“If approved, sulopenem will help address the significant clinical and economic need for new oral antibiotics that enable the effective treatment of resistant pathogens in the community, make possible the avoidance of hospitalization, and facilitate early hospital discharge by providing continuity-of-care step-down therapy,” the company said in the statement. 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. Please remove one or more studies before adding more. Patient has any finding that, in the view of the Investigator, would compromise the patient's safety requirements. 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. Iterum Therapeutics maintaining business operations amid COVID-19 public health crisis . “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. Condition, Keyword, or NCT Number. 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. Patient has presence of Endocarditis, Meningitis, Necrotizing fasciitis, or Gas gangrene, Patient has evidence of active liver disease or hepatic dysfunction. 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. Choosing to participate in a study is an important personal decision. Listing a study does not mean it has been evaluated by the U.S. Federal Government. U.S. Department of Health and Human Services. The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Urinary retention in men possibly due to benign prostatic hypertrophy vii. Up to 10% of women have a urinary tract infection in a given year and 50% of all women experience at least one UTI at some point in their lives [1]. In addition, this agent is fairly stable … Information provided by (Responsible Party): This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults. This multi-center, double-blind clinical trial is measuring efficacy, tolerability, and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women. Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures. Search for Clinical Trials by condition, keyword or trial number. Patient must have sufficient venous access to permit administration of study drug, collection of PK samples, and monitoring of laboratory safety variables. Complicated UTI as defined by one or more of the following factors: Dysuria, urinary frequency or urinary urgency, Costovertebral angle tenderness on physical examination, a dipstick analysis positive for nitrite AND, evidence of pyuria as defined by either: i. a dipstick analysis positive for leukocyte esterase AND/OR ii. Choosing to participate in a study is an important personal decision. Sulopenem is being evaluated in phase 3 clinical trials for uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections. Search. 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 Oral and IV sulopenem are being evaluated in pivotal Phase 3 clinical trials for uncomplicated urinary tract infections, complicated urinary tract infections … UTIs are among the most common bacterial infections encountered in the community. Female patients who are post-menarche must not be pregnant or breast feeding and must have a documented negative serum pregnancy test at Screening. 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 Talk with your doctor and family members or friends about deciding to join a study. Patient is unable to tolerate oral medications. Iterum Therapeutics Provides Update on Phase 3 Clinical Trials of Sulopenem in Complicated Urinary Tract Infection (cUTI) and Uncomplicated Urinary Tract Infection (uUTI) Download as PDF. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics, International Limited. Patients are randomized to receive either oral sulopenem/probenecid twice daily for 5 days of treatment, or oral ciprofloxacin twice daily for three days of treatment. 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 … The FDA has granted Special Protocol Agreements and Qualified Infectious Disease Product designations for sulopenem. This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment … You have reached the maximum number of saved studies (100). Patient has neutropenia with absolute neutrophil count <500 cells/mm3. 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. Neurogenic bladder iv. Patient has creatinine clearance <90 mL/min using the Cockcroft-Gault formula. Location . Indication. Read our, ClinicalTrials.gov Identifier: NCT03357614, Interventional history of prior UTI due to Pseudomonas species, recent steroid use, others), Recent trauma to the pelvis or urinary tract within the prior 30 days, Patients with a history of blood dyscrasias, Patients with a history of uric acid kidney stones. Datum és verzió: 04June2018 For general information, Learn About Clinical Studies. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 7 Pharmacology and Biochemistry. Oral and IV sulopenem are being evaluated in pivotal Phase 3 clinical trials of uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. 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. 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 ]. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Patient has known allergies to penicillin, carbapenems, and/or cephalosporins, known allergy to probenecid, or severe allergic reactions to any drug in the past. 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. During treatment, pharmacokinetic samples will be collected and patients will be monitored for safety and tolerability. Sulopenem intravenous 1000 mg (single dose) on Day 1 followed by oral sulopenem etzadroxil/probenecid 500 mg/500 mg (single dose) on Day 2. sulopenem intravenous 1000 mg on Day 1 and then sulopenem etzadroxil/probenecid oral 500 mg/500 mg on Day 2, Maximum plasma concentration (Cmax) of sulopenem at multiple timepoints after dose, Time to maximum plasma concentration (Tmax) of sulopenem at multiple timepoints after dose, Time above minimum inhibitory concentration (MIC) at multiple timepoints after dose, Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable plasma concentration at multiple timepoints after dose, Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity at multiple timepoints after dose, Percentage of area under the concentration-time curve (AUC) extrapolated at multiple timepoints after dose, Terminal elimination half-life at multiple timepoints after dose, Total body clearance for intravenous administration at multiple timepoints after intravenous dose, Apparent total body clearance for oral administration at multiple timepoints after oral dose, Volume of distribution for intravenous administration at multiple timepoints after intravenous dose, Apparent volume of distribution for oral administration at multiple timepoints after oral dose. Why Should I Register and Submit Results? Iterum was founded with one over-arching goal: to develop an antibiotic that addresses the growing crisis of multi-drug-resistant pathogens and meets the specific needs of physicians, their patients and other important stakeholders. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine AND/OR iii. Given this achievement, we reiterate our expectation of announcing top-line data from all three trials in the second half of 2019 and U.S. regulatory submissions by the end of 2019. Among the most important demands were new treatments for common, often serious conditions, including urinary tract infections (UTI), and intra-abdominal infections (IAI). Patient has a diagnosis of uUTI, cUTI, AP, or cIAI as documented by the treating physician. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Iterum Therapeutics, International Limited. 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. Obstructive uropathy due to nephrolithiasis, tumor or fibrosis v. Azotemia due to intrinsic renal disease vi. 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. Sulopenem is a parenteral thiopenem with broad-spectrum antibacterial activity against most gram-positive and gram-negative bacteria. Topline results from uUTI and cUTI clinical trials to be announced in Q2 2020. Surgically modified or abnormal urinary tract anatomy.  (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. Advanced Search. Clinicia… Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357614. 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. patients with chronic vesiculo-ureteral reflux). (eg,. Sulopenem is under investigation in clinical trial NCT03357614 (Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults). 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 … Explore 372,291 research studies … Patient had treatment in the previous 3 months with any drug known to have a well-defined potential for hepatotoxicity (eg, halothane). After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. 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. 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. Patient has involvement in the planning and/or conduct of this study. ... 6.1.2 EU Clinical Trials Register. Sulopenem is Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant infections. Patient has history of intolerance to β-lactam antibiotics, including but not limited to a history of clinically significant diarrhea/loose stools. Help. EU Clinical Trials Register 7 Pharmacology and Biochemistry 7.1 Pharmacology Sulopenem is a parenteral thiopenem with broad-spectrum antibacterial activity against most gram-positive and gram-negative bacteria. 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Patient will be hospitalized for urinary tract infection, acute pyelonephritis, or complicated intraabdominal infection for at least 48 hours and be receiving appropriate anti-infective treatment. New Window . Study Description. Patient is male or female adolescent who are ≥12 and <18 years of age. 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. >100 mL of residual urine after voiding iii. Study Design. Information provided by (Responsible Party): The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients. 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. New Window. Clinically documented pyelonephritis or complicated urinary tract infection: i.  (Clinical Trial), A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem and Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection, Saint Louis, Missouri, United States, 63110. Patient has definite or suspected personal history or family history of clinically significant adverse drug reactions. Help. Increasingly, these are caused by pathogens that have evolved resistance to today's antibiotics. Subjects with an organism isolated from the urine within the last year known to be resistant to ertapenem. Patient has history of solid organ transplantation reported at any time. Sulopenem-etzadroxil is a carbapenem antibiotic., combined with probenecid . The SURE-1 clinical trial (uUTIs) demonstrated statistical superiority of oral sulopenem to the widely used comparator, ciprofloxacin, for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with a quinolone non … Patient participating in any other clinical study that involved the administration of an investigational medication at the time of presentation, during the course of the study, or who had received treatment with an investigational medication in the 30 days prior to study enrollment, or had previously been enrolled in this study or had been treated with sulopenem. 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. 7.1 Pharmacology. “We are delighted to begin our first Phase 3 clinical trial for sulopenem early in the third quarter, consistent with our prior guidance. Patient must be willing to follow all study procedures. For general information, Learn About Clinical Studies. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. March 31, 2020. Help. You have reached the maximum number of saved studies (100). 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. The presence of an indwelling catheter ii. * iterum therapeutics provides update on phase 3 clinical trials of sulopenem in complicated urinary tract infection (cuti) and uncomplicated urinary tract infection (uuti) For the study, 1671 women with pyuria, bacteriuria, and signs and symptoms of uUTI were randomized to sulopenem twice daily for 5 days or ciprofloxacin twice daily for 3 days. Sulopenem is not active against Pseudomonas aeruginosa. 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. Talk with your doctor and family members or friends about deciding to join a study. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700787. Based on your search, you may also be interested in. White blood cell count ≥10 cells/high-powered field in urine sediment. EU Clinical Trials Register. Please remove one or more studies before adding more. 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? New Window. 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. Male subjects must agree to use of an effective barrier method of contraception during the study and for 14 days post treatment, Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 3 X Upper Limit of Normal, Total bilirubin > 2 X Upper Limit of Normal, Patients participating in any other clinical study that involved the administration of an investigational medication, Patients unlikely to comply with the protocol, Patients considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness. Bacterial PneumoniaThe Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP) NCT01189487. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. ClinicalTrials.gov Identifier: NCT04700787, Interventional At least two of the following signs or symptoms: Patients known to have a history of liver or kidney disease or neutropenia as defined by the following baseline laboratory criteria: 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 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. 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. During treatment, pharmacokinetic samples will be collected and patients will be monitored for safety and tolerability. Specifically, they wanted to look at the efficacy and safety of the agent and the clinical success of Sulopenem at Test of Cure (TOC) and End of Treatment (EOT). The safety profile of IV sulopenem has been documented in a Phase 2 program. Share your location or enter your city or zip code to find studies near you. Epidemiology. 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. Receipt of effective antibacterial drug therapy for complicated urinary tract infection (cUTI) for a continuous duration of more than 24 hours during the previous 72 hours. Given these results, oral and IV sulopenem are being evaluated in three pivotal Phase 3 clinical trials …