The randomized, multi-center, double-blind SURE 2 clinical trial enrolled 1,395 patients to measure the efficacy, tolerability, and safety of IV and oral sulopenem for the treatment of cUTI in adults. Sulopenem demonstrated superior clinical activity over ciprofloxacin in patients with uncomplicated urinary tract infections (uUTI) with quinolone resistant pathogens, meeting a coprimary end point of the phase 3 SURE1 trial, according to Iterum Therapeutics plc, the manufacturer of the novel oral penem anti-infective compound. Sulopenem is not active against Pseudomonas aeruginosa. Patient has history or presence of GI, hepatic, or renal disease, or other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs. Patients were randomized to receive either oral sulopenem/probenecid twice daily for five days of treatment, or oral ciprofloxacin twice daily for three days of treatment. Obstructive uropathy due to nephrolithiasis, tumor or fibrosis v. Azotemia due to intrinsic renal disease vi. ClinicalTrials.gov Identifier: NCT04700787, Interventional
Sulopenem is Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant infections. White blood cell count ≥10 cells/high-powered field in urine sediment. Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy test result within 24 hours of study entry, are otherwise known to be pregnant, or are currently breastfeeding an infant. Iterum Therapeutics maintaining business operations amid COVID-19 public health crisis . Severe structural or functional urinary tract abnormality responsible for an intractable infection which in the opinion of the investigator would require > 10 days of therapy or post-treatment prophylaxis (eg. Condition, Keyword, or NCT Number. Explore 372,291 research studies … New Window . The following day, patients will receive a single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. Hypotension with systolic blood pressure < 90 mm Hg, Complicated UTI associated with complete obstruction, emphysematous pyelonephritis, known or suspected renal or perinephric abscess or expected to require surgical intervention (not placement of catheters) to achieve cure, Patients with a known history of myasthenia gravis, Patients who require concomitant administration of tizanidine or valproic acid, Patients with a history of allergy to carbapenems or quinolones or amoxicillin-clavulanate or other beta-lactams, or hypersensitivity to probenecid, High risk for cUTI caused by Pseudomonas sp. New Window. This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Female patients who are post-menarche must not be pregnant or breast feeding and must have a documented negative serum pregnancy test at Screening. The randomized, multi-center, double-blind SURE1 clinical trial enrolled 1,670 patients to measure efficacy, tolerability, and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women. UTIs are among the most common bacterial infections encountered in the community. After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Sulopenem Etzadroxil is an orally available ester prodrug form of sulopenem, a thiopenem with broad-spectrum antibacterial activity against most gram-positive and gram-negative bacteria.After oral administration of sulopenem etzadroxil, the ester bond is cleaved, releasing active sulopenem. Please remove one or more studies before adding more. Please remove one or more studies before adding more. Help. Datum és verzió: 04June2018 patients with chronic vesiculo-ureteral reflux). Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures. For general information, Learn About Clinical Studies. Patient has a diagnosis of uUTI, cUTI, AP, or cIAI as documented by the treating physician. Patients who have objective documentation of clinical progression of cUTI while on antibacterial drug therapy, or patients who received antibacterial drugs for surgical prophylaxis and then develop cUTI, may be appropriate for enrollment. Clinically documented pyelonephritis or complicated urinary tract infection: i. Patient's parent/both parents or guardian must provide written informed consent and a statement of assent from the adolescent patient (if required by Institutional Review Board [IRB] according to local regulations and guidelines) must be obtained prior to any study-related procedures. * iterum therapeutics provides update on phase 3 clinical trials of sulopenem in complicated urinary tract infection (cuti) and uncomplicated urinary tract infection (uuti) EU Clinical Trials Register. Iterum Therapeutics Announces Topline Results from Phase 3 Clinical Trial of Oral and IV Sulopenem for the Treatment of Complicated Intra-abdominal Infections: Sep 19, 2018: Iterum Initiates SURE 2 and SURE 3 Phase 3 Clinical Trials of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections Hospitalized patients who are 12-18 years of age and who are receiving background antibiotic treatment for uncomplicated urinary tract infection, complicated urinary tract infection, acute pyelonephritis, or complicated intraabdominal infection, and who meet eligibility requirements will receive a single 1000 mg IV dose of sulopenem on Day 1. Why Should I Register and Submit Results? Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700787. Help. Patient has involvement in the planning and/or conduct of this study. Patient has presence of Endocarditis, Meningitis, Necrotizing fasciitis, or Gas gangrene, Patient has evidence of active liver disease or hepatic dysfunction. 7 Pharmacology and Biochemistry. Post-menarchal females and post-pubertal males must agree to use a highly effective method of birth control with partners of childbearing potential throughout the duration of the study and for 1 month following the last dose of study drug. New Window. Location . Patient is male or female adolescent who are ≥12 and <18 years of age. (Clinical Trial), Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Prospective, Phase 3, Randomized, Multi-center, Double-blind, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults, 18 Years and older (Adult, Older Adult), Bellflower, California, United States, 90706, Chula Vista, California, United States, 91911, La Mesa, California, United States, 91942, La Palma, California, United States, 90623, Torrance, California, United States, 90502, Miami Lakes, Florida, United States, 33014, Boston, Massachusetts, United States, 02111, Royal Oak, Michigan, United States, 48073. Based on your search, you may also be interested in. Epidemiology. Talk with your doctor and family members or friends about deciding to join a study. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. This Expanded Access Program will allow clinicians to use sulopenem etzadroxil/probenecid for the treatment of patients with serious or immediately life-threatening complicated urinary tract infection due to quinolone-nonsusceptible uropathogens where there are no satisfactory oral alternatives to use as step-down therapy after receiving an initial course of effective intravenous therapy. “The initiation of these trials, together with SURE 1, which we initiated in early August, means that our entire Phase 3 clinical program for sulopenem is currently underway. Oral and IV sulopenem are being evaluated in pivotal Phase 3 clinical trials for uncomplicated urinary tract infections, complicated urinary tract infections … March 31, 2020. Given these results, oral and IV sulopenem are being evaluated in three pivotal Phase 3 clinical trials … Iterum Therapeutics, International Limited. Patient has participated in any other clinical study where an investigational product was ingested within 30 days or 5 half-lives of the drug (whichever is longer) prior to the current study. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Maximum plasma concentration [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Time to maximum plasma concentration [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Time above minimum inhibitory concentration [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Area under the plasma concentration-time curve from time zero extrapolated to infinity [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Percentage of area under the concentration-time curve extrapolated [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Terminal elimination half-life [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Total body clearance for intravenous administration [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Apparent total body clearance for oral administration [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Volume of distribution for intravenous administration [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ], Apparent volume of distribution for oral administration [ Time Frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose ]. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. ... 6.1.2 EU Clinical Trials Register. The randomized, multi-center, double-blind SURE 2 clinical trial enrolled 1,395 patients to measure the efficacy, tolerability, and safety of IV and oral sulopenem for the treatment of cUTI in adults. Sulopenem-etzadroxil is a carbapenem antibiotic., combined with probenecid . Patient had treatment in the previous 3 months with any drug known to have a well-defined potential for hepatotoxicity (eg, halothane). The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated. The NDA submission includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated with no … The randomized, multi-center, double-blind SURE1 clinical trial enrolled 1,670 patients to measure efficacy, tolerability, and safety of oral sulopenem/probenecid for the treatment of uUTI in … This study will be conducted within the context of an ongoing Phase 3 sulopenem clinical trial in order to generate confirmatory data for the population PK profile of both the IV and oral pro-drug regimens of sulopenem. Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment, Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment, Clinical success is defined as complete resolution of cUTI symptoms present at study entry and no new cUTI symptoms; microbiologic success is defined as eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL), Microbiologic success is defined as demonstrating <1000 CFU/mL of the baseline urpathogen by quantitative urine culture. Indication. Sulopenem is being evaluated in phase 3 clinical trials for uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections. You have reached the maximum number of saved studies (100). Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Percentage of Participants With Overall Success [ Time Frame: Day 21 +/- 1 day ], Percentage of Participants With Microbiologic Success [ Time Frame: Day 21 +/- 1 day ], Adults ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI.
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