NCT03354598
Completed
Phase 3
A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
ConditionsUncomplicated Urinary Tract Infections
Overview
- Phase
- Phase 3
- Intervention
- Sulopenem-Etzadroxil/Probenecid
- Conditions
- Uncomplicated Urinary Tract Infections
- Sponsor
- Iterum Therapeutics, International Limited
- Enrollment
- 1671
- Locations
- 1
- Primary Endpoint
- Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
- •Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain
- •A mid-stream urine specimen with:
- •a dipstick analysis positive for nitrite AND
- •evidence of pyuria as defined by either:
- •i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine
- •Has given written informed consent to participate in the study.
Exclusion Criteria
- •Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature \> 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
- •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
- •Patients with ileal loops or urinary stoma
- •Patients with an indwelling urinary catheter in the previous 30 days
- •Patients with paraplegia
- •Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
- •Any history of trauma to the pelvis or urinary tract
- •Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
- •Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
Arms & Interventions
Sulopenem-etzadroxil/probenecid
Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days
Intervention: Sulopenem-Etzadroxil/Probenecid
Ciprofloxacin
Ciprofloxacin 250 mg PO administered twice daily for 3 days
Intervention: Ciprofloxacin
Outcomes
Primary Outcomes
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
Time Frame: Day 12+/-1 day
Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success
Time Frame: Day 12 +/- 1 day
Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Secondary Outcomes
- Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success(Day 12+/-1 day)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)Intra Abdominal InfectionsNCT03358576Iterum Therapeutics, International Limited674
Terminated
Phase 3
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine TumoursNeuroendocrine Tumors in LungNCT02683941Ipsen77
Completed
Phase 3
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back PainDegenerative Disc DiseaseNCT02412735Mesoblast, Ltd.404
Completed
Phase 3
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque PsoriasisPsoriasisNCT03701763Amgen245
Completed
Phase 3
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)Clostridium Difficile Infection (CDI)NCT03244644Rebiotix Inc.320
Related News
FDA Approves Oral Sulopenem (Orlynvah) for Uncomplicated Urinary Tract Infections• The FDA has approved oral sulopenem (Orlynvah) for uncomplicated urinary tract infections (uUTIs), offering a new treatment option amid rising antimicrobial resistance.
• Clinical trials SURE 1 and REASSURE demonstrated Orlynvah's superiority over ciprofloxacin in quinolone-resistant infections and a better response rate compared to amoxicillin/clavulanate.
• Orlynvah represents the first oral penem approved in the US, providing an alternative for patients with difficult-to-treat uUTIs and addressing the unmet need for novel antibiotics.
• Post-market monitoring will be crucial to prevent off-label use and ensure responsible utilization of this new antimicrobial agent in the face of increasing resistance.FDA Approves Sulopenem Etzadroxil/Probenecid (Orlynvah) for Uncomplicated UTIs• The FDA has approved sulopenem etzadroxil and probenecid (Orlynvah) for uncomplicated urinary tract infections (uUTIs) in adult women with limited oral treatment options.
• Backed by Phase 3 SURE 1 and REASSURE trials, Orlynvah demonstrated efficacy against _E. coli, K. pneumoniae_, and _P. mirabilis_, including antibiotic-resistant strains.
• As the first oral penem approved in the US, Orlynvah offers a novel alternative in the underserved uUTI market, addressing a critical need for new treatment options.
• The drug is administered orally twice daily for 5 days but is not indicated for complicated UTIs or intra-abdominal infections.FDA Approves Oral Sulopenem Etzadroxil and Probenecid (Orlynvah) for Uncomplicated UTIs• The FDA has approved sulopenem etzadroxil and probenecid (Orlynvah) for uncomplicated urinary tract infections (uUTIs) in adult women with limited oral antibacterial options.
• The approval was based on the SURE 1 trial, where sulopenem etzadroxil and probenecid showed superiority to ciprofloxacin in overall response rates.
• The REASSURE study demonstrated non-inferiority of sulopenem etzadroxil and probenecid compared to amoxicillin and clavulanic acid for uUTI treatment.
• Orlynvah offers a novel oral penem option to combat antimicrobial resistance in uUTI treatment, addressing an underserved market need.