Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
NCT ID: NCT05584657
Last Updated: 2024-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2229 participants
INTERVENTIONAL
2022-10-18
2023-11-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections
NCT03445195
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
NCT00797108
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
NCT00229021
Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)
NCT01505634
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
NCT04505683
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sulopenem etzadroxil/probenecid
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid
Oral sulopenem twice daily for 5 days
Amoxicillin/clavulanate
Amoxicillin/clavulanate PO twice daily for 5 days
Amoxicillin/clavulanate
Oral Augmentin twice daily for 5 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sulopenem etzadroxil/probenecid
Oral sulopenem twice daily for 5 days
Amoxicillin/clavulanate
Oral Augmentin twice daily for 5 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
* A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine
Exclusion Criteria
* Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
* Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
* Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
* Ongoing urinary retention
* Neurogenic bladder
* Current resident of a long-term care facility
* Instrumentation of urinary tract in the previous 30 days
* An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
* Any history of trauma to the pelvis or urinary tract
* Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
* History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Iterum Therapeutics, International Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sailaja Puttagunta, MD
Role: STUDY_DIRECTOR
Iterum Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Facility
Cullman, Alabama, United States
Medical Facility
Saraland, Alabama, United States
Medical Facility
Sheffield, Alabama, United States
Medical Facility
Peoria, Arizona, United States
Medical Facility3
Phoenix, Arizona, United States
Medical Facility
Phoenix, Arizona, United States
Medical Facility2
Phoenix, Arizona, United States
Medical Facility
Tucson, Arizona, United States
Medical Facility2
Hot Springs, Arkansas, United States
Medical Facility
Hot Springs, Arkansas, United States
Medical Facility
Bakersfield, California, United States
Medical Facility
Chula Vista, California, United States
Medical Facility
Fullerton, California, United States
Medical Facility
Garden Grove, California, United States
Medical Facility
Huntington Beach, California, United States
Medical Facility 2
Huntington Park, California, United States
Medical Facility
Huntington Park, California, United States
Medical Facility
Irvine, California, United States
Medical Facility
La Mesa, California, United States
Medical Facility
Lancaster, California, United States
Medical Facility
Lomita, California, United States
Medical Facility2
Los Angeles, California, United States
Medical Facility
Los Angeles, California, United States
Medical Facility
Pomona, California, United States
Medical Facility
Sacramento, California, United States
Medical Facility
San Diego, California, United States
Medical Facility
Upland, California, United States
Medical Facility
Victorville, California, United States
Medical Facility
Grand Junction, Colorado, United States
Medical Facility
Lakewood, Colorado, United States
Medical Facility
Aventura, Florida, United States
Medical Facility
Boynton Beach, Florida, United States
Medical Facility
Cape Coral, Florida, United States
Medical Facility
Doral, Florida, United States
Medical Facility
Edgewater, Florida, United States
Medical Facility
Hialeah, Florida, United States
Medical Facility
Hollywood, Florida, United States
Medical Facility
Homestead, Florida, United States
Medical Facility
Lake Worth, Florida, United States
Medical Facility2
Lake Worth, Florida, United States
Medical Facility
Leesburg, Florida, United States
Medical Facility3
Miami, Florida, United States
Medical Facility2
Miami, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility9
Miami, Florida, United States
Medical Facility5
Miami, Florida, United States
Medical Facility8
Miami, Florida, United States
Medical Facility6
Miami, Florida, United States
Medical Facility7
Miami, Florida, United States
Medical Facility4
Miami, Florida, United States
Medical Facility
Miami Beach, Florida, United States
Medical Facility
Miami Gardens, Florida, United States
Medical Facility2
Miami Lakes, Florida, United States
Medical Facility
Miami Lakes, Florida, United States
Medical Facility
Orlando, Florida, United States
Medical Facility2
Orlando, Florida, United States
Medical Facility
Ormond Beach, Florida, United States
Medical Facility
Pompano Beach, Florida, United States
Medical Facility
Sweetwater, Florida, United States
Medical Facility
Tamarac, Florida, United States
Medical Facility
Tampa, Florida, United States
Medical Facility3
Tampa, Florida, United States
Medical Facility4
Tampa, Florida, United States
Medical Facility2
Tampa, Florida, United States
Medical Facility5
Tampa, Florida, United States
Medical Facility
Winter Haven, Florida, United States
Medical Facility3
Atlanta, Georgia, United States
Medical Facility2
Atlanta, Georgia, United States
Medical Facility
Atlanta, Georgia, United States
Medical Facility
Decatur, Georgia, United States
Medical Facility
Lawrenceville, Georgia, United States
Medical Facility
Union City, Georgia, United States
Medical Facility
Woodstock, Georgia, United States
Medical Facility
Blackfoot, Idaho, United States
Medical Facility2
Idaho Falls, Idaho, United States
Medical Facility
Idaho Falls, Idaho, United States
Medical Facility
Chicago, Illinois, United States
Medical Facility
Eunice, Louisiana, United States
Medical Facility
Mandeville, Louisiana, United States
Medical Facility
Marrero, Louisiana, United States
Medical Facility
Metairie, Louisiana, United States
Medical Facility
New Orleans, Louisiana, United States
Medical Facility2
New Orleans, Louisiana, United States
Medical Facility
Prairieville, Louisiana, United States
Medical Facility
Shreveport, Louisiana, United States
Medical Facility
Columbia, Maryland, United States
Medical Facility
Oxon Hill, Maryland, United States
Medical Facility
Towson, Maryland, United States
Medical Facility
Fayette, Mississippi, United States
Medical Facility
Gulfport, Mississippi, United States
Medical Facility
Jackson, Mississippi, United States
Medical Facility
Ridgeland, Mississippi, United States
Medical Facility
Great Falls, Montana, United States
Medical Facility
Kalispell, Montana, United States
Medical Facility
Missoula, Montana, United States
Medical Facility2
Las Vegas, Nevada, United States
Medical Facility
Las Vegas, Nevada, United States
Medical Facility2
Albuquerque, New Mexico, United States
Medical Facility
Albuquerque, New Mexico, United States
Medical Facility
Brooklyn, New York, United States
Medical Facility2
Brooklyn, New York, United States
Medical Facility
Garden City, New York, United States
Medical Facility
Schenectady, New York, United States
Medical Facility
The Bronx, New York, United States
Medical Facility
Charlotte, North Carolina, United States
Medical Facility
Greensboro, North Carolina, United States
Medical Facility
New Bern, North Carolina, United States
Medical Facility
Winston-Salem, North Carolina, United States
Medical Facility
Cincinnati, Ohio, United States
Medical Facility2
Columbus, Ohio, United States
Medical Facility
Columbus, Ohio, United States
Medical Facility
Dayton, Ohio, United States
Medical Facility2
Dayton, Ohio, United States
Medical Facility
Lima, Ohio, United States
Medical Facility
Middleburg Heights, Ohio, United States
Medical Facility
Tulsa, Oklahoma, United States
Medical Facility
Eugene, Oregon, United States
Medical Facility
Portland, Oregon, United States
Medical Facility
Beaver, Pennsylvania, United States
Medical Facility
Scottdale, Pennsylvania, United States
Medical Facility
Smithfield, Pennsylvania, United States
Medical Facility
Upper Saint Clair, Pennsylvania, United States
Medical Facility
Charleston, South Carolina, United States
Medical Facility
Easley, South Carolina, United States
Medical Facility
Greenville, South Carolina, United States
Medical Facility
Lancaster, South Carolina, United States
Medical Facility
Myrtle Beach, South Carolina, United States
Medical Facility
Powdersville, South Carolina, United States
Medical Facility
Seneca, South Carolina, United States
Medical Facility
Summerville, South Carolina, United States
Medical Facility2
Chattanooga, Tennessee, United States
Medical Facility
Chattanooga, Tennessee, United States
Medical Facility
Hendersonville, Tennessee, United States
Medical Facility
Memphis, Tennessee, United States
Medical Facility
Nashville, Tennessee, United States
Medical Facility
Austin, Texas, United States
Medical Facility
Carrollton, Texas, United States
Medical Facility2
Carrollton, Texas, United States
Medical Facility
Corpus Christi, Texas, United States
Medical Facility
Dallas, Texas, United States
Medical Facility
Frisco, Texas, United States
Medical Facility
Georgetown, Texas, United States
Medical Facility2
Houston, Texas, United States
Medical Facility
Houston, Texas, United States
Medical Facility
Kingwood, Texas, United States
Medical Facility
League City, Texas, United States
Medical Facility2
McKinney, Texas, United States
Medical Facility
McKinney, Texas, United States
Medical Facility2
Mesquite, Texas, United States
Medical Facility
Mesquite, Texas, United States
Medical Facility
Missouri City, Texas, United States
Medical Facility
Pearland, Texas, United States
Medical Facility2
Plano, Texas, United States
Medical Facility
Plano, Texas, United States
Medical Facility
San Antonio, Texas, United States
Medical Facility 2
Sugar Land, Texas, United States
Medical Facility3
Sugar Land, Texas, United States
Medical Facility
Sugar Land, Texas, United States
Medical Facility 2
Draper, Utah, United States
Medical Facility
Draper, Utah, United States
Medical Facility
Pleasant Grove, Utah, United States
Medical Facility
Salt Lake City, Utah, United States
Medical Facility
Falls Church, Virginia, United States
Medical Facility
Manassas, Virginia, United States
Medical Facility
Norfolk, Virginia, United States
Medical Facility
Kingwood, West Virginia, United States
Medical Facility
Morgantown, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Puttagunta S, Aronin SI, Gupta J, Das AF, Gupta K, Dunne MW. Sulopenem versus Amoxicillin/Clavulanate for the Treatment of Uncomplicated Urinary Tract Infection. NEJM Evid. 2025 Jul;4(7):EVIDoa2400414. doi: 10.1056/EVIDoa2400414. Epub 2025 Jun 24.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IT001-310
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.