredia - Servicio de Medicina Interna, First City Clinical Hospital n.a. “The results from this Phase 1 study demonstrate that ETX2514 is generally safe and well tolerated over the dose range studied and could be co-administered with sulbactam and/or imipenem/cilastatin,” said Robin Isaacs, M.D., Chief Medical Officer of 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. The study will evaluate the safety, tolerability and pharmacokinetics of ETX2514 in healthy volunteers. ICH GCP. ... 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. ETX2514 is a broad and potent inhibitor of class A, C, and D beta-lactamases. This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. 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. 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. About Zai Lab To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Has acute kidney injury and is receiving renal replacement therapy at study entry. Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization that would interfere with evaluation of response to the study antibiotics. The trial is being conducted in Australia and is expected to be completed in the first half of 2017. 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 ]. About the Phase I Clinical Trial The Phase I study is a double-blind, randomized, placebo-controlled study of ETX2514 in healthy subjects. 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. About ETX2514SUL. Clinical Trials. Proportion of patients with a response of clinical cure for the MITT(modified intent to treat), m-MITT (microbiologically modified intent to treat), CE(clinically evaluable), and ME(microbiologically evaluable) populations at the TOC(test of cure) visit. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 2.5 mg/kg colistin IV infused every 12 hours (q12h) plus 1.0 g imipenem/1.0 g cilastatin IV infused every 6 hours (q6h). Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections. All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. Patients with Acute Pyelonephritis may also be enrolled.
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