zoliflodacin phase 3

Gonorrhoea is a common sexually transmitted infection (STI) affecting both men and women, particularly between 15 and 24 years old. "The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhoea program. "The initiation of the phase 3 trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Efficacy of a single dose of zoliflodacin will be assessed compared to a combination of a single dose of ceftriaxone and azithromycin. Zoliflodacin is a novel, first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhoea. You can unsubscribe at any time and we'll never share your details to third parties. GARDP has commercial rights to zoliflodacin in up to 168 low- and select middle-income countries, while Entasis retains commercial rights in the rest of the world. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five half-lives of the drug, whichever is greater, prior to screening, Cytotoxic or radiation therapy within 30 days prior to screening, Known chronic renal, hepatic, hematologic impairment or other condition interfering with the absorption, distribution or elimination of the drug based on medical history and physical examination, History of urogenital sex-reassignment surgery, Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count <200 cells/μL, Know clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation, Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics, Known or suspected allergies or hypersensitivities to lidocaine, methylparaben, lactose or any of the components of the study drugs (refer to the zoliflodacin IB and SmPC for the comparators treatments), Receipt or planned receipt of an investigational product in a clinical trial within 30 days or five half-lives of the drug, whichever is greater, prior to screening until end of participation to this clinical trial, History of alcohol or drug abuse within 12 months prior to screening which would compromise trial participation in the judgment of the investigator, Severe medical or psychiatric condition which, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of trial results or affect the individual's ability to provide informed consent, Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol. Phase 3 clinical development program of zoliflodacin •Phase 2 study has completed enrollment •Licensure in the US and in the EU will require a single Phase 3 study –Approximately 600 patients –Approximately 18-24 months from first patient enrolled to final … This QC range will be used for in vitro susceptibility testing of zoliflodacin during phase 3 human clinical trials and surveillance studies, and eventually it will be implemented in clinical labs. [ Time Frame: Day 2 ], Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and thics guidance), Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture), For females of child-bearing potential, a negative urine pregnancy test at screening. About Zoliflodacin Zoliflodacin is a novel oral antibiotic for the treatment of uncomplicated gonorrhea and the first of a novel class of molecules to be developed for this indication. Participant in this arm will receive a single dose of zoliflodacin. You have reached the maximum number of saved studies (100). Our data support the initiation of the global zoliflodacin phase 3 randomized controlled clinical trial for uncomplicated gonorrhea. This single pivotal trial is a multi-center, open-label, randomized, controlled, non-inferiority, phase 3 trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin, compared to a single intra-muscular dose of 500 mg ceftriaxone combined with a single oral dose of 1 g azithromycin, which is standard of care for the treatment of uncomplicated Neisseria gonorrhoeae (NG) infection. [2] Science X Daily and the Weekly Email Newsletter are free features that allow you to receive your favorite sci-tech news updates in your email inbox, Novel antibiotic shows promise in treatment of uncomplicated gonorrhea, On the hunt for a dengue antiviral: Scientists comb through scores of compounds to find a drug for 'breakbone fever', Neuroscientists identify brain circuit motifs that support short-term memory, Study offers new insight about gene expression and neurological disease heritability, Gene therapy overcomes mutation problems in cystic fibrosis, Researchers identify a class of neurons that are most active during non-REM sleep. Females on oral contraceptives must also use a barrier contraception method during participation in the study. Click here to sign in with We do not guarantee individual replies due to extremely high volume of correspondence. This site uses cookies to assist with navigation, analyse your use of our services, and provide content from third parties. Our partnership with Entasis is critical for preventing the dire scenario of untreatable gonorrhea and controlling this infection,” said Dr. Manica Balasegaram, Executive Director of GARDP. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Zoliflodacin was well tolerated, with mostly limited transient gastrointestinal side effects. Our partnership with Entasis is critical for preventing the dire scenario of untreatable gonorrhea and controlling this infection,” said Dr. … Of the 141 evaluable participants, a microbiologic cure at urogenital sites was observed 55/57 (96.5%) of those in the 2 g zoliflodacin group, 54/56 (96.4%) in the 3 g zoliflodacin group, and 28/28 (100%) who received ceftriaxone. "The initiation of the phase 3 trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). Zoliflodacin Was Well-Tolerated and Successfully Treated Substantially All Uncomplicated Gonorrhea Cases. Phase 3 clinical trial, in partnership with GARDP, to begin in 2019 „Die phase-3-Studie von zoliflodacin markiert die Letzte große klinische Studie für unser Gonorrhoe Programm. "The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhoea program. Information provided by (Responsible Party): This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea. Data from the phase 3 clinical trial is anticipated in 2021. In July 2017, Entasis partnered with the Global Antibiotic Research and Development Partnership (GARDP) to co-develop zoliflodacin through Phase 3. In partnership with GARDP, zoliflodacin is currently being studied in a global Phase 3 clinical trial. Global Antibiotic Research & Development Partnership. It is expected to begin Phase 3 testing in the Netherlands, South Africa, Thailand and the United States next year. Daily science news on research developments and the latest scientific innovations, The latest engineering, electronics and technology advances, The most comprehensive sci-tech news coverage on the web. Willingness and ability to give written informed consent or be consented by a legal representative or provide assent and parental consent (for minors, as appropriate). Entasis' partnership with GARDP reflects our commitment to enable global access of this potential novel oral treatment for a disease that is quickly becoming resistant to all currently available antibiotics," said Manos Perros, Ph.D., President and Chief Executive Officer of Entasis Therapeutics. Apart from any fair dealing for the purpose of private study or research, no Data from the phase 3 clinical trial is anticipated in 2021. "The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhoea program. Entasis, in partnership with GARDP, will begin Phase 3 testing of zoliflodacin in the Netherlands, South Africa, Thailand and the United States next year. CT infection), Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening, Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening, Use of moderate or strong CYP3A4 inducers (e.g. Your opinions are important to us. [ Time Frame: Day 6 and Day 30 ], Microbiological cure rate of pharyngeal gonorrhoea will be determined after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 ], Microbiological cure rate of urogenital gonorrhoea will be determined among women and men respectively, after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. It is expected to begin Phase 3 testing in the Netherlands, South Africa, Thailand and the United States next year. This was the second of three clinical trials needed for U.S. approval of zoliflodacin. Proportion of participants with microbiological cure as determined by culture at pharyngeal sites at test of cure visit. The agency already has granted the antibiotic a "fast track" designation. Thank you for taking your time to send in your valued opinion to Science X editors. Patients included in the trial will be randomized (2:1) to receive either zoliflodacin or a combination of ceftriaxone and azithromycin and will be assessed one week later for persistence of the infection. Phase 3 trials will start next year, Taylor said. By using our site, you acknowledge that you have read and understand our Privacy Policy [ Time Frame: Day 6 ], Safety of a single dose of zoliflodacin will be assessed compared to a combination a single dose of ceftriaxone and azithromycin. "The initiation of the phase 3 trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. [ Time Frame: Day 6 ], Antimicrobial susceptibility profile will be determined of gonococcal strains isolated from participants with uncomplicated gonorrhoea at baseline and the test of cure visit. Globally the infection rate of gonorrhoea is increasing, with 87 million new cases estimated each year. [ Time Frame: Day 6 ], The plasma concentration will be evaluated (included Area Under the Curve (AUC) over 36 hours) after a single dose of zoliflodacin. Similar to the phase 2 study, the phase 3 trial has urogenital infections caused by N. gonorrheae as the criterion for enrollment. That is why there is an urgent need for new treatments and why the World Health Organization is supporting GARDP. New treatment for drug-resistant gonorrhea, Zoliflodacin, to enter global Phase 3 clinical trial. The content is provided for information purposes only. Previous randomisation in this clinical trial. "The initiation of the phase 3 trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. Biopharmaceutical company Entasis Therapeutics and the nonprofit Global Antibiotic Research and Development Partnership (GARDP) today announced the initiation of a global phase 3 clinical trial for zoliflodacin, a new antibiotic for treating uncomplicated gonorrhea. Entasis’ partnership with GARDP reflects our commitment to enable global access of this potential novel oral treatment for a disease that is quickly becoming resistant to all currently available antibiotics,” said Manos Perros, PhD, President and Chief Executive Officer of Entasis Therapeutics. Proportion of participants with microbiological cure as determined by culture at rectal sites at test of cure visit. Proportion of female and male participants respectively with microbiological cure as determined by culture at cervical or urethral site at test of cure visit. One of them is the Wits Reproductive Health and HIV Institute … For general information, Learn About Clinical Studies. Phase 3 trials will start next year, Taylor said. If those trials go well, the U.S. Food and Drug Administration would have data on hand to evaluate and approve the antibiotic by 2020. All rectal infections were cured in participants who received 2 or 3 g zoliflodacin and ceftriaxone. Zoliflodacin (development codes AZD0914 and ETX0914) is an experimental antibiotic that is being studied for the treatment of infection with Neisseria gonorrhoeae . Talk with your doctor and family members or friends about deciding to join a study. "The global nature of the trial, across four continents, represents our commitment to ensuring this treatment is available to anyone who needs it, wherever they live.". Zoliflodacin has been awarded fast track status by the U.S. Food and Drug Administration for development as oral treatment for gonococcal infections. The Drugs for Neglected Diseases initiative is … The trial was designed to evaluate the safety of zoliflodacin and to inform the decision to proceed to a phase 3 trial. [ Time Frame: Day 6 ], The clinical cure rate of symptomatic gonorrhoea in male participants will be determined after administration of a single dose of zoliflodacin compared to a combination of single dose of ceftriaxone and azithromycin. Gonorrhoea is caused by the bacterium Neisseria gonorrhoeae, which has progressively developed resistance to globally recommended treatments and has been identified by the World Health Organization as among a family of 'priority pathogens' posing the greatest threat to global health. ClinicalTrials.gov Identifier: NCT03959527, Interventional part may be reproduced without the written permission. In the partnership, Entasis retains all commercial rights to zoliflodacin in high-income territories while GARDP receives commercial rights in low- and some middle-income countries. Your feedback will go directly to Science X editors. Zoliflodacin has been awarded fast track status by the U.S. Food and Drug Administration for development as oral treatment for gonococcal infections. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Get weekly and/or daily updates delivered to your inbox. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Dose: 500mg, Intra-Muscular (IM) administration. “The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhoea program. WALTHAM, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced that The New England journal of Medicine (NEJM) published results from a Phase 2 … This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea. Our partnership with Entasis is critical for preventing the dire scenario of untreatable gonorrhoea and controlling this infection," said Dr. Manica Balasegaram, Executive Director of GARDP. Zoliflodacin was highly active in vitro against all tested isolates (MIC range: 0.004-0.25; MIC50: 0.064, MIC90: 0.125 μg/ml), with no cross-resistance to any of the seven comparator antimicrobials. This was the second of three clinical trials needed for U.S. approval of zoliflodacin. “The global nature of the trial, across four continents, represents our commitment to … or, by Global Antibiotic Research & Development Partnership. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The Global Antibiotic Research and Development Partnership (GARDP), a not for profit organisation developing new treatments for drug resistant infections, and Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today jointly announced the initiation of a global phase 3 pivotal trial of zoliflodacin. and Terms of Use. The phase 3 trial initiation marks an important milestone for this novel industry and non-profit partnership in jointly developing a novel antibiotic and building a strategic plan for successful market access within the countries that have high rates of gonorrhoea and for patients who need it most. Uncomplicated gonorrhoea infections carry high morbidity, enhance transmission of other sexually transmitted diseases and are highly stigmatized. Phase 3 clinical trial, in partnership with GARDP, to begin in 2019. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959527. The trial is expected to enrol approximately 1,000 adults with urogenital gonorrhoea from clinical trial sites in the United States, Netherlands, Thailand and South Africa. Zoliflodacin Was Well-Tolerated and Successfully Treated Substantially All Uncomplicated Gonorrhea Cases. Phase 3 trial for new gonorrhea antibiotic to launch. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The compound, which has been granted qualified infectious disease product status and fast track designation by the U.S. Food and Drug Administration, has successfully completed both phase I ( 3) and phase 2 ( 4) clinical studies, and phase 3 testing will begin in 2019. [ Time Frame: Day 6 ], Microbiological cure rate of Neisseria gonorrhoeae (NG) at urogenital sites will be determined. At the same time, we are observing increasing resistance to the last line-options for treatment in Neisseria gonorrhoeae. Zoliflodacin is a novel, first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhoea. ", "The initiation of the phase 3 trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. You can be assured our editors closely monitor every feedback sent and will take appropriate actions. This is an open-label trial comparing a single 3 g oral dose of zoliflodacin to a combination of ceftriaxone and azithromycin (2:1 randomization). "We both believe a solution lies with an oral treatment option, which not only overcomes existing resistance but also offers significant benefits compared to the current standard of care of one or more intramuscular injections. Please remove one or more studies before adding more. U.S. Department of Health and Human Services. Your email address is used only to let the recipient know who sent the email. Microbiological cure as determined by culture at urethral or cervical sites at test of cure visit. Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of the drug, whichever is greater, prior to screening. Antimicrobial susceptibility profile of gonococcal strains isolated at baseline and at test of cure visit. Three sites across two provinces in South Africa are set to take part in the study. We look forward to continuing our relationship with GARDP as we progress this global phase 3 trial.". South Africa is one of four countries which is involved in a global phase 3 trial to assess the efficacy and safety of zoliflodacin, a new treatment for gonorrhoea, against standard treatments. [ Time Frame: Day 6 ], The eradication rate of NG nucleic acid will be determined from urogenital rectal, pharyngeal specimens after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. 23 In partnership with the Global Antibiotic Research and Development Partnership (GARDP), an international Phase 3 RCT to evaluate the efficacy and safety of zoliflodacin for treatment of uncomplicated gonorrhoea was initiated in 2019. Proportion of male participants with clinical cure at test of cure visit. Five PK timepoints post-treatment will be assessed. Choosing to participate in a study is an important personal decision. Provided by Phase 3 clinical trial, in partnership with GARDP, to begin in 2019 Why Should I Register and Submit Results? Proportion of participants with a negative NG NAAT from urethral or cervical, oropharyngeal and rectal sites at test of cure visit. Neither your address nor the recipient's address will be used for any other purpose. However, the presence of extraurogenital infections will also be studied as a secondary end point in the hope that this data will … South Africa Participating in Phase 3 Zoliflodacin Trial. [ Time Frame: Day 6 ], Microbiological cure rate of rectal gonorrhoea will be determined after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. GARDP is partnering with Entasis Therapeutics to complete late-stage development, with GARDP fully-funding and sponsoring the global phase 3 trial. For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment, Willingness to comply with trial protocol, Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex until end of trial visit, Confirmed or suspected complicated or disseminated gonorrhoea, Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. It has a novel mechanism of action which involves inhibition of bacterial type II topoisomerases . Global Antibiotics Research and Development Partnership. This document is subject to copyright. Study record managers: refer to the Data Element Definitions if submitting registration or results information.  (Clinical Trial), Single dose of Zoliflodacin or comparators combination in single dose: ceftriaxone and azithromycin, A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea, Active Comparator: ceftriaxone and azithromycin combination, 12 Years and older   (Child, Adult, Older Adult), Birmingham, Alabama, United States, 35294-0006, San Francisco Department Of Public Health City Clinic, San Francisco, California, United States, 94103, Indianapolis, Indiana, United States, 46202, Louisiana State University Health Sciences Center, New Orleans, Louisiana, United States, 70112, Public Health - Seattle & King County STD Clinic, Seattle, Washington, United States, 98104, Public Health Service (GGD) Amsterdam / STI Outpatient Clinic, SAMRC Botha's Hill Clinical Research Site, Bangrak STI Center at Bangklo Branch Department of MTB, Bangrak STI Center at Rat Pracha Samasai Institute. Entasis has a second program, gyrase-inhibitor zoliflodacin, that is also set to enter phase 3 next year. Teodora Wi, WHO Medical Officer for STIs, said: "Gonorrhoea rates are increasing, resulting in substantial morbidity and a huge psychosocial and economic cost worldwide. Under the partnership agreement, GARDP is responsible for the phase 3 trial and pharmaceutical development activities for zoliflodacin to support regulatory approval and market access and availability. Data from the phase 3 clinical trial is anticipated in 2021. Following positive phase 2 results previously published in the New England Journal of Medicine (NEJM), Entasis and GARDP have partnered to complete late stage development, with GARDP fully-funding and sponsoring the global phase 3 trial. Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at the test of cure visit and for whom the baseline antimicrobial susceptibility profile indicated pre-existing resistance to antibiotics commonly used for Neisseria gonorrhoeae (NG) treatment.
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